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Recalls and Alerts
(2007) |
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10/19/2007
Pfizer Terminates
Manufacturing of Inhaled Insulin
(Exubera)
Pfizer Inc announced that
it is no longer making inhaled insulin
(Exubera). The decision is not based on any
safety concerns but is due to economic
feasibility resulting from too few patients
taking the inhaled insulin. Pfizer will work
with physicians to transition patients from
inhaled insulin to other treatment options over
the next several months. Exubera was approved by
the US Food and Drug Administration in January
2006 as the first inhaled insulin.
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10/18/2007
PDE5 Inhibitors and
Hearing Loss
The prescribing
information for phosphodiesterase type 5 (PDE5)
inhibitors (eg, sildenafil [Viagra, Revatio],
tadalafil [Cialis], vardenafil [Levitra]) has
been changed to include information regarding
sudden decreases in hearing or loss of hearing.
PDE5 inhibitors are indicated for the treatment
of erectile dysfunction, and sildenafil
(Revatio) is specifically indicated for the
treatment of pulmonary arterial hypertension. In
some individuals, tinnitus and dizziness
accompanied the hearing impairment. Medical
follow-up on these reports was often limited,
causing difficulty in determining if the hearing
loss was related to the use of one of the drugs,
an underlying medical condition, other risk
factors for hearing loss, a combination of these
factors, or other unknown variables.
More information is
available at FDA MedWatch.
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10/16/2007
Exenatide (Byetta) and
Acute Pancreatitis
The prescribing
information for exenatide (Byetta) has been
updated to include reports of acute
pancreatitis. Thirty incidences of acute
pancreatitis have been reported in patients
taking exenatide, a drug used to treat adults
with type 2 diabetes mellitus. An association
between exenatide and acute pancreatitis is
suspected in some of these cases.
Health
care professionals should be alert to the signs
and symptoms of acute pancreatitis. Symptoms
include persistent severe abdominal pain that
may radiate to the back and may be accompanied
by nausea and vomiting. Elevated serum amylase
and/or lipase levels are characteristic
laboratory values associated with acute
pancreatitis. Patients taking exenatide who
experience these adverse effects should seek
prompt medical care. If pancreatitis is
suspected, exenatide should be discontinued. If
pancreatitis is confirmed, exenatide should not
be restarted unless another etiology is
identified.
More information is
available at FDA MedWatch.
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10/16/2007
Medtronic Sprint Fidelis
Defibrillation Leads—Marketing and Sales
Suspended
Medtronic has voluntarily
suspended distribution of its Sprint Fidelis
defibrillation leads because fractures have been
detected. Sprint Fidelis leads will no longer be
sold or manufactured, and any remaining product
should be pulled from inventory and returned to
the company.
When a defibrillator lead
is slightly more prone to fracture, most leads
will function well. However, infrequently, a
lead may actually break, or "fracture"; the lead
may send false signals that cause inappropriate
or undelivered defibrillator shocks.
About 268,000 leads have been implanted
worldwide, and fractures have occurred in less
than 1%. Patients who are implanted with this
lead should contact their physicians for further
information.
More information is
available at FDA MedWatch.
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10/15/2007
FulLife Natural Options
Products Seized by US Marshals
US Marshals seized
approximately $71,000 worth of dietary
supplements from FulLife Natural Options, Inc
(Boca Raton, FL). Charantea Ampalaya capsules
and Charantea Ampalaya Tea are dietary
supplements confiscated because of claims made
by the manufacturer that they treat serious
illnesses (eg, diabetes mellitus, anemia,
hypertension).
According to US Food and
Drug Administration (FDA) standards, these
products are considered unapproved new drugs
because they make claims related to the
prevention or treatment of diseases in the
products’ labeling. Before a new drug product
may be legally marketed, it must be shown to be
safe and effective and must be approved by the
FDA. This action protects consumers who may rely
on unapproved products and unsubstantiated
claims associated with these products when
making important decisions about their health.
Following an investigation of the firm's
marketing practices, the FDA told FulLife that
the claims related to prevention or treatment of
diseases made these products subject to
regulation as drugs. Despite the FDA's warnings,
the firm failed to bring its marketing into
compliance with the law. During subsequent
inspections, the FDA inspectors found that the
offending claims were still being made.
More information is
available at FDA MedWatch.
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10/12/2007
Two Microbubble Contrast
Agents for Echocardiography Now Include Boxed
Warnings
The US Food and Drug
Administration (FDA) has requested that boxed
warnings be added to the labeling of 2 contrast
agents used in echocardiography. The contrast
agents affected by this request are perflutren
liquid microspheres (Definity; Bristol-Myers
Squibb) and perflutren protein-type A
microspheres for injection (Optison; General
Electric).
The warning following reports
of 11 deaths and 199 serious cardiopulmonary
reactions associated with the use of the
aforementioned microbubble contrast agents
during or within 30 minutes following
echocardiography. Ten of the deaths and 190 of
the serious reactions were related to the use of
Definity. The Optison product has not been on
the market since 2005 because of a manufacturing
problem but is expected to be reintroduced in
the near future.
The use of Definity has
not been established with exercise or
pharmacological stress testing. Also, use is
contraindicated in patients at risk for
cardiopulmonary reactions, particularly patients
with cardiac shunts; patients who are clinically
unstable or who have had recent worsening of
congestive heart failure; and patients with
symptomatic arrhythmias or those who are at high
risk for arrhythmias due to QT prolongation,
respiratory failure, severe emphysema, pulmonary
emboli, or other conditions that compromise
pulmonary arterial vasculature.
More information is
available at FDA MedWatch.
