Safety Information Summaries
1997
Summaries of "Dear Health Professional" letters and other safety notifications of
which MedWatch is aware. Listed in reverse chronological order.
Current as of:
May 7, 1998
(Click on the type of medical
product to go directly to those products and then click on the product of interest to go
to the summary for that product.)
NOTE: These summaries do not include all of the information
contained in the letter or other notification; therefore, to see the full text, click on the underlined type of notification at the end of each summary.
Drugs:
Accolate (zafirlukast)
Claritin-D (loratadine/pseudoephedrine sulfate)
Cordarone (amiodarone HCl)
Epivir (lamivudine)
Fragmin (dalteparin Na) (Posted: 12/15/97, Updated: 5/7/98)
Genotropin (recombinant somatropin) (Posted: 11/25/97)
"Herbal Fen-Phen"(Posted: 11/6/97)
Ionamin (phentermine resin)
Ionamin (phentermine resin)
Lamictal (lamotrigine)
Lovenox (enoxaparin Na) (Posted: 12/15/97, Updated: 5/7/98)
MUSE (alprostadil)
(Posted: 4/8/98)
Normiflo (ardeparin Na) (Posted: 12/15/97, Updated: 5/7/98)
Orgaran (danaparoid Na) (Posted: 12/15/97, Updated: 5/7/98)
OTC Pain Relievers (Posted: 11/14/97)
Paremyd (hydroxyamphetamine hydrobromide/tropicamide)
"Phen/Fen" (phentermine & fenfluramine)
"Phen/Fen" (phentermine & fenfluramine) update
"Phen/Fen" treatment recommendations
(Posted: 11/13/97)
Phenolphthalein
Pondimin (fenfluramine)
Pondimin & Redux (fenfluramine & dexfenfluramine)
Pondimin & Redux (fenfluramine & dexfenfluramine) Market
Withdrawal
Posicor (mibefradil dihydrochloride)
(Posted: 12/18/97, Revised: 12/19/97)
Protease Inhibitors
Protease Inhibitors
(Posted: 12/15/97)
Rezulin (troglitazone) (Posted: 11/3/97)
Rezulin (troglitazone)
(Posted: 12/1/97 - Talk Paper, 12/8/97 - Letter)
Seldane (terfenadine)
Seldane (terfenadine)
Seldane (terfenadine) (Posted: 12/29/97)
Skin-Cap (OTC treatment for dandruff or psoriasis)
Sucostrin (succinylcholine)
Terbutaline Sulfate(Posted: 11/21/97)
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Dietary Supplements:
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Biologics:
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Medical Devices:
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Other Products:
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- Seldane (terfenadine)
- Hoechst Marion Roussel announces plans to withdraw prescription products
Seldane and Seldane-D which contain the antihistamine terfenadine
from the marketplace.
[December 29, 1997 (
Talk Paper) - FDA]
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- Laser Pointers
- FDA warns parents and school officials about the possibility
of eye damage to children from hand-held laser pointers.
[December 18, 1997 (
HHS NEWS) - FDA]
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- Posicor (mibefradil dihydrochloride)
-
New warnings have been added to the product's labeling. These warnings provide additional
information
about two risks associated with the drug - - extremely low heart rates, and, an interaction with
certain cholesterol lowering drugs resulting in a risk of muscle injury that can be
life-threatening.
[December 18, 1997 (
Talk Paper) - FDA]
[December 1997 (
Letter) - Roche]
[December 18, 1997 (Backgrounder) - FDA]
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- Anticoagulant Drugs (low molecular weight heparins & heparinoids)
-
FDA advises doctors to carefully monitor patients receiving low molecular weight heparins
or heparinoids (marketed as Lovenox, Fragmin,
Normiflo, and Orgaran). These drugs when used concurrently with spinal or epidural
anesthesia, or
spinal puncture may
cause bleeding or hematomas within the spinal column. Increased pressure on the spinal cord may
result in permanent paralysis if not detected and treated immediately.
[December 15, 1997 (
Talk Paper) - FDA]
[December 15, 1997 (
Public Health Advisory) - FDA]
[February 5, 1998 (
Advisory Committee Transcript) - FDA (300 pages)]
[May 7, 1998 (Questions and Answers - FDA]
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- Protease Inhibitors
-
There are currently four protease inhibitors approved for use in the U.S. These products are
members of a class of
antiretrovirals that are generally considered to be the most potent therapeutic agents for HIV to
date. In order for these drugs to be effective, and to minimize the risk of resistance, it is
important that these drugs are prescribed and taken in accordance with the products' approved
labeling.
