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New Safety Information Summaries
1996
Summaries of "Dear Health Professional" letters and other safety notifications of which MedWatch is aware. Listed in reverse chronological order.Current as of: January 17, 1997
Quick Reference:
(Click on name of the product to go directly to the summary.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 name in the summary.)
Adrenal Cortex Extract - Albuminar and Plasma Plex - Antihemophilic Factor - Catheters (Midline) - Cellulose Acetate Dialyzers - Cylert - Eldepryl - Ephedrine (Botanical) - Fosamax - Gloves (Examination) - Glucophage - Halcion and Xanax - Hismanal - Lindane - Measles Vaccine - Norvir - Oxycontin and MS Contin - Phenylpropanolamine - Protease Inhibitors - Redux - Redux (cont'd) - Seldane - Trancopal - Ultram - Vistide
- Eldepryl (selegiline HCl)
-
The product labeling for Eldepryl has been modified to note that,
although rare, a few reports of hypertensive reactions associated with ingestion of tyramine
containing foods have occurred in patients receiving Eldepryl at the recommended dose (5mg
bid). To date, two reports have been received. An additional case of hypertensive reaction in a
patient on the recommended dose of selegiline taking several concomitant drugs is described in
the article "Pseudo-phaeochromocytoma after multiple drug interactions involving the selective
monoamine inhibitor selegiline" (Clinical Endocrinology 1995;42:95-99). The risks of
hypertensive events significantly increase when patients are exposed to doses higher than the
labeled dose regimen. Careful monitoring is required for patients who are prescribed Eldepryl in
doses exceeding 10 mg per day and for those patients who are transferred from one selegiline
preparation to another.
[December 23, 1996 (letter) - Somerset Pharmaceuticals, Inc.]- The product labeling for Cylert has been modified to include a boxed warning describing liver failure and to indicate that Cylert should not ordinarily be considered as first line drug therapy for Attention Deficit Hyperactivity Disorder (ADHD). Since Cylert's marketing in 1975, 13 cases of acute hepatic failure have been reported to the FDA. While the absolute number of reported cases is not large, the rate of reporting ranges from 4 to 17 times the rate expected in the general population. This estimate may be conservative, as underreporting and possible limitations on recognizing the Cylert-hepatic failure association due to long latency may lead to only a portion of actual cases being identified and reported. Thus, the risk could substantially higher. Of the 13 reported cases, 11 resulted in death or liver transplantation, usually within four weeks of the onset of signs and symptoms of liver failure. The earliest onset of hepatic abnormalities occurred six months after initiation of Cylert. Although some reports described dark urine and nonspecific prodromal symptoms (e.g., anorexia, malaise, and gastrointestinal symptoms), in other reports it was not clear if any prodromal symptoms preceded the onset of jaundice. It is also not clear if the recommended baseline and periodic liver function testing are predictive of these instances of acute liver failure. Cylert should be discontinued if clinically significant hepatic dysfunction is observed during its use.
[December 1996 (letter) - Abbott Laboratories]- The product labeling for Redux has been modified to reflect the information communicated to Health Care Professionals in the August 1996 letter from Wyeth-Ayerst Laboratories. "Important Patient Information" sheets are available from the company (1-800-934-5556) to aid in counseling patients as to the risks and benefits of Redux therapy. Health Care Professionals are reminded that REDUX 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. Based on a 2-year case-control study, 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. Redux should not be used in patients with hypersensitivity to dexfenfluramine or related compounds or in patients with diagnosed pulmonary hypertension. Redux should not be used concomitantly with an MAO inhibitor or within 14 days of discontinuation. Redux should not be taken in combination with other selective serotonin reuptake inhibitors. Redux in not recommended for pregnant or nursing women or people under 18 years of age.