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10/10/2007
Full Immunization
Emphasized With Cochlear Implants
The US Food and Drug
Administration (FDA) has received 2 reports of
cochlear implants associated with death
secondary to an increased risk of bacterial
meningitis caused by Streptococcus
pneumoniae. Children with cochlear implants
with a positioner component are at a greater
risk (see previous eMedicine Alerts from
February 6, 2006 and August 1, 2003). The
cochlear implant devices are used in patients
who are profoundly deaf or have severe hard of
hearing.
The 2 deaths from meningitis
were reported within the past year in children
implanted with the cochlear implant with the
positioner component. These children were not
fully immunized according to the Centers for
Disease Control and Prevention (CDC) recommended
vaccination schedule (see the 2nd link provided
below). These children, aged 9 and 11 years, had
completed only part of the recommended
pneumococcal vaccinations for their age group.
At least one of the children had meningitis
caused by a serotype of S pneumoniae
that may have been prevented by proper
vaccinations.
Recipients of cochlear
implants must be fully immunized according to
the CDC vaccination recommendations. Because
children with cochlear implants are at increased
risk for pneumococcal meningitis, the CDC
recommends that they receive pneumococcal
vaccination under the same schedules that apply
to other individuals at high risk for invasive
pneumococcal disease.
More information is
available at FDA MedWatch.
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10/1/2007
FDA Evaluates Risk of
Atrial Fibrillation With
Bisphosphonates
The US Food and Drug
Administration (FDA) published an early
communication that discusses the relationship of
atrial fibrillation (AF) with the use of
bisphosphonates. This communication is in
response to recently published articles in the
May 3, 2007, New England Journal of
Medicine.
In one of the studies,
the use of intravenous zoledronic acid resulted
in decreased vertebral and hip fractures
compared with the placebo group. The unexpected
adverse effect of serious AF was also observed
and occurred more frequently in the zoledronic
acid group compared with placebo (50 vs 20
patients, p<0.001). However, among the 50
patients taking zoledronic acid who experienced
AF, the arrhythmia occurred more than 30 days
after the zoledronic acid infusion (N Engl J
Med. 2007;356[18]:1809-1822). See the
second link provided below for
abstract.
In the same issue of the
New England Journal of Medicine, a
letter to the editor described AF events in a
separate study of another bisphosphonate,
alendronate. This study showed 47 serious AF
events (1.5%) among patients who received
alendronate compared with 31 events (1%) among
those receiving placebo during an average of 4
years (N Engl J Med.
2007;356[18]:1895-96). See the third link
provided below for abstract.
Upon initial
review, it is unclear how these data on serious
atrial fibrillation should be interpreted. The
FDA does not believe that health care providers
or patients should change either their
prescribing practices or their use of
bisphosphonates at this time.
Because of
these data, the FDA is further examining the
possibility of an increased risk of AF with the
use of bisphosphonates. The FDA is continuing to
monitor spontaneous postmarketing reports of AF
in patients taking bisphosphonates and is
seeking additional data to allow for an in-depth
evaluation of the entire class of
bisphosphonates.
Bisphosphonates are a
class of drugs used to increase bone mass and to
reduce the risk for fracture in patients with
osteoporosis. Bisphosphonates are also used to
slow bone turnover in patients with Paget
disease of the bone and to treat bone metastases
and lower elevated blood calcium levles in
patients with cancer. The 7 FDA-approved
bisphosphonates are alendronate (Fosamax,
Fosamax Plus D), etidronate (Didronel),
ibandronate (Boniva), pamidronate (Aredia),
risedronate (Actonel, Actonel with calcium),
tiludronate (Skelid), and zoledronic acid
(Reclast, Zometa).
More information is
available at FDA MedWatch.
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9/27/2007
Class I Recall Issued for
Exacta-Mix 2400 Operating Software Version 1.07
Pharmacy Compounding System
A class I recall has been
issued for Exacta-Mix 2400 Operating Software
Version 1.07 Pharmacy Compound System (Model No.
8300-0073, Baxa Corporation). The recall affects
32 devices that were distributed to 14 customers
in the United States and to 1 customer outside
of the United States from June 4, 2007 through
June 25, 2007.
The device is a
compounding system used in pharmacies to add and
mix various ingredients into one intravenous
(IV) solution. The recall was issued because a
software failure allowed up to 50 mL extra
volume of an ingredient to be added to the IV
solution that can be life-threatening,
particularly in newborns.
Immediately
stop using the admixing system and contact the
manufacturer for a replacement. A class I recall
is issued when a drug or device has a reasonable
probability of causing serious adverse health
risks, including death, to some users.
More information is
available at FDA MedWatch.
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9/21/2007
Axcil and Desirin Dietary
Supplements Recalled
A nationwide recall has
been issued for Axcil and Desirin, both of which
are marketed as dietary supplements and are
promoted for erectile dysfunction. The products
contain undeclared ingredients that are
potentially harmful to consumers.
The US
Food and Drug Administration (FDA) laboratory
analysis of Axcil and Desirin found that lot
number 02B07 contained 3 mg/g of sildenafil. The
products also contained sulfosildenafil and
sulfohomosildenafil, which are analogs of
sildenafil. Sildenafil is an FDA-approved
product (marketed as Viagra) and is indicated
for erectile dysfunction. Sildenafil and
sildenafil analogs may interact with nitrates
found in some prescription drugs (eg,
nitroglycerin) and may cause profound
hypotension.
Consumers with diabetes,
hypertension, hypercholesterolemia, or
cardiovascular diseases are often prescribed
nitrates. Sexual dysfunction is a common problem
with these conditions, and consumers may seek
these types of products to enhance sexual
performance. Consumers who have these products
should immediately stop using them and consult
with their health care professional if they
experience any problems that may be due to these
products. |
9/21/2007
Cryptosporidium Infection
Linked to Baby’s Bliss Gripe Water
A recall has been issued
for the apple flavor of Baby’s Bliss Gripe Water
(distributed by MOM Enterprises, Inc.). The
product affected by the recall is coded with
26952V and an expiration date of October 2008
(10/08). The recall was initiated because
laboratory findings confirmed the presence of
Cryptosporidium in the product during
an investigation into an illness in a 6-week old
infant who consumed the product. Baby’s Bliss
Gripe Water is an herbal supplement promoted to
ease gas and stomach discomfort often associated
with colic, hiccups, and teething in infants and
children.