[December 1997 (
Backgrounder) - FDA]
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- Rezulin (troglitazone)
-
FDA announces that patients taking the diabetes drug Rezulin (troglitazone) should be monitored
more frequently for signs of injury to the liver. Warning information about potential
liver toxicity will be more prominently featured in the drug's labeling.
[December 1, 1997 (
Talk Paper) - FDA]
[December 1, 1997 (
Letter) - Parke-Davis]
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- OTC Pain Relievers
-
FDA announces that it intends to require an alcohol warning on all over-the-counter pain
relievers, which include aspirin, other salicylates, acetaminophen,
ibuprofen, ketoprofen, and naproxen sodium.
[November 14, 1997 (
HHS News) - FDA]
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-
Terbutaline Sulfate
-
FDA is
alerting the health community that the unapproved ("off-label") continuous
subcutaneous administration, via infusion pump, of terbutaline sulfate for the treatment and
prevention of preterm labor (tocolytic therapy).
has not been
demonstrated to be effective and
is potentially dangerous.
[November 13, 1997 (
Letter) - FDA]
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-
"Phen-Fen"
-
With the withdrawal of fenfluramine and dexfenfluramine from the US market, many people have asked what they should do
if they have taken these drugs. In order to try to provide guidance, based on the best information known at present, the
Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institutes of Health
(all components of Department of Health and Human Services) collaborated with experts within the medical community to
develop interim recommendations for patients. The interim recommendations were published in the November 14th issue of the
Morbidity and Mortality Weekly Report (MMWR).
[November 13, 1997 (
Recommendations) - FDA/CDC/NIH]
[November 13, 1997 (
HHS News) - FDA]
[November 13, 1997 (
Questions & Answers) - FDA]
[November 13, 1997 (
What to Include in a MedWatch Report on Valvular Dysfunction) - FDA]
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-
Genotropin (recombinant somatropin)
-
Two recently concluded studies of the use of
recombinant somatropin (Genotropin) for treatment of acute catabolism in critically ill
patients found that for the two studies combined,
the mortality rate was 18.2% in placebo-treated patients (48/264) and 41.7% in the
somatropin-treated patients (108/259). As a result, the company recommends that further
use of recombinant somatropin (Genotropin) for treatment of
acute catabolism, including pre- and post-operative treatment, critically ill patients and
burn patients be stopped immediately.
This recommendation to stop treatment DOES NOT
apply to the use of Genotropin for the approved indication of treatment of children
who have growth failure due to inadequate secretion of endogenous growth hormone.
[November 10, 1997 (Letter) - Pharmacia & Upjohn]
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-
"Herbal Fen-Phen"
-
FDA warns consumers that "herbal fen-phen" products marketed as alternatives to the
prescription
drugs phentermine and fenfluramine (commonly referred to as "fen-phen")
are considered unapproved drugs. Unapproved drugs have not been shown to be safe or
effective and may
contain ingredients that have been associated with injuries.
[November 6, 1997 (
Talk Paper - FDA]
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-
Rezulin (troglitazone)
- Prescribing information has been changed regarding the
incidence of idiosyncratic hepatocellular injury in patients
with type 2 diabetes. Reported cases range from mild elevations of serum
transaminases to one liver transplant and one death. Parke-Davis
recommends that serum transaminase levels be checked within the first
one to two months and then every three months during the first year
of troglitazone therapy, and periodically thereafter. Liver function
tests also should be obtained for patients at the first symptoms suggestive
of hepatic dysfunction.
[October 28, 1997 (Letter) - Parke-Davis]
[November 3, 1997 (
Talk Paper - FDA]
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- MUSE (alprostadil)
- The company notifies health professionals of changes to the package insert regarding 1) reports of
syncope occurring within one hour of administration; 2) the potential for drug-drug interaction
when MUSE
is prescribed concomitantly with anti-hypertensives; 3) some lowering of blood pressure may
occur without symptoms; and 4) swelling of leg veins, leg pain, perineal pain, and rapid pulse,
each occurring in < 2% of patients, during in-clinic titration and home treatment.
