A little late for some dead people but hey,
not really too important unless they happened to be your children. I am not impressed with how long this took.
Denise
Other Products:
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http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#wellbutrin
2004 Medical Product Safety Alerts, listed in reverse chronological
order (most recent first). For an alphabetical listing, return to
the categories on this page. You may also search the entire MedWatch
site by keyword at the top of this Safety Information page.
= Adobe Acrobat file (.pdf file), viewed with free Acrobat Reader
software. For more information, go to the MedWatch "downloads" page
at http://www.fda.gov/medwatch/getforms.htm
Serzone (nefazodone hydrochloride) Tablets
Audience: Neuropsychiatric healthcare professionals
FDA and Bristol-Myers Squibb notified healthcare professionals of
revisions to the INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION,
and WARNINGS sections to encourage healthcare providers to engage in
a thorough risk-benefit analysis, including consideration of the
risk of hepatic failure associated with Serzone treatment, when
deciding among alternative treatments available for depression. In
addition, healthcare providers and consumers are cautioned about the
need for close observation of patients being treated with
antidepressants for clinical worsening of the symptoms of
depression, for the emergence of suicidality, and for the emergence
of a variety of other symptoms that may represent a worsening of the
patient's condition.
[June 18, 2004 Letter - Bristol-Myers Squibb]
[April 2004 Revised Label - Bristol-Myers Squibb]
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Wellbutrin (bupropion hydrochloride) Tablets
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets
Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets
Audience: Neuropsychiatric healthcare professionals
FDA and GlaxoSmithKline notified healthcare professionals of
revisions to the WARNINGS and PRECAUTIONS sections of labeling to
alert healthcare professionals that patients with major depressive
disorder, both adult and pediatric, may experience worsening of
their depression and/or the emergence of suicidal ideation and
behavior (suicidality), whether or not they are taking
antidepressant medications. The warning recommends patients being
treated with antidepressants be observed closely for clinical
worsening and suicidality, especially at the beginning of a course
of drug therapy, or at the time of dose changes, either increases or
decreases.
[May 2004 Letter - GlaxoSmithKline]
[April 2004 Wellbutrin XL Revised Label - GlaxoSmithKline]
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Paxil (paroxetine hydrochloride) Tablets
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets
Audience: Neuropsychiatric healthcare professionals
FDA and GlaxoSmithKline notified healthcare professionals of
revisions to the WARNINGS and PRECAUTIONS sections of labeling to
alert healthcare professionals that patients with major depressive
disorder, both adult and pediatric, may experience worsening of
their depression and/or the emergence of suicidal ideation and
behavior (suicidality), whether or not they are taking
antidepressant medications. The warning recommends patients being
treated with antidepressants be observed closely for clinical
worsening and suicidality, especially at the beginning of a course
of drug therapy, or at the time of dose changes, either increases or
decreases.
[May 2004 Letter - GlaxoSmithKline]
[April 2004 Paxil Revised Label - GlaxoSmithKline]
[April 2004 Paxil CR Revised Label - GlaxoSmithKline]
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Domperidone
Audience: Consumers and healthcare professionals
FDA warned healthcare professionals and breastfeeding women not to
use an unapproved drug, domperidone, to increase milk production
(lactation). The agency is concerned with the potential public
health risks associated with domperidone. FDA took these actions
because it has become aware that some women are purchasing this drug
from compounding pharmacies and from foreign sources. Although
domperidone is approved in several countries outside the U.S. to
treat certain gastric disorders, it is not approved in any country,
including the U.S., for enhancing breast milk production in
lactating women and is also not approved in the U.S. for any
indication.