Cryptosporidium is a parasite
that can cause intestinal infections. Infected
infants, children, pregnant women, and those
with weakened immune systems are particularly
susceptible to severe dehydration that results
from diarrhea caused by Cryptosporidium
infection. Other symptoms include dehydration,
weight loss, stomach cramps or pain, fever,
nausea, and vomiting. Onset of symptoms is
typically 2-10 days after infection with the
parasite and lasts about 1-2 weeks. For more
information, see the eMedicine topic Cryptosporidiosis.
Children who have
recently consumed the apple flavor of Baby's
Bliss Gripe Water and have these symptoms need
immediate medical attention. Consumers should
stop using this product and immediately discard
or return bottles of the product.
More information is
available at FDA MedWatch.
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9/18/2007
Class I Recall Issued for
MRL/Welch Allyn AED 20 Automatic External
Defibrillators
The United States Food and
Drug Administration (FDA) has issued a class I
recall for MRL/Welch Allyn AED 20 Automatic
External Defibrillators. The recall affects the
devices manufactured between October 2003 and
January 2005 and includes serial numbers 205787
through 207509. Emergency or medical personnel
use the devices to treat adult and pediatric
patients in cardiopulmonary arrest. The recalled
devices may display a "Defib Comm" error message
during use that results in a terminal failure of
the device to analyze the patient's ECG and
deliver the appropriate therapy.
The FDA
advises to stop using the recalled AEDs
immediately and contact the manufacturer for a
replacement. A class I recall is issued when a
drug or device has a reasonable probability of
causing serious adverse health risks, including
death, to some users.
More information is
available at FDA MedWatch.
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9/17/2007
Intravenous Haloperidol
May Cause Life-Threatening Arrhythmias
The United States Food and
Drug Administration (FDA) has announced that the
prescribing information for haloperidol (Haldol,
generic versions) has been revised to include a
new cardiovascular subsection in the Warnings
section. Life-threatening arrhythmias (eg,
sudden death, QT prolongation, torsades de
pointes) have been reported in patients treated
with haloperidol, especially when haloperidol is
administered intravenously (IV) or at doses
higher than recommended.
Injectable
haloperidol is only FDA-approved for
intramuscular injection, although considerable
evidence exists that intravenous administration
is a fairly common off-label clinical practice.
A minimum of 28 cases of QT prolongation and
torsades de pointes have been reported following
intravenous administration, and some have
resulted in death.
More information is
available at FDA MedWatch.
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9/14/2007
Normal Saline Flush
Syringes Recalled Because of Particles in
Solution
A recall has been issued
for Normal Saline Flush Syringes (by B. Braun
Medical Inc) with lot numbers ending in "SFR".
The recall was prompted because of increased
customer complaints of particulate matter in the
saline. The introduction of particular matter
into the bloodstream may result in phlebitis,
damage to vital organs, or both. Pulmonary
embolism or silicone embolism syndrome, which
could cause severe injury, death, or both, are
rare possibilities. To date, B. Braun Medical
Inc has received no reports of any patient
injury associated with this issue.
The
recalled normal saline syringes are described as
follows:
- Product code 513584 and
lot number SFR
- 3 mL (in 12-mL syringes)
- Approximately 33,000
units distributed between June 11 and July 18,
2007
- Product code 513587 and
lot number SFR
- 10 mL (in 12-mL syringes)
- Approximately 1.2 million
units distributed between June 11 and July 18,
2007
Customers and patients who possess
the recalled syringes should discontinue use
immediately.
More information is
available at FDA MedWatch.
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9/13/2007
Fentanyl Buccal Tablets
Require Proper Patient Selection and Precise
Dosage
Cephalon issued two "Dear
Health Care Professional" letters to inform
prescribers and other health care providers of
important safety information regarding fentanyl
buccal tablets (Fentora). Fentanyl buccal
tablets are indicated only for the management of
breakthrough pain in patients with cancer who
are already receiving and who are tolerant to
opioid therapy for their underlying persistent
cancer pain.
Serious adverse events,
including deaths, have occurred in patients
treated with Fentora. These deaths occurred as a
result of improper patient selection (eg, use in
patients not tolerant to opioid therapy),
improper dosing, and/or improper product
substitution. Appropriate patient selection and
proper dosing and administration of Fentora are
essential to reduce the risk of respiratory
depression.
Key safety information for
Fentora is as follows:
- Do NOT use in patients
not tolerant to opioid therapy.
- Use only for labeled
indications.
- Do not prescribe for
patients with acute pain, postoperative pain,
headache, migraine, or sports injuries.
- Do not substitute;
Fentora is not a generic version of Actiq or
other fentanyl-containing products.
- Follow dosing
instructions carefully.
- For unrelieved
breakthrough pain (BTP), patients should NOT
take more than 2 Fentora tablets per BTP
episode.
- Patients must wait at
least 4 hours before treating another BTP
episode with Fentora.
More information is
available at FDA MedWatch.
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9/11/2007
Ceftriaxone and Calcium
Warning
Roche has contacted health
care professionals to clarify the potential risk
associated with concomitant use of intravenously
(IV) administered ceftriaxone (Rocephin) with
calcium or calcium-containing IV solutions or
products. Ceftriaxone and calcium-containing
solutions (including continuous IV infusions of
calcium, such as parenteral nutrition) should
not be mixed or coadministered to any patient
irrespective of age, even via different IV
infusion lines at different sites. Also, do not
administer ceftriaxone within 48 hours of IV
calcium-containing solutions. Fatalities caused
by calcium-ceftriaxone precipitants in the lung
and kidney have been reported (see eMedicine
Recalls and Alerts July 5, 2007).