[September 1997 (
Letter)- Vivus]
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-
Home-Use Test Kits
- FDA warns consumers and pharmacists about two unapproved, fraudulently
marketed
home-use test kits distributed
by Lei-Home Access Care. The kits are labeled as "Lei-Home Access HIV Test" and
"In-Home Hepatitis A Test Kit".
Results from any unapproved test for home use are unreliable.
[September 26, 1997 (HHS News) - FDA]
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-
Seldane (terfenadine)
- Hoechst Marion Roussel notifies health professionals that the co-administration of
the recently approved agent
Posicor (mibefradil dihydrochloride) with Seldane/Seldane-D is contraindicated. In addition, the
drug
interactions section of the labeling for Seldane/Seldane-D have been updated to include the
following:
HIV protease inhibitors [e.g., indinavir (Crixivan), ritonavir (Norvir), saquinavir
(Invirase), and
nelfinavir (Viracept)], serotonin reuptake inhibitors [e.g., fluvoxamine (Luvox),
nefazodone
(Serzone), and sertaline (Zoloft)], zileuton (Zyflo), cisapride (Propulsid), and
sparfloxacin
(Zagam). Also, the labeling has been updated to recommend a dosage adjustment of
Seldane/Seldane-D to one
(1) tablet daily for patients with significant renal impairment, particularly in patients
with a creatinine clearance below 40 mL/min.
[September 1997 (Letter) - Hoechst Marion Roussel]
[September 24, 1997 (Talk Paper)
- FDA]
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-
Ionamin (phentermine resin)
- Medeva Pharmaceuticals reminds health professionals that Ionamin is
indicated as monotherapy only. There are no data to support the safety
and/or
efficacy of combination therapy with phentermine and any other drug
products for the treatment of obesity, including
serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, paroxetine).
The coadministration of these agents is not recommended.
[September 18, 1997 (Letter) - Medeva]
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-
Pondimin (fenfluramine) and Redux (dexfenfluramine) Market Withdrawal
- Available data indicates that the antiobesity agents fenfluramine and dexfenfluramine
present an unacceptable risk
to patients who take them. FDA has asked the manufacturers of these products to
voluntarily withdraw them from the market.
[September 17, 1997 (Analysis of
Cardiac Valvular Dysfunction in Patients Treated with Appetite Suppressants - FDA]
[September 15, 1997 (HHS News) -
FDA]
[September 15, 1997, updated:9/18/97 (Questions & Answers about the
Withdrawal) - FDA]
[September 15, 1997 (Letter) - Wyeth Ayerst]
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-
Epivir (lamivudine)
- Glaxo Wellcome notifies health professionals that the the PRECAUTIONS section of
the package insert for Epivir has been changed to add the following new information -
"Patients with HIV
and Hepatitis B Virus Coinfection:
In clinical trials, some patients with HIV infection who have chronic liver disease due to
hepatitis B virus infection
experienced clinical or laboratory evidence of recurrent hepatitis upon
discontinuation of Epivir."
[September 8, 1997 (Letter) - Glaxo Wellcome]
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-
Phenolphthalein
- FDA proposes ban on OTC sale of the laxative ingredient phenolphthalein. OTC products
containing this ingredient would be required to either be reformulated or withdrawn from the
market.
[August 29, 1997 (HHS News) -
FDA]
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-
"Fen-Phen" (fenfluramine/phentermine) Update
- FDA strengthens its recent public warning that the use of a combination of
fenfluramine and phentermine in the treatment
of obesity has been associated with the development of serious cardiac disease.
The agency has
requested the manufacturers of phentermine, fenfluramine, and dexfenfluramine stress
this potential risk
in a black box warning in the drugs' labeling and in patient package inserts.
[August 27, 1997 (Talk Paper) -
FDA]
[August 28, 1997 (Update) - FDA]
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-
Vacuum Loss in Electronic Resonating Components
- FDA alerts medical device manufacturers to a recent failure mode involving vacuum loss
in
electronic resonating components. Electronic resonating components are frequently used in
medical devices, and their failure could have serious adverse effects on device function.
To FDA's knowledge
this problem has not been previously documented in the scientific literature.