[December 1996 (letter) - Wyeth-Ayerst Laboratories]- CDC and FDA are investigating a recent occurrence involving serious patient injury following hemodialysis treatment. Within 24 hours of treatment, seven patients who received in-patient dialysis using cellulose acetate dialyzers developed one or more of the following symptoms: conjunctivitis, visual loss, and hearing loss. The investigation should be completed within the next several months. In the meantime, due to potential adverse effects of storing cellulose acetate dialyzers at warm temperatures or over long periods of time, it is recommended that dialysis stock be rotated using "first-in-first-out" practices.
[December 16, 1996 (letter) - FDA/CDC]- Based on postmarketing experience, the Norvir Product Information has been updated to reflect new information about drug interactions. Ergot alkaloid preparations and pimozide have been added as contraindications. Cardiac and neurologic events have been reported with coadministration of disopyramide, mexiletine, nefazadone, or fluoxetine. Saquinavir plasma concentrations increased greater than 20-fold when coadministered with ritonavir 400 mg and 600 mg b.i.d. dosing regimens. However, the appropriate doses for this combination, with respect to activity and safety, have not been established.
Additionally, the WARNING and ADVERSE REACTION sections have been revised to include information regarding allergic reactions, hepatic transaminase elevations and postmarketing reports of hepatic dysfunction, seizure, hyperglycemia, syncope, orthostatic hypotension and renal insufficiency. Also, the PRECAUTIONS and OVERDOSAGE sections have been updated. Also included is a review of the importance of dose titration upon the initiation of Norvir therapy to reduce treatment-emergent adverse events while maintaining appropriate plasma levels.
[November, 1996 (letter) - Abbott Laboratories]- Sanofi Winthrop is discontinuing Trancopal worldwide. A recent retrospective European inquiry confirmed the low incidence of serious cutaneous reactions (toxic epidermal necrolysis) associated with the use of chlormezanone.
[November 7, 1996 (letter) - Sanofi Winthrop]- There have been several reports of severe renal impairment associated with the use of Vistide. Guidelines are provided that reinforce the importance of appropriate patient selection,treatment administration and monitoring therapy in order to ensure that Vistide is used safely and to alert prescribers about two new contraindications (preexisting renal disease and concomitant administration with agents having nephrotoxic potential).
[September, 1996 (letter) - Gilead Sciences, Inc.]- Albuminar and Plasma Plex Recall
- Centeon announced a voluntary recall of all in-date lots of Albuminar and Plasma Plex which expire prior to September 30, 1999. No other Centeon products are affected by this voluntary action. Centeon is taking this action as a precaution due to manufacturing concerns related to these two products. For more information call Centeon at (800) 551-0120.
[October 9, 1996 (announcement) - Centeon]- Antihemophilic Factor (Factor VIII)
Recall- One lot of antihemophilic factor, Lot P72304, is being recalled by Centeon. The product may have been damaged as a result of a manufacturing problem creating a risk for contamination. No illnesses associated with this product lot have been reported to FDA, but the lot has been recalled as a precautionary measure.
[October 4, 1996 (talk paper) - FDA]- Glucophage
(metformin HCl)- Letter reinforcing the importance of appropriate patient selection in order to minimize the risk of lactic acidosis. The risk of lactic acidosis with Glucophage therapy can be minimized by avoiding its use in patients at risk for significant drug accumulation (e.g. renal impairment) or in patients at an increased risk for developing lactic acidosis independent of therapy because of impaired ability to clear lactate (e.g. conditions associated with tissue hypoperfusion or hypoxic states, or substantial liver impairment). There are also clinical circumstances under which Glucophage therapy should be withheld or discontinued: patients with evidence of renal disease or dysfunction, prior to procedures using intravenous iodinated contrast media, acutely ill patients and/or those who are hemodynamically unstable, and patients with impaired hepatic function or excessive alcohol intake.
[September 11, 1996 (letter) - Bristol-Myers Squibb]- Injectable Adrenal Cortex Extract
- At least 54 cases have been reported in the US of abscess formation at injection sites where patients have received adrenal cortex extract (30 ml vials) distributed by Phyne Pharmaceuticals. Adrenal cortex extract is not approved for use by FDA for any indication, but the product has been promoted for a wide variety of uses including weight loss, burn treatment and lessening substance abuse addictions. Physicians or consumers with adrenal cortex extract products bearing "Hallmark Labs" on the label should immediately stop using the product and contact FDA.
