Friday, August 27, 2010

FDA's Q2 2010 "Safety Concerns" List Is Out -- Merck's Implanton® Is A New Addition

Several Merck products have been on this list over the past few years (msot notably, Vioxx®), but Implanton® is new this quarter. Here's a direct link to the FDA's full Q2 2010 Safety Concerns list page.

Thanks to Reuters, we were alerted to the Merck angle in this story, earlier this afternoon:

. . . .The list, which comes out quarterly, covers safety issues that the FDA flagged between April and June. . . .

[D]rugs listed include Merck's birth control Implanon®. . . .

In most cases, the FDA offered few clues into what the concerns were and simply said the agency "is continuing to evaluate this issue to determine the need for any regulatory action."

Merck's cholesterol drug Zocor®. . . [was] also listed [along with others], but the agency has already issued more specific safety alerts on those drugs. . . .

We'll keep you posted.

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