[August 13, 1997 (Notice) - FDA]
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- Ionamin (phentermine resin)
- Medeva Pharmaceuticals has sent a Dear Health Care Professional letter to
US physicians informing them
of upcoming labeling changes for Ionamin which have been
proposed to the FDA. The revised labeling is the result of heightened
concern
regarding potential side effects which have been reported with
concomitant use of fenfluramine and phentermine ("fen/phen").
FDA has not yet concurred in the suggested wording and is
presently considering the company's proposal, along with those of other
manufacturers of the involved products. Once all proposals are submitted and
evaluated, FDA will request
labeling changes that it believes most appropriate in
light of the continuing information being accumulated about the use of these
drugs.
[August 8, 1997 (Letter) - Medeva]
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-
Skin-Cap
- FDA warns that OTC treatments for
dandruff or psoriasis called "Skin-Cap" contain prescription-strength
corticosteroids, which may pose a health hazard to many people. Individuals currently using
these
products are advised to immediately contact their health care providers.
[August 8, 1997 (Statement) - FDA]
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- Toxoplasma
IgM Commercial Test Kits
- FDA advises physicians that they should not use the
result from any
one Toxoplasma IgM commercial test kit as the sole
determinant of recent
Toxoplasma infection when screening a pregnant patient.
Because these tests can
have false-positive
results, reliance on a single test result could lead to misdiagnosis,
resulting in
unnecessary treatment of the patient and/or termination of the pregnancy.
[July 25, 1997 (Public Health Advisory) - FDA]
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- Pondimin & Redux (fenfluramine & dexfenfluramine)
- Wyeth Ayerst has sent a Dear Health Care Provider letter to
US physicians informing them
of labeling changes for Pondimin and Redux which have been
proposed to the FDA. The revised labeling is the result of heightened
concern
regarding potential side effects which have been reported with
concomitant use of fenfluramine and phentermine ("fen/phen").
FDA has not yet concurred in the suggested wording and is
presently considering the company's proposal, along with those of other
manufactuers of the involved products. Once all proposals are submitted and
evaluated, FDA will request
labeling changes that it believes most appropriate in
light of the continuing information being accumulated about the use of these
drugs.
[July 24, 1997 (Letter) - Wyeth-Ayerst]
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- Claritin-D 24 HOUR (loratadine/pseudoephedrine sulfate)
- The company has notified health professionals that the labeling for
Claritin-D 24 Hour has been changed. There have been rare postmarketing reports of
mechanical upper gastrointestinal tract obstruction in patients taking
Claritin-D 24 HOUR. Some patients required an endoscopy to remove the tablets.
In most cases, patients have had a history of difficulty in swallowing tablets
or have had known upper gastrointestinal narrowing or abnormal esophageal
peristalis. Patients with such histories should not use this product.
[July 1997 (Letter) - Schering]
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- Accolate (zafirlukast)
-
The labeling
for the asthma drug Accolate has been revised to
to state that the reduction of the oral steroid dose, in some patients
on Accolate therapy has been followed in rare cases by the occurrence of
eosinophilia,
vasculitic rash, worsening pulmonary symptoms, cardiac complications,
and/or neuropathy sometimes presenting as Churg Strauss Syndrome, a systemic
eosinophilic vasculitis. A causal relationship has not been established.
[July 22, 1997 (Letter) - Zeneca]
[July 23, 1997 (
Talk Paper) - FDA]
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- FDA/CDC Warn Against Blood Donations By Those Possibly Exposed to
Tick-Borne Illnesses
- FDA and CDC advise individuals who underwent training at the Fort Chaffee,
Arkansas
military base during the months of April through June 1997 and have subsequently donated
blood or plasma within four weeks after leaving the base to immediately notify the blood or
plasma establishment where the donation occurred.
[July 18, 1997 (Statement) -
FDA]
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- Recombinant
Human Factor VIII Recalled
- The Hyland Division of Baxter Healthcare is urgently recalling three lots of
Recombinate
because of possible contamination with penicillium, a type of mold.
[July 12, 1997 (Talk Paper)
- FDA]
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- Assays for Antibodies to Borrelia burgdorferi:
Limitations, Use, and Interpretation for Supporting a Clinical Diagnosis of Lyme Disease.