[August 30, 1996 (alert) - HHS News]Prelimary findings were summarized in the August 23, 1996 MMWR article " Infection with Mycobacterium abscessus Associated with Intramuscular Injection of Adrenal Cortext Extract--Colorado and Wyoming, 1995-1996
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files- Prescribing information has been changed to indicate that triazolam and alprazolam are metabolized via the cytochrome P450 3A (CYP 3A) pathway and may interact with other drugs and foods that use this pathway. Halcion is contraindicated with ketoconazole, itraconazole, and nefazodone, medications that significantly inhibit oxidative metabolism mediated by CYP 3A. Xanax is contraindicated with ketoconazole and itraconazole.
[August 23, 1996 (letter) - Pharmacia & Upjohn]- Prescribing information is being updated to be consistent with the final report of the International Primary Pulmonary Hypertension Study which looked at the relationship between anorexigens and primary pulmonary hypertension. Patients should be advised to report immediately any deterioration in exercise tolerance, and treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope, or lower extremity edema. Redux should not be used in patients hypersensitive to dexfenfluramine or related compounds; in patients with diagnosed pulmonary hypertension; or in patients taking (or within 14 days of discontinuing) monamine oxidase inhibitors.
[August 22, 1996 (letter) - Wyeth-Ayerst Laboratories and Interneuron Pharmaceuticals, Inc.]- FDA and the drug manufacturers recommend that health care providers monitor hemophiliac patients for spontaneous bleeding episodes whenever any of the protease inhibitors is used as part of treatment for HIV. There are three HIV protease inhibitors currently approved for marketing in the U.S. for the treatment of HIV infection: INVIRASE, (saquinavir), NORVIR, (ritonair) and CRIXIVAN, (indinavir).
[July 17, 1996 (letter) - FDA]- Concern over the potential for fires involving powder-free latex patient examination and glove quality during warehouse storage. FDA provides several recommendations including powder-free latex patient examination gloves should not be stored in conditions of extreme heat, and cartons should be stacked to facilitate cooling ventilation.
[June 27, 1996 (Public Health Advisory) - FDA]- Oxycontin (Oxycodone HCl controlled-release) and MS Contin (Morphine sulfate controlled-release)
- An urgent notice to discard all dosage conversion slide card calculators for both products at once. A small but unknown number of the slide card conversion calculators were not correctly cut. A misaligned reading could cause the recommended conversion dose to be potentially toxic in a very small number of patients. The company has distributed new dosage conversion calculators, and additional copies are available by calling (203) 853-0123.
[June 14, 17996 (letter) - Purdue Pharma L.P.]- Two recent studies published in JAMA suggest that the concomitant use of Seldane/Seldane-D and macrolide antibiotics or azole antifungal agents still exists. A reminder that Seldane/Seldane-D is contraindicated in patients taking ketoconazole, itraconazole, erythromycin, clarithromycin or troleandomycin, or in patients with significant hepatic dysfunction. Concomitant use may result in serious cardiovascular events, including death, cardiac arrest, torsades de pointes and other ventricular arrhythmias.
[June 1996 (letter) - Hoechst Marion Roussel]- Street Drugs Containing Botanical Ephedrine
- FDA is warning consumers not to purchase or consume ephedrine-containing dietary supplements with labels that often portray the products as apparent alternatives to illegal street drugs such as "ecstasy." Possible adverse effects of ephedrine range from clinically significant effects such as heart attack, stroke, seizures, psychosis and death, to clinically less significant effects that may indicate the potential for more serious effects (for example, dizziness, headache, gastrointestinal distress, irregular heartbeat, and heart palpitations).
[April 10, 1996 (press release) - FDA]- Lindane-Containing Lice Treatments
- Lindane is generally safe and effective when used according to the approved directions, but its overuse can be harmful. FDA has recommended labeling changes that encourage lindane's use only for patients who have either failed to respond to adequate doses, or are intolerant of, other approved therapies. In addition, lindane products' labeling will advise health care providers and parents not to confuse prolonged itching with reinfestation. The drug's label already warns parents that neurotoxicity is a possibility among certain patients, especially infants.