Interaction data is unavailable
regarding ceftriaxone and oral
calcium-containing products or intramuscular
ceftriaxone and calcium-containing products (IV
or oral).
More information is
available at FDA MedWatch.
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9/11/2007
Blood Glucose
Meters—Screen Malfunction When Dropped
Abbott notified users of
blood glucose meters (Precision Xtra, Optium,
ReliOn Ultima, Rite Aid, Kroger, manufactured
after January 31, 2007) to check the meter’s
screen if dropped onto a hard surface. When
dropped, part of the display can be jarred or
disconnected, resulting in the inability to read
the lot number or date information. Dropping the
meter can also cause the screen to appear blank,
and blood glucose test results can not be seen.
This may cause a significant risk for
hypoglycemia or hyperglycemia.
Patients
should stop using the meter immediately if
unable to read the screen. The meters come with
a wallet that provides additional protection for
the meter. If dropped, immediately perform a
meter display check. Instructions on how to do
this are detailed in the meter’s Users Guide. If
no problems are encountered during the automatic
display check, the meter is ready for use.
More information is
available at FDA MedWatch.
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9/10/2007
Nelfinavir (Viracept)
Impurity Prompts New Guidelines for Children and
Pregnant Women
Pfizer has alerted health
care professionals about the possible presence
of a process-related impurity in nelfinavir
(Viracept). The impurity is ethyl
methanesulfonate (EMS), a potential human
carcinogen. Guidance regarding nelfinavir’s use
in pregnant women and pediatric patients was
also provided.
Data from animal studies
indicate EMS is teratogenic, mutagenic, and
carcinogenic; however, no data from humans
exist. The US Food and Drug Administration (FDA)
has asked Pfizer to implement new specifications
to limit the presence of EMS in nelfinavir.
The FDA and Pfizer agree that pediatric
patients who are stable on nelfinavir-containing
regimens, should continue to receive nelfinavir
because the benefit-to-risk ratio remains
favorable. Pediatric patients who need to begin
human immunodeficiency virus (HIV)-treatment
should not start regimens that contain
nelfinavir until further notice. Also, pregnant
women who need to begin antiretroviral therapy
should not be offered regimens that contain
nelfinavir until further notice. As a
precautionary measure, pregnant women currently
receiving nelfinavir should be switched to an
alternative antiretroviral therapy while Pfizer
and the FDA work to implement the long-term EMS
specification for nelfinavir. For pregnant women
with no alternative treatment options, the FDA
and Pfizer agree that the riskto--benefit ratio
remains favorable for the continued use of
nelfinavir. Other patients should continue to
receive nelfinavir because available information
shows the benefits of HIV-1 antiretroviral
treatment outweigh the risk of stopping HIV
treatment.
More information is
available at FDA MedWatch.
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9/7/2007
Zencore Dietary
Supplement Recalled – Contains Undeclared Drug
Ingredients
The US Food and Drug
Administration (FDA) has issued a nationwide
recall for the dietary supplement, Zencore Tabs.
Upon analysis by the FDA laboratory, Zencore
Tabs were found to contain aminotadalafil, an
analog of tadalafil (Cialis) and sildenafil
(Viagra), and sulfosildenafil and
sulfohomosildenafil, also analogs of sildenafil.
Tadalafil and sildenafil are active ingredients
of drugs that are FDA-approved for erectile
dysfunction. All of these undeclared ingredients
may interact with nitrates (eg, nitroglycerin)
and cause dangerous hypotension.
Consumers should immediately stop using
Zencore and consult their health care provider
if problems occur.
More information is
available at FDA MedWatch.
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8/21/2007
Metabolism Apple Cider
Vinegar Dietary Supplement Recalled
Metabolism Apple Cider
Vinegar brand dietary supplement capsules have
been recalled because one lot contained the
undeclared drug sibutramine (Meridia), a US Food
and Drug Administration (FDA)-approved appetite
suppressant for weight loss. The affected lot
number is 3001006, expiration October 2009 (UPC
Code: 9248300102). Metabolism Apple Cider
Vinegar is not an approved drug. The use of
sibutramine may cause hypertension and
tachycardia, thereby posing significant risk for
patients with coronary artery disease,
congestive heart failure, arrhythmias, or
stroke.
Consumers should return any
unused product to the manufacturer.
More information is
available at FDA MedWatch.
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8/17/2007
Codeine Rapid Metabolizer
Use Cautioned When Breastfeeding
The US Food and Drug
Administration (FDA) has issued a Public Health
Advisory warning about very rare but serious
adverse effects (eg, excessive sleeping,
breathing difficulties, limpness) in nursing
infants whose mothers are taking rapidly
metabolize codeine. Codeine may be prescribed
for analgesia or as an antitussive agent.
Following ingestion, codeine is
metabolized to morphine. Numerous variables
affect codeine metabolism, including genetic
make-up. Some individuals have a variation in a
liver enzyme (ie, CYP2D6) and may rapidly and
completely metabolize codeine to morphine. If
breastfeeding mothers rapidly metabolize
codeine, the morphine levels in the breast milk
may be increased. These higher levels of
morphine may lead to life-threatening or fatal
adverse effects in nursing infants.
Physicians should choose the lowest
effective dose for the shortest period of time
when prescribing codeine-containing drugs to
breastfeeding mothers and should closely monitor
the infant. In most cases, the rate at which the
mother metabolizes codeine is unknown. A test
can determine the patient’s CYP2D6 genotype;
however, this test is not routinely used in
clinical practice but is available through a
number of different laboratories. The test
results reveal whether a person converts codeine
to morphine at a faster rate than average,
resulting in higher morphine levels in the
blood. If these morphine levels are too high,
patients have an increased risk of adverse
events.