[June 10, 2004 FDA Talk Paper - FDA]
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Roche Diagnostics Tecan Clinical Workstation
Audience: Clinical laboratory specialists and healthcare
professionals
FDA and Roche Diagnostics notified healthcare professionals of a
Class I Recall for the Tecan Clinical Workstation (TCW), used with
Roche Diagnostics Amplicor CT/NG test for the detection of Chlamydia
and gonorrhea. A software error in the workstation software may
cause a mismatch among patient samples and test results resulting in
false positive and false negative results. This could lead to
mistreatment and unneeded exposure to antibiotics. Untreated
Chlamydia and gonorrhea infections may lead to pelvic inflammatory
disease, infertility, ectopic pregnancy, or other conditions.
[UPDATE June 18, 2004 - Recall information added for COBAS GUI
Interface and RoboNet software]
[June 09, 2004 Recall Notice - FDA]
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Crestor (rosuvastatin)
Audience: Physicians, pharmacists, and other healthcare
professionals
FDA issued a Public Health Advisory notifying healthcare
professionals of a revised package insert for use in the 22 member
states of the European Union (EU). The changes to the European
labeling are in response to adverse event reports in patients
receiving Crestor and highlight certain patient populations who may
be at an increased risk for serious muscle toxicity (myopathy)
associated with Crestor use, especially at the highest approved dose
of 40 mg. These risk factors and many of the recommendations for how
to minimize the risk of myopathy are already captured in the FDA
approved labeling for Crestor in the U.S. FDA alerted physicians to
carefully read the Crestor product label and follow the
recommendations for starting doses, dose adjustments, and maximum
daily doses to minimize the risk of myopathy in individual patients.
[June 09, 2004 Public Health Advisory - FDA]
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Arjo MINSTREL Patient Lifts
Audience: Hospital and nursing home administrators and risk managers
FDA and Arjo, Inc. notified healthcare professionals of a Class I
recall of the MINSTREL patient lift. There are two mechanical
problems associated with the lifts: the first involves the hanger
bar detaching from the lift, resulting in the patient falling to the
ground because of a missing spring washer; the second problem
involves a bolt in the foot pedal assembly becoming loose which
allows the foot pedal assembly to fall off of the lift. This results
in the lift becoming unstable and the patient possibly falling.
Facilities should either inspect their lifts and follow the
instructions in the Field Correction/Recall letter sent to all
facilities or they should take the lifts out of service until they
can be inspected by an Arjo service engineer.
[May 27, 2004 Recall Notice - FDA]
[May 26, 2004 Press Release - Arjo, Inc.]
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Paradigm Quick-set Plus Insulin Administration Set
Audience: Healthcare professionals, hospital risk managers
FDA and Medtronic, Inc. notified healthcare professionals of a Class
I recall of Quick-set Plus infusion sets because of problems with
bending of the infusion set's cannula or unintentional disconnection
of the set at the insertion site that can interrupt insulin flow to
diabetics who use them. These problems have resulted in a number of
serious injuries, including some hospitalizations.
[May 20, 2004 Recall Notice - FDA]
[May 18, 2004 Press Release - Medtronic, Inc.]
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Children's Motrin Grape Chewable Tablets
Audience: Pharmacists and consumers
FDA and McNeil alerted healthcare professionals that one
manufacturing lot (Lot # JAM108, exp 1/06) of Children's Motrin
(ibuprofen) Grape Chewable Tablets may mistakenly contain Tylenol 8-
Hour extended release (acetaminophen) Geltabs. Lot # JAM108 was
distributed nationwide to wholesale and retail customers between
February 5 and April 1, 2004. The bottles are labeled as containing
24 tablets. The Tylenol 8-Hour product provides an adult dose of
acetaminophen, and use of this adult product could provide more than
the recommended dose (overdose) for children.
[May 12, 2004 Press Release - McNeil Consumer & Specialty
Pharmaceuticals]
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PRECISE RX Nitinol Stent Transhepatic Biliary System
Audience: General surgeons and endovascular healthcare professionals
Cordis and FDA notified healthcare professionals of a Class 1 recall
for the revised instructions for use, not cleared by the FDA, and
contained in a notification mailed to Cordis' endovascular customers
on March 29, 2004. Use of the stent system, indicated for treatment
of obstruction of the bile duct due to malignancies, is reported to
result in serious problems in some cases when used in the vascular
system.
