News Briefs: FDA posts drug warnings, labeling changes
May 1, 2002
News Briefs: FDA posts drug warnings, labeling changes
The Food and Drug Administration (FDA) recently posted warnings on its MedWatch web site about several drugs. They are:
• FDA and Bristol-Myers Squibb have notified health care providers caring for persons with HIV of the potential for lactic acidosis as a complication of therapy with stavudine (Zerit), d4T. The early signs and symptoms of clinical events associated with hyperlactatemia should receive careful attention because of the life-threatening potential of the most extreme manifestation, lactic acidosis syndrome.
Bristol-Myers Squibb has received reports of rare occurrences of rapidly ascending neuromuscular weakness, mimicking the clinical presentation of Guillain-Barré syndrome (including respiratory failure), in HIV-infected patients receiving stavudine in combination with other antiretrovirals. Some cases were fatal. If motor weakness develops in a patient receiving stavudine, the drug should be discontinued.
For more information, see www.fda.gov/medwatch/SAFETY/2002/safety02.htm#zerit.
• FDA and Aventis strengthened the Warnings and Precautions sections of the enoxaparin sodium (Lovenox) prescribing information to inform health care professionals that the use of enoxaparin sodium Injection is not recommended for thromboprophylaxis in patients with prosthetic heart valves. New post-marketing safety information concerning congenital anomalies and non-teratogenic effects on pregnant women and fetuses also is described.
For more information, see www.fda.gov/medwatch/SAFETY/2002/safety02.htm#loveno.
• The labeling for ziprasidone HCl (Geodon) capsules has been clarified. The revisions, made in consultation with FDA, clarify information that already had been included in the package insert. The Contraindications section included a list of seven drugs contraindicated with ziprasidone and stated that this list of drugs was "not a complete list." However, not all physicians, pharmacists, and pharmacy databases interpreted this language as intended. Some may have considered certain drugs excluded from the contraindication, while others believed that, irrespective of the level of documentation, any drug associated with QT-prolongation was contraindicated with ziprasidone. Pfizer and FDA agreed there was a need to provide greater clarity around the particular drugs or types of drugs that are contraindicated with Geodon. For more information, see www.fda.gov/medwatch/SAFETY/2002/safety02.htm#geodon.
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