More information is
available at FDA MedWatch.
|
8/16/2007
Specific Genes Affect
Warfarin Dosage Requirements
The prescribing
information for warfarin (Coumadin) has been
updated with information that explains how
genetic makeup may influence drug response.
Specifically, individuals with variations in 2
genes may need lower warfarin doses than
individuals without these genetic variations.
The 2 genes are called CYP2C9 and VKORC1. The
CYP2C9 gene is involved in warfarin metabolism,
and the VKORC1 gene helps to regulate the
ability of warfarin to prevent blood from
clotting.
Patients carrying at least one
copy of the CYP2C9*2 allele or CYP2C9*3 allele
required a mean daily warfarin dose that was 17%
and 37% less than patients who carry the
CYP2C9*1 allele, respectively.
Vitamin K
epoxide reductase (VKOR) is a multiprotein
enzyme complex and, when inhibited by warfarin,
reduces the regeneration of vitamin K. Single
nucleotide polymorphisms in the VKORC1 gene
(particularly the 1639G>A allele) are
associated with lower warfarin dose
requirements.
Warfarin is used for a
broad range of indications that require
anticoagulation. Warfarin dosage and
administration is highly individualized.
Measurements of prothrombin time (PT) and
international normalized ratios (INRs) are
required to precisely adjust the dose on a
regular basis. In addition to current standards
of practice regarding warfarin dosage and
monitoring, the new information regarding the
impact of genetic information on the initial
dose and the response to warfarin will further
assist clinicians.
More information is
available at FDA MedWatch.
|
8/14/2007
Cardiovascular Risk
Warning Added to Entire Thiazolidinedione Drug
Class
The United States Food and
Drug Administration (FDA) has determined that
the prescribing information for the entire
antidiabetic drug class of thiazolidinediones
(ie, rosiglitazone, pioglitazone) should contain
a boxed warning that describes heart failure
risks. This decision follows an extensive review
of postmarketing adverse event reports.
The strengthened warning advises health
care professionals to observe patients carefully
for the signs and symptoms of heart failure,
including excessive, rapid weight gain;
shortness of breath; and edema after starting
drug therapy. Discontinuation or dose reduction
should be considered if the aforementioned
symptoms occur. Additionally, initiating
thiazolidinediones are contraindicated in
patients with New York Heart Association (NYHA)
Class III or IV heart failure.
The
proprietary names of drugs whose prescribing
information will contain a black boxed warning
include the following:
- Avandia (rosiglitazone)
- Actos (pioglitazone)
- Avandaryl (rosiglitazone
and glimepiride)
- Avandamet (rosiglitazone
and metformin)
- Duetact (pioglitazone and
glimepiride)
More information is
available at FDA MedWatch.
|
8/13/2007
Accidental Overdose of
Kaletra Causes Infant Death
Abbott Laboratories has
sent a global communication to health care
providers to alert them regarding an accidental
overdose involving lopinavir/ritonavir oral
solution (Kaletra), which resulted in the death
of an infant. The accidental overdose occurred
in a 44-day-old infant, born at 30 weeks
gestation with human immunodeficiency virus
(HIV) infection. The infant was administered 6.5
mL (about 10 times the calculated dose) and died
9 days later of cardiogenic shock.
Accurate dose calculation of the
medication order, dispensing information, and
dosing instructions are essential to minimize
the risk of errors. Lopinavir/ritonavir oral
solution is highly concentrated and contains 80
mg of lopinavir and 20 mg of ritonavir per mL.
The prescribing information contains precise
dosage guidelines for children. Dosage for
children whose weight is less than 15 kg is 12
mg/kg orally twice daily (dose calculation is
based on lopinavir component). Current
prescribing information can be viewed in the
second link provided below.
More information is
available at FDA MedWatch.
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8/9/2007
Red Yeast Rice Dietary
Supplements Found to Contain
Lovastatin
The US Food and Drug
Administration (FDA) has warned consumers not to
buy or consume 3 red yeast rice products sold on
Web sites and promoted as dietary supplements
used to lower cholesterol. FDA testing revealed
that the products contained the prescription
drug lovastatin (the active ingredient in
Mevacor), which is approved for marketing in the
United States and other countries to treat high
cholesterol.
The suspect products
include the following:
- Red Yeast Rice (Sold by
Swanson Healthcare Products, Inc; manufactured
by Nature’s Value Inc)
- Policosonal Complex (Sold
by Swanson Healthcare Products, Inc;
manufactured by Kabco Inc)
- Cholestrix (Sold by
Sunburst Biorganics)
Lovastatin is known to cause
rhabdomyolysis, a myopathy that may lead to
renal failure. The risk of developing
rhabdomyolysis increases when high doses are
administered or when lovastatin is concurrently
administered with some food (eg, large
quantities of grapefruit juice) or drugs, such
as nefazodone, other cholesterol agents (eg,
gemfibrozil, niacin), certain antibiotics (eg,
erythromycin, clarithromycin), antifungal agents
(eg, itraconazole, ketoconazole), cyclosporine,
or drugs used to treat human immunodeficiency
virus HIV infection (eg, amprenavir, atazanavir,
ritonavir). Consumers should consult their
health care provider regarding the use of
dietary supplements.
More information is
available at FDA MedWatch.
|
8/7/2007
Baxter Expands Class I
Recall for Volumetric Infusion Pumps
Baxter Healthcare and the
US Food and Drug Administration (FDA) have
expanded the previous class I recall (see
eMedicine Recalls and Alerts 7/20/07) for
Colleague and Flo-Gard volumetric infusion pumps
to include an additional 986 Colleague infusion
pumps.