On May 4, 2004 Cordis sent a follow-up notification to customers
describing nine patient injuries due to air embolism, including
seizure and coma, as well as seven incidents of device malfunction
in connection with the use of this system outside of its approved
indication. Cordis stated that they were recalling the March 29,
2004 instructions with a strong recommendation that physicians limit
their use of the PRECISE RX Stent to indicated uses only.
[May 04, 2004 Recall Notice - FDA]
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Desyrel (trazodone hydrochloride)
Audience: Neuropsychiatric healthcare professionals
FDA and Bristol-Myers Squibb notified healthcare professionals of
revisions to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of
the Desyrel labeling. Desyrel is indicated for the treatment of
depression. In vitro drug metabolism studies suggest that there is a
potential for drug interactions when trazodone is given with the
CYP3A4 inhibitors ketoconazole, ritonavir, and indinavir. It is
likely that CYP3A4 inhibitors may lead to substantial increases in
trazodone plasma concentrations with the potential for adverse
effects. If trazodone is used with a potent CYP3A4 inhibitor, a
lower dose of trazodone should be considered. Conversely,
carbamazepine reduced plasma concentrations of trazodone when
coadministered. Patients should be closely monitored to see if there
is a need for an increased dose of trazodone when taken with
carbamazepine.
[May, 2004 Letter - Bristol-Myers Squibb]
[September, 2003 Label - Bristol-Myers Squibb]
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Oxandrin (oxandrolone, USP)
Audience: Physicians, pharmacists, and other healthcare professionals
Savient Pharmaceuticals, Inc. notified healthcare professionals of
an important drug interaction between Oxandrin, a synthetic
derivative of testosterone, and the oral anticoagulant warfarin for
systemic anticoagulation. Oxandrin is indicated as adjunctive
therapy to promote weight gain and for the relief of the bone pain
frequently accompanying osteoporosis. Concurrent dosing of Oxandrin
and warfarin may result in unexpectedly large increases in the
International Normalized Ratio (INR) or prothrombin time (PT). When
Oxandrin is prescribed to patients being treated with warfarin,
doses of warfarin may need to be decreased significantly to maintain
a desirable INR level and diminish the risk of potentially serious
bleeding.
[April 20, 2004 Letter - Savient Pharmaceuticals]
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Zelnorm (tegaserod maleate)
Audience: Gastroenterologists and other healthcare professionals
The FDA and Novartis notified healthcare professionals of an
important drug warning and prescribing information for Zelnorm, a
serotonin 5-HT4 receptor partial agonist indicated for the short-
term treatment of women with irritable bowel syndrome (IBS) whose
primary bowel symptom is constipation. This new information relates
to a Warning for serious consequences of diarrhea and a Precaution
for rare reports of ischemic colitis in post marketing use of
Zelnorm.
[April 26, 2004 Letter - Novartis]
[April 2004 Revised Label - Novartis]
[April 28, 2004 Drug Information Page - FDA]
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Medtronic Micro Jewell II Model 7223Cx and GEM DR Model 7271
Implantable Cardioverter Defibrillators (ICD)
Audience: Cardiologists and other healthcare professionals
The FDA notified healthcare professionals of a Class I recall of
implantable cardioverter defibrillators (ICDs) from Medtronic Inc.
of Minneapolis, Minnesota. Some Medtronic ICDs were found to have
defective high voltage capacitors that may take longer than normal
to charge near the end of the battery service life and could cause a
delay in delivery or a non-delivery of shock therapy. This could
result in patient injury or death because patients are not receiving
the appropriate therapy in time. A total of 6,268 of the affected
ICDs were manufactured, of which about 1,800 are thought to be still
implanted in patients worldwide. Patients with Medtronic ICDs with
these model numbers should contact their physicians for further
information and advice.