- FDA advises of the potential for misdiagnosis of Lyme disease. The
results of commonly marketed assays
for detecting antibody to the organism that causes Lyme disease may be
easily misinterpreted. A positive result does not necessarily indicate
current infection and
patients with active Lyme disease may have a negative test result. To reduce
this risk
of misdiagnosis FDA provides guidance on the use and interpretation of
these tests. (Click on title above.)
[July 11, 1997 (Public Health Advisory) - FDA]
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- "PHEN/FEN" (phentermine & fenfluramine)
- FDA notifies the medical community of recent reports of valvular
heart disease in women treated for obesity with a combination of fenfluramine and phentermine. There have been 33 cases reported of unusual valvular morphology and regurgitation involving the mitral, aortic, and/or tricuspid valves, usually being multivalvular. The
histopathology of the diseased valves resembled that seen in carcinoid syndrome or ergotamine
toxicity. Six patients have required surgical intervention. Health care practitioners are
reminded that the safety and effectiveness of the combined use of fenfluramine and phentermine have not been established. FDA recommends if practitioners choose to use these products in a manner different than the approved labeling that they should follow patients closely with thorough cardiac evaluations.
[July 8, 1997 (Public Health Advisory) - FDA]
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-
Recall of Blood Products in Six States Due to Risk of Tick-Borne Illnesses
- The FDA advises the public about a voluntary recall of certain blood products collected at
the Fort Chafee, Arkansas, military base because donors of the products may have been
exposed to a tick-borne disese. The recall involves products collected since April 1997. The
following states may have received the recalled blood products (including red blood cells,
platelets,
and recovered plasma): Alabama, Arkansas, Louisiana, Mississippi, Oklahoma, and Texas.
[July 3, 1997 (HHS News) - FDA]
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- Home Abortion &
Female Self-Sterilization Kits
- FDA warns consumers not to purchase or use unapproved home abortion or
female self-sterilization kits that are offered for sale on the internet.
[June 17, 1997 (Talk Paper) -
FDA]
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- Cordarone (amiodarone HCl)
- Wyeth-Ayerst advises that the labeling for the antiarrhythmic agent
Cordarone has been revised to incorporate new information on reports of optic
neuritis and optic neuropathy in patients treated with amiodarone.
[June, 1997 (Letter) - Wyeth-Ayerst]
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- Radiation Protection Devices
- Some shielding products used for radiation protection contain
lead contaminated with small amounts of naturally occurring radionuclides.
Initial evaluations indicate that there is only a very small exposure to
radioactivity from the affected products, and the contaminants are not
transferable to patients, personnel or equipment by ordinary use. Products
identified to date include aprons, gonad shields, and thyroid shields
manufactured after October 1, 1996. FDA recommends radiation protection
medical devices containing lead purchased after October 1, 1996 be surveyed
for radionuclide contamination.
[June 13, 1997 (Public Health Notice) - FDA]
[August 5, 1997 (Update) -
FDA]
[October 16,1997 (Update) - FDA]
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- "Plantain"
Containing Dietary Supplements
- FDA warns against dietary supplement products that may contain
digitalis mislabeled as "Plantain". FDA recently conducted an investigation
on a report where a young woman experienced abnormal heart rate with heart
block after consuming a dietary supplement containing "plantain". Laboratory
analyses confirmed the presence of digitalis.
[June 12, 1997 (Statement) -
FDA]
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- Protease
Inhibitors
- FDA warns that protease inhibitors may contribute to increases in blood sugar and even
diabetes
in HIV patients and recommends close monitoring of glucose levels in these patients.
[June 11, 1997 (Public Health
Advisory) - FDA]
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- Excimer Lasers
- FDA is concerned about the potential for serious injury from
unapproved lasers used in eye surgery
because the manufacturers have failed to show that such lasers are safe and effective
for treating patients.
FDA authorized the seizure of unapproved lasers
made by Photon Data Inc., of Winter Park, FL.
Recently, concern has been heightened by reports of serious eye injuries,
such as permanently
damaged eyesight or temporary blindness requiring a corneal transplant.
[June 9, 1997 (Talk Paper) - FDA]
[October 22, 1997 (Update) - FDA]
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- Ephedrine Dietary Supplements
- FDA proposes to limit the amount of ephedrine alkaloids contained
in dietary supplement products and require labeling and marketing measures that give
adequate warning and information to consumers. Hundreds of illnesses and injuries associated
with the use
of these products have been reported.