Models of the infusion pumps
affected by the recall include the following:
- Colleague Mono (Product
code 2M8151 and 2M8153)
- Colleague CX (Product
code 2M8161 and 2M8163)
- Flo-Gard 6201 (Product
code 2M8063)
- Flo-Gard 6301 (Product
code 2M8064)
The products were recalled because
Baxter identified falsified data sheets for
repair, inspection, and testing (including
electrical safety data). As a result, pumps sent
to be serviced, repaired, or corrected were
possibly returned without receiving service.
More information is
available at FDA MedWatch.
|
7/30/2007
Moricizine (Ethmozine)
Discontinued From Market
Shire Pharmaceuticals has
announced that they will discontinue moricizine
(Ethmozine) because of diminished market demand.
Supplies of moricizine will diminish over the
next several months, and no generic version is
available. Physicians should contact patients
currently taking moricizine to evaluate
alternative forms of antiarrhythmic therapy.
Moricizine is indicated for the
treatment of documented ventricular arrhythmias
(eg, sustained ventricular tachycardia) that in
the judgment of the physician are
life-threatening. Caution is advised when
moricizine is tapered at the same time that
another antiarrhythmic drug is initiated because
of possible additive pharmacologic effects.
Please refer to important safety information in
the prescribing information. During the tapering
process, patients are at high risk for
life-threatening arrhythmias. Because of this
high risk, a cardiologist should initiate
moricizine tapering and withdrawal with close
patient monitoring in place.
More information is
available at FDA MedWatch.
|
7/27/2007
Restricted Use of
Tegaserod (Zelnorm) Permitted
The US Food and Drug
Administration (FDA) is permitting restricted
use of tegaserod (Zelnorm) under a treatment
investigational new drug (IND) protocol. The
treatment IND allows tegaserod administration in
women younger than 55 years who have irritable
bowel syndrome (IBS) with constipation or
chronic idiopathic constipation (CIC). Its use
is further restricted to those in critical need
who have no known or preexisting heart disease.
Information regarding the treatment IND is
available from Novartis Pharmaceuticals Corp at
(888) 669-6682.
Earlier this year,
tegaserod marketing was suspended because of
safety analysis findings that revealed an
increased risk of heart attack, stroke, and
unstable angina in patients treated with
tegaserod compared with patients treated with
placebo (see eMedicine Recalls and Alerts from
March 30, 2007).
More information is
available at FDA MedWatch.
|
7/20/2007
Class I Recall Issued for
Baxter Upgraded Colleague Triple Channel
Volumetric Infusion Pumps
A class I recall has been
issued for Baxter Upgraded Colleague Triple
Channel Volumetric Infusion Pumps. The model
numbers affected by the recall include 2M8153,
2M8163, and 2M9163. The infusion pumps are used
to deliver controlled amounts of injectable
medications or other fluids by intravenous (IV),
intra-arterial (IA), epidural, or other direct
routes into the bloodstream.
The recall
is due to a software problem that causes the
newly upgraded pumps to display an error code
(16:310:867:0002) and to stop the infusion. The
software malfunction has occurred when
programmed with all 3 channels simultaneously
infusing fluids. Reports of serious injuries
associated with this issue due to the pump
stopping the infusion and interrupting therapy
have been described.
All affected triple
channel pumps need to be immediately removed
from service. Baxter Medical Delivery Services
may be contacted at
1 (800) 843-7867. A class
I recall is issued when a drug or device has a
reasonable probability of causing serious
adverse health risks, including death, to some
users.
More information is
available at FDA MedWatch.
|
7/13/2007
Class I Recall of
Ascencia Contour Blood Glucose Monitoring
System
A class I recall has been
issued for Bayer Ascensia Contour Blood Glucose
Monitoring System, Product 7152A. This system is
used by patients with diabetes for outpatient
measurement of blood glucose and as an aid to
monitor blood glucose control.
The recall
was initiated because the meters reported the
wrong measurement units for Canadian users.
Instead of mmol/L, which is the appropriate
measurement for Canadian users, the meters were
reporting mg/dL. This error may cause
misinterpretation of the blood glucose results
displayed, particularly an overestimation of
blood glucose levels. As a result, hypoglycemia
may occur if doses of antidiabetic agents are
increased based on misinterpreted results.
Patients with questions should call Bayer
Healthcare at 1 (574) 256-3441.
More information is
available at FDA MedWatch.
|
7/5/2007
Ceftriaxone and Calcium
Incompatibility Causes Neonatal
Deaths
The prescribing
information for ceftriaxone (Rocephin, Roche
Laboratories Inc) has been updated to include
new information that describes the risk
associated with concomitant use of calcium or
calcium-containing solutions. Fatalities caused
by calcium-ceftriaxone precipitants in the lung
and kidney have been reported in both full-term
and premature neonates. The drug must not be
mixed with simultaneously administered with
calcium-containing solutions or products, even
via separate infusion lines. Ceftriaxone and
calcium-containing solutions or medications were
administered via different routes and at
different times in some fatal cases.
Additionally, calcium-containing solutions or
products must not be administered within 48
hours of ceftriaxone administration.
The
new information has been added to several
sections of the prescribing information,
including contraindications, warnings, dosage
and administration, directions for use, and
compatibility and stability.
More information is
available at FDA MedWatch.
|
7/5/2007
Ertapenem (Invanz)
Recalled
A recall has been issued
for ertapenem injection (Invanz, Merck &
Co). The affected lots include 0803930, 0803940,
and 0803950. All lots have an expiration date of
October 2008. The recall was prompted by 2
reports of broken glass pieces in the
reconstituted solution for injection. Health
care professionals are advised to immediately
stop dispensing all products from the affected
lots specified above. No other lots are affected
by this recall.
