Four Pfizer Medications On FDA Watch List
Four Pfizer Medications On FDA Watch List: Inclusion indicates need for more study [The Day, New London, Conn.]
From Day, The (New London, CT) (July 7, 2010)
July 07--FOUR PFIZER INC. DRUGS -- Zithromax, Zmax, Torisel and Premarin -- have shown up on a first-quarter watch list of 13 medications currently targeted for extra scrutiny by the U.S. Food and Drug Administration.
None of the Pfizer drugs had appeared in the previous quarter’s watch list, which contained only seven medications. A drug’s appearance on the list doesn’t mean it is unsafe; it simply indicates a need to gather more information about possible side effects, the FDA said.
The watch list is compiled from reports sent in by patients and doctors through the FDA’s Adverse Event Reporting System.
"The listing of a drug and a potential safety issue ... does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication," according to the agency’s website. "Patients who have questions about their use of the identified drug should contact their health care provider."
The antibiotic Zithromax, which Pfizer’s Groton laboratories had a hand in developing, is being studied, along with the Abbott Laboratories antibiotic Biaxin, for potentially causing liver failure in a small minority of patients. A related Pfizer antibiotic formulation, Zmax extended release 2 g, has been tied to a stomach condition known as pyloric stenosis that causes severe vomiting, according to the FDA Medication Watchlist released last week.
Pfizer’s estrogen therapy Premarin, which the company acquired in its merger with Wyeth Pharmaceuticals, also made the watch list because of reports that patients experienced swelling just below the skin.
Torisel, a medicine targeting advanced kidney cancer and another Pfizer drug acquired in the Wyeth deal, is being investigated for reports of pain and discomfort at the injection site.
It is unclear why Pfizer drugs represent nearly a third of all medicines on the latest FDA watch list. But the FDA earlier this year sent Pfizer a strongly worded letter charging that it has been lax in reporting serious side effects from drugs already on the market.
Other drugs on the new list and the companies that market them are chemotherapy therapy Vidaza (Celgene), anti-coagulent Effient (Eli Lilly), anti-inflammatories Cinryze (ViroPharma Biologics) and Berinert (CSL Behring), antibiotic Cubicin (Cubist Pharmaceuticals), heart medications Multaq (Sanofi-Aventis) and Ranexa (Gilead) and narcolepsy drugs Provigil (Cephalon) and Xyrem (Jazz Pharmaceuticals).
Dangers associated with these drugs ranged from congestive heart failure (Multaq) to convulsions (Provigil, Xyrem). Further information is available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm216272.htm.
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Posted: July 2010