[April 4, 2004 Recall Notice - FDA]
[April 16, 2004 Press Release - Medtronic]
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Cytotec Solutions, Inc. Products
Audience: Consumers, pharmacists, and other healthcare professionals
FDA warned consumers not to purchase or consume products marketed
as "street drug alternatives" by Cytotec Solutions, Inc., of Tampa,
Fla. FDA analyses of products manufactured or distributed by Cytotec
Solutions Inc., found the drugs diphenhydramine HCl,
dextromethorphan, ephedrine, and the controlled substances GBL and
GHB. Although this firm is no longer producing these products, they
remain under investigation and FDA is working to identify and
address additional distributors of the products. The agency is
issuing this warning because consumers may still have these products
in their possession or may be able to buy them commercially. A list
of product names is included in the FDA Press Release.
[April 9, 2004 Press Release - FDA]
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Abilify (aripiprazole)
Audience: Neuropsychiatric healthcare professionals
FDA and Bristol-Myers Squibb notified healthcare professionals of
revision to the WARNINGS section of labeling, describing the risk of
hyperglycemia and diabetes in patients taking Abilify. FDA asked all
manufacturers of atypical antipsychotic medications, including
Bristol-Myers Squibb, to add this Warning statement to labeling.
[March 25, 2004 Letter - FDA]
[March, 2004 Revised label - Bristol-Myers Squibb]
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Seroquel (quetiapine fumarate)
Audience: Neuropsychiatric healthcare professionals
FDA and AstraZeneca notified healthcare professionals of revision to
the WARNINGS section of labeling, describing the increased risk of
hyperglycemia and diabetes in patients taking Seroquel. FDA has
asked all manufacturers of atypical antipsychotic medications,
including AstraZeneca, to add this Warning statement to labeling.
[UPDATE - April 22, 2004 Letter - AstraZeneca]
[January 30, 2004 Letter - AstraZeneca]
[January 2004 Revised Label - AstraZeneca]
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Clozaril (clozapine)
Audience: Neuropsychiatric healthcare professionals
FDA and Novartis notified healthcare professionals of revision to
the WARNINGS section of labeling, describing the increased risk of
hyperglycemia and diabetes in patients taking Clozaril. FDA has
asked all manufacturers of atypical antipsychotic medications,
including Novartis, to add this Warning statement to labeling.
[April 1, 2004 Letter - Novartis]
[December 2003 Revised Label - Novartis]
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Absorbable Hemostatic Agents
Audience: Surgeons and operating room supervisory personnel
The FDA Center for Devices and Radiological Health (CDRH) issued a
Public Health Notification concerning a serious adverse event that
can occur with the use of an absorbable hemostatic agent, a device
used to promote coagulation and stop internal bleeding during
surgical procedures. Since 1996, FDA has received reports of over
110 adverse events related to absorbable hemostatic agents. Eleven
of the events resulted in paralysis or other neural deficits. These
events continue to occur despite specific advice and warnings in the
device labeling. CDRH provided recommendations to minimize the risk
of adverse events in patients receiving an absorbable hemostatic
agent during a surgical procedure.
[April 02, 2004 Public Health Notification - FDA]
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VITEK GPS-107 gram positive susceptibility cards
Audience: Clinical laboratory specialists and healthcare
professionals
(March 26, 2004) bioMerieux, Inc. of Hazelwood, Missouri issued a
Class I recall of VITEK GPS-107 gram positive susceptibility cards,
lot M83X, catalog #V4368. These cards are used with the VITEK System
in clinical laboratories as a in-vitro test to determine patient's
susceptibility of various bacteria to antibiotic treatment. Some of
the GPS-107 cards were stamped with an incorrect card code causing
the system to read and report the cards incorrectly. Use of the
defective cards may pose a risk of potentially life threatening
consequences due to inaccurate test results. (Updated 4/1/2004 to
provide correct lot number.)