[April 3, 1996 (talk paper) - FDA ]- The administration of quinine (doses of 430 mg or higher) is now contraindicated with Hismanal. This is based on pharmacokinetic data and case reports which indicate that this agent may alter the pharmacokinetic parameters of astemizole, which may result in elevated plasma levels of astemizole and desmethylastemizole which is accompanied by electrocardiographic QT prolongation. Product labeling has been revised to include this information.
[March 25, 1996 (letter) - Janssen]- Prescribing information has been updated regarding the potential for abuse, seizures, and anaphylactoid reactions. This information is based on experience obtained from the use of Ultram for the treatment of moderate to moderately severe pain in an estimated five million patients in the United States.
[March 20, 1996 (letter) - Ortho-McNeil Pharmaceutical]- There are a number of case reports of esophagitis and esophageal ulceration in patients taking Fosamax. In a large proportion of cases reported, there is evidence that Fosamax was not dosed in the manner recommended in the Product Circular (for example, patients were taking Fosamax with little or no water, taking it at bedtime and/or lying down within minutes after taking it, etc). Merck has revised the Product Circular (and Patient Package Insert) to advise strict compliance with the dosing instructions.
[March 15, 1996 (letter) - Merck & Co., Inc.]- FDA proposes additional warnings that will advise consumers not to take a PPA-containing drug with any other product that contains PPA, phenylephrine, pseudoephedrine or ephedrine. The proposed labeling would also require that PPA-containing weight control products be used by adults only (i.e., over 18 years of age).
[February 14, 1996 (talk paper) - FDA]- The article is a summary of VAERS data reviewing 55 cases of thrombocytopenia after measles immunization in the United States. This report shows that severe thrombocytopenia with platelet counts of less than 20,000 per cubic mm may occur in children and adults 1-40 years of age, and may on rare occasions result in severe gastrointestinal or pulmonary bleeding. Thrombocytopenia has been reported to reoccur with the second dose of vaccine.
[January 1996 (journal publication) - The Pediatric Infectious Disease Journal 1996;15(1):88-90 - FDA Staff (Boyce, T, Pemberton, A, and Addiss, D)].- Onset of Adverse Patient Responses during the Placement of Landmark Midline Catheters
- Reports have been received of adverse events either during or within 30 minutes of the placement and flushing of the Landmark Midline Catheter. These events range from minor signs and symptoms to rare life-threatening incidents. The frequency of reports is such that health professionals should be prepared to initiate appropriate medical intervention if an adverse event occurs.
[January 12, 1996 (letter)- Menlo Care, Inc.] - The product labeling for Cylert has been modified to include a boxed warning describing liver failure and to indicate that Cylert should not ordinarily be considered as first line drug therapy for Attention Deficit Hyperactivity Disorder (ADHD). Since Cylert's marketing in 1975, 13 cases of acute hepatic failure have been reported to the FDA. While the absolute number of reported cases is not large, the rate of reporting ranges from 4 to 17 times the rate expected in the general population. This estimate may be conservative, as underreporting and possible limitations on recognizing the Cylert-hepatic failure association due to long latency may lead to only a portion of actual cases being identified and reported. Thus, the risk could substantially higher. Of the 13 reported cases, 11 resulted in death or liver transplantation, usually within four weeks of the onset of signs and symptoms of liver failure. The earliest onset of hepatic abnormalities occurred six months after initiation of Cylert. Although some reports described dark urine and nonspecific prodromal symptoms (e.g., anorexia, malaise, and gastrointestinal symptoms), in other reports it was not clear if any prodromal symptoms preceded the onset of jaundice. It is also not clear if the recommended baseline and periodic liver function testing are predictive of these instances of acute liver failure. Cylert should be discontinued if clinically significant hepatic dysfunction is observed during its use.
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