Ertapenem injection is
indicated for the treatment of
moderate-to-severe infections including
intra-abdominal infections, skin and skin
structure infections, community-acquired
pneumonia, urinary tract infections, and pelvic
infections.
More information is
available at FDA MedWatch.
|
7/2/2007
Boxed Warning for
Anaphylaxis Added to Omalizumab (Xolair)
Prescribing Information
A new boxed warning has
been added to the prescribing information for
omalizumab (Xolair, Genentech, Inc). The US Food
and Drug Administration (FDA) had requested that
Genentech add a boxed warning in February
because of the risk for anaphylaxis. See
eMedicine Recalls and Alerts February 21, 2007.
Anaphylaxis may occur after the first dose but
may also occur beyond one year of regular
treatment. The onset of anaphylaxis caused by
omalizumab may be delayed for 24 hours or
longer.
Because of the risk for
anaphylaxis, omalizumab should only be
administered in a health care setting, where
professionals can treat life-threatening
anaphylaxis using the appropriate medications
and equipment. Following each omalizumab
injection, patients should be observed under
direct medical supervision before going home. A
medication guide has also been developed to
inform patients of risks and to help them
understand signs and symptoms that require
immediate medical attention.
More information is
available at FDA MedWatch.
|
6/28/2007
FDA Investigates Death of
Patient With Cystic Fibrosis and Inhaled
Colistimethate
The United States Food and
Drug Administration (FDA) has issued a health
advisory concerning the possible connection
between inhaled colistimethate and the death of
a patient with cystic fibrosis
(CF).
Colistimethate is FDA-approved for
treatment of acute or chronic infections caused
by sensitive strains of certain gram-negative
bacilli, particularly sensitive strains of
Pseudomonas aeruginosa that are a
significant problem for patients with CF and for
patients with neutropenia and/or immune system
compromise. Use as a liquid intended for
inhalation via nebulizer is an off-label
indication; however, in patients with CF,
colistimethate is often mixed with sterile water
for injection to form a solution immediately
before inhalation via nebulizer. Once mixed with
sterile water and a buffer, spontaneous
hydrolysis occurs, causing colistimethate to
form colistin, the bioactive compound. Polymyxin
E1, a component of colistin, is toxic to lung
tissue. Premixing colistimethate into an aqueous
solution and storing it for longer than 24 hours
results in increased concentrations of colistin
in solution and increases the potential for lung
toxicity.
In this circumstance, the
lyophilized powder of colistimethate was
reconstituted and dispensed by a pharmacy as
prescribed in premixed unit dose ready-to-use
vials. Once colistimethate is reconstituted, the
product breaks down into other chemicals that
can damage lung tissue.
More information is
available at FDA MedWatch.
|
6/15/2007
Kawasaki Disease – Link
to Vaccine Unclear
The prescribing
information for rotavirus vaccine (RotaTeq by
Merck) has been updated to include information
regarding the observation of Kawasaki disease
during phase 3 clinical trials and postmarketing
surveillance. Six cases of Kawasaki disease were
reported during the phase 3 clinical trial. Five
cases of Kawasaki disease were reported in
36,150 infants who received the rotavirus
vaccine and one case was reported in 35,536
infants who received placebo. Three cases of
Kawasaki disease have been reported to the
Vaccine Adverse Event Reporting System (VAERS)
since the vaccine was licensed on February 3,
2006.
No known cause-and-effect
relationship between the administration of
rotavirus vaccine or any other vaccine and the
occurrence of Kawasaki disease has been
established. The cases reported to date are not
more frequent than what could be expected to
occur by coincidence. The US Food and Drug
Administration (FDA) and the Centers for Disease
Control and Prevention (CDC) will continue to
monitor the safety of rotavirus vaccine and all
vaccines and encourage that all severe adverse
events, including any additional cases of
Kawasaki disease, be reported to
VAERS.
Kawasaki disease is a serious, but
uncommon, illness in children with an unknown
etiology. It is characterized by an acute
febrile vasculitic syndrome that affects the
lymph nodes, skin, mouth, and heart. For more
information regarding Kawasaki disease, see the
second link provided below.
More information is
available at FDA MedWatch.
|
6/15/2007
Long Weekend Dietary
Supplement Recalled
A nationwide recall has
been issued for the dietary supplement Long
Weekend, a product sold through mail orders and
retailers throughout the United States, Puerto
Rico, Canada, the United Kingdom, Russia, and
China. The recall was prompted because Long
Weekend was found to contain undeclared
tadalafil, a drug approved by the US Food and
Drug Administration (FDA) to treat male erectile
dysfunction (ED). Tadalafil is known to interact
with nitrates found in some prescription drugs
(eg, nitroglycerin) and may lower blood pressure
to dangerous levels. Long Weekend is not
approved by the FDA; therefore, the safety and
effectiveness of this product is unknown.
Consumers should discontinue use of Long Weekend
and consult their health care provider about
approved treatments for ED.
More information is
available at FDA MedWatch.
|
6/15/2007
Proper Intravenous
Sterile Technique Emphasized for
Propofol
The US Food and Drug
Administration (FDA) has informed health care
providers that several groups of patients have
experienced chills, fever, and body aches
shortly after the administration of propofol
(Diprivan) for sedation or general anesthesia.
Multiple vials and several lots of propofol used
in patients who experienced these symptoms were
tested, and no evidence has suggested that the
propofol vials or the prefilled syringes used
were contaminated with bacteria or endotoxins.
Propofol is an intravenous
sedative-hypnotic agent indicated for induction
and maintenance of anesthesia or sedation.
Propofol is available as an oil-in-water
emulsion. The potential for bacterial
contamination can be minimized by using propofol
vials and prefilled syringes within 6 hours of
opening. Each vial should be used for one
patient only. Patients who develop fever,
chills, body aches, or other symptoms of acute
febrile illness shortly after propofol
administration should be evaluated for bacterial
sepsis. Careful handling and aseptic technique
are essential in avoiding bacterial
contamination of intravenous products.