(UPDATE May 14, 2004) bioMerieux expanded its recall to include an
additional lot, B28E.
[April 20, 2004 Recall Notice - FDA]
[January 28, 2004 Recall Notice - FDA]
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Major Twice-A-Day 12 Hour Nasal Spray
Audience: Pharmacists and consumers
Propharma, Inc., Miami, Florida issued a recall of Major Twice-A-Day
12 Hour Nasal Spray (Lot #K4496, Exp 10/06) because the lot was
contaminated with Burkholderia cepacia bacteria. This product is a
nasal decongestant containing the active ingredient oxymetazoline
hydrochloride 0.05%. The entire lot was distributed nationwide to
wholesalers, pharmacies, hospitals and retailers. Use of this
contaminated product could cause serious or potentially life-
threatening infections in patients with compromised immune systems,
particularly individuals with cystic fibrosis. The lot number and
expiration date are found on the bottom of the carton and the back
of the bottle label.
[UPDATE March 26, 2004 Press Release - Propharma]
[March 18, 2004 Press Release - Propharma]
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Zyprexa (olanzapine)
Audience: Neuropsychiatric healthcare professionals
FDA and Lilly notified healthcare professionals of revision to the
WARNINGS section of labeling, describing the increased risk of
hyperglycemia and diabetes in patients taking Zyprexa. FDA has asked
all manufacturers of atypical antipsychotic medications, including
Lilly, to add this Warning statement to labeling.
[March 2004 Letter - Lilly] PDF version
[January 2004 Revised Label - Lilly]
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Public Health Advisory: Antidepressant Use in Children, Adolescents,
and Adults
Audience: Neuropsychiatric healthcare professionals and consumers
The FDA asked manufacturers of the following antidepressant drugs to
include in their labeling a Warning statement that recommends close
observation of adult and pediatric patients for worsening depression
or the emergence of suicidality when treated with these agents. The
drugs that are the focus of this new Warning are: Prozac
(fluoxetine); Zoloft (sertraline); Paxil (paroxetine); Luvox
(fluvoxamine); Celexa (citalopram); Lexapro (escitalopram);
Wellbutrin (bupropion); Effexor (venlafaxine); Serzone (nefazodone);
and Remeron (mirtazapine).
[March 22, 2004 Public Health Advisory - FDA]
[March 22, 2004 Drug Information Page - FDA]
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Faaborg Patient Lifts
Audience: Hospital and nursing home administrators and risk managers
The FDA notified healthcare professionals of a Class I recall of
Faaborg battery operated patient lifts distributed by Moving
Solutions, Inc., of Downers Grove, Ill., because of a faulty design.
Excessive wear of the main bolt, which secures the lift arm to the
main frame of the patient lift, will cause the bolt to break which
will cause the patient to fall and could result in serious injury,
even death. FDA has received one report of death related to the
failure of the bolt. Facilities should stop using these lifts until
the problem is corrected.
[March 09, 2004 Recall Notice - FDA]
[March 09, 2004 Press Release - FDA]
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Duragesic (fentanyl transdermal system)
Audience: Pharmacists, other healthcare professionals, and consumers
(February 20, 2004) Janssen Pharmaceutica and FDA notified
healthcare professionals of a Class I recall of DURAGESIC 75 mcg/h.
Only Control Number 0327192 (expiration October 2005) is subject to
this recall. A potential seal breach on one edge may allow drug to
leak from the patch and could result in an increased absorption of
the opioid component, fentanyl, leading to increased drug effect,
including nausea, sedation, drowsiness, or potentially life
threatening complications. Conversely, if the hydrogel contents leak
out of the patch, there may not be adequate medication to treat the
patients' pain. In an opioid tolerant patient, this may lead to
withdrawal symptoms, which include sweating, sleeplessness and
abdominal discomfort.