[June 2, 1997 (HHS News) - FDA]
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- Total Hip Prostheses
- Steam sterilization has been associated with surface roughening
of zirconia ceramic femoral head components of total hip
prostheses, which can cause premature failure and require early revision.
FDA cautions against using steam sterilization if these
devices require re-sterilization because the package has
been damaged or opened.
[June 2, 1997 (Letter) - FDA]
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- Chomper
- The FDA warns of potentially life-threatening heartblock associated with
the use of the dietary supplement Chomper distributed by
Arise & Shine of Mount Shasta, CA. Consumers are warned not to purchase or consume
this product.
[May 16, 1997 (HHS News) - FDA]
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- Reusable Devices
- The FDA's Center for Devices and Radiological Health warns of a potential infection
problem with medical devices that are rented or leased by health care facilities.
Recommendations are
provided to help ensure that reusuable (nondisposable) medical devices rented or
leased from third parties are properly cleaned, disinfected and/or sterilized.
[April 17, 1997 (Letter) - FDA]
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- Sucostrin
(succinylcholine)
- Bristol-Myers Squibb calls attention to two life-threatening events
that may occur with the use of succinylcholine:
CARDIAC ARREST IN CHILDREN AND
ADOLESCENT PATIENTS RECEIVING SUCCINYLCHOLINE -
There have been several reports of cardiac arrest following administration
of succinylcholine to apparently healthy children and adolescent
patients who were subsequently found to have undiagnosed
myopathies. Because children and adolescent patients are more likely than
adults to have such undiagnosed myopathies, a non-depolarizing neuromuscular blocking
drug should be used for routine elective surgery in these patients.
SUCCINYLCHOLINE-INDUCED HYPERKALEMIA -
Except when used for emergency tracheal intubation or in instances
where immediate securing of the airway is necessary,
succinylcholine is contraindicated in patients after the acute phase of
injury following major burns, multiple trauma, extensive denervation of
skeletal muscle, or upper motor neuron injury because succinylcholine
administration to such individuals may result in severe hyperkalemia
which may result in cardiac arrest. The risk of hyperkalemia in these
patients increases over time and usually peaks at 7 to 10 days after
the injury. The risk is dependent on the extent and location of the injury.
The precise time of onset and the duration of the risk period are not
known.
[April 3, 1997 (Letter) - Apothecon]
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- Lamictal
- New warnings in the labeling for the antiepileptic Lamictal
(lamotrigine) pertain to
reports of severe, potentially life-threatening rash, including
Stevens-Johnson syndrome, and rarely, toxic epidermal necrolysis,
reported in association with the use of Lamictal. A boxed warning
emphasizes that Lamictal is not indicated for use in
patients below the age of 16 years. Reports from clinical
trials suggest that as many as 1 in 50 to 1 in 100 pediatric patients
treated with Lamictal develop a potentially life-threatening rash,
as compared with a rate of approximately one in every thousand adults.
Prior to initiation of treatment with Lamictal, the patient should be
instructed that a rash or other signs or symptoms of
hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious
medical event and that the patient should report any such occurrence
to a physician immediately.
[March 1997 (Letter) - Glaxo Wellcome, Inc.]
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- Devices
for Direct Detection of Group B Streptococcal Antigen
- FDA alerts health professionals of potentially fatal misdiagnoses when
using test
kits to detect group B streptococcal (GBS) antigen, and provides guidelines
on how to
appropriately use these tests. Antigen tests for GBS have produced false
negative
results from specimens from pregnant women and infants with subsequent
infant deaths
from GBS disease. These tests have also produced false positive results which
may lead to inappropriate antibiotic therapy and prolonged hospitalization.
Clinicians
need to understand the limitations of these devices. Antigen tests are an adjunct to
diagnosis and are NOT an appropriate substitute for properly performed bacterial culture
in the diagnosis of GBS.
[March 24, 1997 (Safety Alert) - FDA]
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- Infant Formula (Homemade)
- There may be serious safety concerns about the use of a homemade
infant formula based on a recipe from two doctors in Shippensburg, PA.
Prolonged use of the formula, particularly if the formula is used as
the sole source of nutrition, could be hazardous to the health of an infant.