Failure to use aseptic technique when
handling propofol has resulted in microbial
contamination that has resulted in fever,
infection, sepsis, life-threatening illness, and
death. For more information, see the prescribing
information for propofol provided in the second
link below.
More information is
available at FDA MedWatch.
|
6/8/2007
Class I Recalled Issued
for Troponin-1 Immunoassay
A class I recall has been
issued for Architect Stat Troponin-1
Immunoassay. The assay is used to diagnose
myocardial infarction in people with chest pain.
A small number of clinical laboratories reported
inconsistent or invalid test results at the
lower levels of troponin-1 detection (ie,
<0.1 ng/mL). Falsely elevated or falsely
decreased results at and near this low level
were observed, making diagnosis difficult to
interpret and thereby affecting patient
treatment. Laboratories are advised to be
cautious when reporting results at or near the
lower limit of detection and to advise
physicians ordering the tests about the
possibility of inaccurate test results at those
levels.
More information is
available at FDA MedWatch.
|
6/5/2007
Class 1 Recall Issued for
CustomCornea LASIK Algorithm for
Myopathy
A class I recall has been
issued for Alcon Refractive Horizons LADAR6000
Excimer Laser System for CustomCornea algorithm
for myopia with astigmatism (M3) and myopia
without astigmatism (A7). This system is used
for LASIK and wavefront-guided LASIK treatment
for the reduction or elimination of
mild-to-moderate nearsightedness (myopia) and
farsightedness (hyperopia) with or without
astigmatism or for mixed astigmatism.
The recall was prompted because use for
myopia with and without astigmatism caused
corneal abnormalities (central islands) and
decreased visual sharpness (visual acuity) in
patients. These central islands may not be
correctable with lasers, and the decrease in
visual acuity may not be correctable with
glasses or contact lenses.
A Class I
recall is issued when a drug or device has a
reasonable probability to cause serious adverse
health risks, including death, to some users.
More information is
available at FDA MedWatch.
|
5/29/2007
Similac Special Care
Premature Infant Formula With Iron
Recalled
A nationwide recall has
been issued for Similac Special Care
Ready-to-Feed Premature Infant Formula with Iron
(2 ounce, 24 calories/fluid ounce). The formula
is specifically used for premature infants
following hospital discharge. The recall was
issued because the affected lots do not contain
as much iron as indicated on the label.
The recall affects 3 lots distributed in
the United States between November 2006 and May
2007. The recall is limited to stock code number
59582 with lot numbers 46815D5, 47847D5, or
52023D5 printed on the outside carton and case
and the lot numbers 44427X8, 4427X81, or 50005X8
printed on the bottom of the bottles. No other
liquid or powdered Similac infant formulas are
affected.
More information is
available at FDA MedWatch.
|
5/26/2007
Contact Lens Solution
Recalled
A recall has been issued
for Complete MoisturePlus Multipurpose Contact
Lens Solution manufactured by Advanced Medical
Optics. The solution is used for soft contact
lenses. The United States Centers for Disease
Control and Prevention (CDC) identified an
association between Complete MoisturePlus
Multipurpose Contact Lens Solution and reports
of a rare but serious eye parasitic infection,
Acanthamoeba keratitis.
Acanthamoeba keratitis has been
known to cause vision loss, and, in some
patients, a corneal transplant is required. The
infection affects otherwise healthy people who
wear contact lenses.
Acanthamoeba keratitis
infections are estimated to occur in about 2 of
every 1 million contact lens users in the United
States each year. In a multistate investigation
conducted by the CDC to assess a recent increase
in Acanthamoeba keratitis infections,
the risk for infection was discovered to be at
least 7 times greater for consumers who used
Complete MoisturePlus Solution versus those who
did not. Additional information regarding these
results is available at the CDC Web site in the
second link provided below.
Consumers
who possess the solution may call the company at
(888) 899-9183. Consumers should stop using the
solution, discard all partially used or unopened
bottles, and replace their lenses and storage
container.
More information is
available at FDA MedWatch.
|
5/25/2007
FDA Halts Marketing of
Unapproved Guaifenesin Products
The United States Food and
Drug Administration (FDA) is taking action
against drug manufacturers marketing unapproved
guaifenesin timed0release products. Guaifenesin
is an expectorant that is commonly used for
cough and cold symptoms. Approximately 20 firms
make timed-released guaifenesin products that
have not undergone FDA review and as a result
are considered unapproved drugs.
Immediate release forms of guaifenesin
are not affected. Timed-release drugs require
FDA approval because the FDA must ensure that
the product releases its active ingredients
safely and effectively, sustaining the intended
effect over the entire time in which the product
is intended to work.
To date, only Adams
Respiratory Therapeutics has obtained FDA
approval for timed-release guaifenesin products
(600 milligrams and 1200 milligrams) under the
trade names of Mucinex and Humibid. These
include over-the-counter products containing
guaifenesin alone (Mucinex, Humibid), with the
decongestant pseudoephedrine (Mucinex-D), and
with the cough suppressant dextromethorphan
(Mucinex-DM).
More information is
available at FDA MedWatch.
|
5/25/2007
Class I Recall Issued for
All EnDura Products
A Class I recall has been
issued for all EnDura No-React Dural Substitute
(EnDura) products. These products are
manufactured by Shelhigh Inc and distributed by
Integra. The recall was prompted by a
notification from the United States Food and
Drug Administration (FDA) that cited
manufacturing concerns including sterility. All
EnDura products that may remain from the first
shipment date by Integra in 2003 to present are
affected by the recall.
A Class I recall
is issued when a drug or device has a reasonable
probability to cause serious adverse health
risks, including death, to some users.
More information is
available at | | | | | |
