A watch list of 13 drugs based on potential signs of serious risks or new safety information collected by the Adverse Event Reporting System (AERS) of the US Food and Drug Administration (FDA) during the first quarter of 2010 has been released.
The FDA is studying all of the drugs to determine the need for any regulatory action.
A drug’s appearance on the watch list does not mean the agency has determined that the drug poses the health risk in question. Physicians should not stop prescribing the drug, and patients should not stop taking it, according to the FDA.
The FDA is evaluating 2 antibiotics — azithromycin (Zithromax; Pfizer) and clarithromycin (Biaxin; Abbott) — to find out whether they are associated with liver failure. Suspicions about azithromycin and liver failure are not new. The label for the antibiotic states that adverse events discovered after the drug entered the marketplace — and for which a causal relationship may not be established — include “abnormal liver function including hepatitis and cholestatic jaundice, as well as rare cases of hepatic necrosis and hepatic failure, some of which have resulted in death.” During clinical trials, cholestatic jaundice was a rarely reported adverse effect.
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