Among the concerns are hypochloremia, hypokalemia, hypermanganesemia,
metabolic acidosis, vitamin deficiencies, and failure to thrive.
[February 26, 1997 (Letter) - FDA]
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- Gamma Hydroxybutyric Acid (GHB)
- FDA re-issues warning against the use of GHB, a chemical
that has been promoted as a steroid alternative for body building
and other uses for several years. Recently it has gained favor as a
recreational
drug because of its intoxicating effects. Numerous cases of
GHB-related illness have been reported. Symptoms include vomiting,
dizziness, tremors and seizures. Many of those injured required
hospitalization, and some deaths have been linked to the use of GHB.
GHB is NOT approved for sale as a medical product in the U.S.
[February 18, 1997
(Talk Paper) - FDA]
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- Paremyd
-
The company advises that three serious
adverse events have recently occurred following the use of Paremyd
(hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution). The three
events
included 1 - fatal myocardial infarction, 2 - ventricular fibrillation, and 3 -
hypotension, bradycardia, and syncope. Health professionals are reminded that
Paremyd combines both sympathomimetic and parasympatholytic agents and that all
such compounds have known potential effects on the cardiovascular system.
The known pharmacology of
these compounds should be kept in mind when using them.
[February 7, 1997 (Letter) - Allergan]
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- Pondimin
-
The product labeling for Pondimin (fenfluramine HCl)
has been revised to convey the final evaluation of the
International Primary Pulmonary Hypertension Study.
PONDIMIN IS AN APPETITE SUPPRESSANT,
AND APPETITE SUPPRESSANTS INCREASE THE RISK OF DEVELOPING
PRIMARY PULMONARY HYPERTENSION (PPH), AN OFTEN
FATAL DISORDER.
Use of appetite suppressants for longer than 3 months is associated with a
23-fold increase
in the risk of developing PPH.
Therefore, the risk associated with the long-term use of appetite
suppressants is estimated to be about
23 to 46 cases per 1 million persons per year.
Pondimin is contraindicated in patients with glaucoma, in patients
with hypersensitivity to
fenfluramine
or related agents, and in patients taking (or within 14 days of
discontinuing)
an MAO inhibitor. This drug should not be used by patients with a
history of drug abuse, nor in those patients with
alcoholism or psychotic illness.
Potent anesthetic agents should be administered with caution in patients
taking Pondimin and other CNS-depressant drugs should be used with caution.
Pondimin is not
recommended for pregnant or lactating women or for pediatric patients.
The maximum recommended dose (120mg/day) should not be exceeded. Concomitant
use of Pondimin
with other weight-loss agents is not recommended. The use of
phentermine and fenfluramine ("fen/phen") concomitantly is not
an approved use of Pondimin.
[January 1997
(Letter) - Wyeth-Ayerst Laboratories]
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- Seldane
- FDA proposes to withdraw the approval of Seldane (terfenadine),
Seldane D (terfenadine and pseudoephedrine) and generic versions of the prescription
antihistamine. Fexofenadine, the primary active derivative of terfenadine, is now
available as the prescription product Allegra. Fexofenadine provides nearly all of
terfenadine's beneficial effects but, unlike terfenadine, does not appear to cause
a potentially fatal heart
condition when taken with some other commonly prescribed medications. FDA
has therefore
determined that drugs containing terfenadine are no longer shown to be safe
because fexofenadine is now available.
[January 13, 1997 (Talk Paper) - FDA]
01/14/97: Federal Register, Vol. 62, No. 9, pg. 1889 - 1892.Hoechst Marion Roussel, Inc.,
and Baker Norton Pharmaceuticals, Inc.;
Terfenadine; Proposal To Withdraw Approval of Two New Drug Applications and
One Abbreviated New Drug Application; Opportunity for a Hearing.
[Docket No. 96N-0512].
(TEXT format or
PDF
format)
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- Ventritex Cardioverter/Defibrillator
-
In two instances, it has been determined that failure of the crystal oscillator in the Ventritex
Cadence V-110 and V-112 series devices may disrupt critical timing sequences and result in
erroneous values being written to the microprocessor in the device. This has caused loss of the
devices's
serial number and resulted in inappropriate therapy parameters,
specifically rapid bradycardia pacing, which may lead to the induction of
potentially lethal ventricular tachyarrhymias.
[January 1997 (Letter) - Ventritex]
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