Chantix, Xenical still under FDA probe

FDA aired its quarterly laundry list of drug-safety probes yesterday, reminding us--and everyone else--of its ongoing investigations. Nineteen drugs made the list, several with multiple brand names. Some of those meds won't be on the next quarterly list, because the agency and drugmaker added warnings to their labels or otherwise resolved the issue. Examples include Merck's HIV med Isentress [1], which got a label update to highlight a risk of psychiatric events, and GSK's migraine remedy Treximet, which got a warning on heart attack risks.

Many, however, got the following verdict: "FDA is continuing to evaluate this issue to determine the need for any regulatory action." Among them are Pfizer's smoking-cessation remedy Chantix [2], which has attracted attention for reports of psychiatric side effects; the latest adverse events listed for the drug include "serious" skin reactions, visual impairment, and accidental injury. Then there's the GlaxoSmithKline/Roche weight-loss drug Xenical and its OTC form Alli [3]. The agency is still looking at reports of liver toxicity related to those two meds. Check the list [4] for more.

It's important to note that just because a product makes this list doesn't mean there's a proven, causal link between the drug and the reported side effects. That's why FDA is studying them--to look for evidence of a link. The jury's still out.

- see the FDA report [4]
- read the story [5] from Dow Jones

Related Articles:
U.K.: 10 Champix users commit suicide [6]
Pfizer puts Chantix back on TV [7]
GSK taps Wynonna to pitch Alli [8]
FDA chiefs: We're for public health [9]