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:

Chomper
Ephedrine Dietary Supplements
Gamma Hydroxybutyric Acid (GHB)
"Herbal Fen-Phen" (Posted: 11/6/97)
Infant Formula (homemade)
"Plantain" Containing Dietary Supplements

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Biologics:

Recombinate
Blood Donations
Blood Recall

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Medical Devices:

Devices for Direct Detection of Group B Streptococcal Antigen
Excimer Lasers (Updated: 10/22/97)
Home Abortion & Female Self-Sterilization Kits
Home-Use Test Kits
Lyme Disease Assays
Radiation Protection Devices(Updated: 10/16/97)
Reusable Devices
Total Hip Prostheses
Toxoplasma IgM Commercial Test Kits
Vacuum Loss in Electronic Resonating Components
Ventritex Cardioverter/Defibrillator

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Other Products:

Laser Pointers (Posted: 12/18/97)

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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]

"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]

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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