(UPDATE April 9, 2004) Janssen expanded its US recall to include 5
manufacturing lots. See updated information below.
[UPDATE April 7, 2004 Pharmacist Recall Notification - Janssen]
[UPDATE April 2, 2004 Dear Health Care Professional Letter -
Janssen]
[February 17, 2004 Recall Notice - Janssen]
[February 17, 2004 Product Photos - Janssen]
[February 16, 2004 Patient and Caregiver Information - Janssen]
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Counterfeit contraceptive patches
Audience: Reproductive healthcare professionals and consumers
FDA and Johnson and Johnson Co. of Raritan, NJ are warning the
public about an overseas internet site selling counterfeit
contraceptive patches that contain no active ingredients.The
counterfeit contraceptive patches were promoted as Ortho Evra
transdermal patches, which are FDA approved, and made by Johnson and
Johnson's Ortho-McNeil Pharmaceutical, Inc. subsidiary. These
counterfeit patches provide no protection against pregnancy.
Consumers who have any of these products should not use them, but
instead contact their healthcare providers immediately.
[February 4, 2004 Talk Paper - FDA]
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Viramune (nevirapine)
Audience: Infectious disease and other healthcare professionals
Boehringer Ingelheim and FDA notified healthcare professionals of
new safety information added to the WARNINGS and Boxed Warning for
VIRAMUNE. Severe, life-threatening, and in some cases fatal
hepatotoxicity, including fulminant and cholestatic hepatitis,
hepatic necrosis and hepatic failure, has been reported in patients
treated with VIRAMUNE. These events are often associated with rash.
Women, and patients with higher CD4 counts, are at increased risk of
these hepatic events. Women with CD4 counts >250 cells/mm3,
including pregnant women receiving chronic treatment for HIV
infection, are at considerably higher risk of these events.
Prodromal signs and symptoms, risk information and monitoring
recommendations have been added to the labeling.
[February 2004 Letter - Boehringer Ingelheim]
[February 2004 Revised label - Boehringer Ingelheim]
[January 2004 Guidelines: Management of Rash/Hepatic Events with
Viramune - Boehringer Ingelheim]
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OTC pain and fever reducers (acetaminophen / NSAIDs)
Audience: Pharmacists, other healthcare professionals, and consumers
The FDA notified healthcare professionals of a national education
campaign to provide advice on the safe use of over-the-counter (OTC)
pain and fever reducers that contain acetaminophen and non-steroidal
anti-inflammatory drugs (NSAIDs). The campaign is intended to raise
consumer awareness of these safety issues and to inform healthcare
providers about the role that they can play in preventing
acetaminophen induced hepatotoxicity and NSAID-related
gastrointestinal bleeding and renal toxicity in patients using these
medicines.
[January 22, 2004 Drug Information Page - FDA]
[January 22, 2004 Science Backgrounder - FDA]
[January 22, 2004 Letter to State Boards of Pharmacy - FDA]
[January 22, 2004 Press Release - FDA]
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Antibody to HBsAg ELISA Test System 3
Antibody to HBsAg ELISA Test System 3 Confirmatory Test
Audience: Blood bank and other laboratory professionals
Ortho-Clinical Diagnostics Inc. and FDA notified healthcare
professionals of reports of increased initial reactive (IR) and
repeat reactive (RR) rates obtained with the Antibody to HBsAg ELISA
Test System 3 donor screening assay, with false repeat reactive
results being confirmed using the Antibody to HBsAg ELISA Test
System 3 Confirmatory Test. Ortho is currently examining available
information as to the causes of these events. The letter recommended
measures to mitigate problems with the donor screening assay, and
provided changes made to the instructions for use of the Antibody to
HBsAg ELISA Test System 3 Confirmatory Test kit.
[December 23, 2003 Letter - Ortho-Clinical Diagnostics Inc.]
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Web page last revised by jlw June 23, 2004
Denise Marhoefer
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