Professional Documents
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Pharmabites - 10-29-07
Pharmabites - 10-29-07
Volume 1 Number 35
Brought to you by Thomas Jefferson University’s Department of Health Policy
FDA: Might Seek Warning on Avandia Label for Heart Attack Risk
FDA might ask GlaxoSmithKline to add a new black box warning to the label of the type 2
diabetes medication Avandia related to increased risk for heart attacks associated with the
treatment, according to individuals familiar with discussions between the agency and GSK. The
Avandia label currently includes a black box warning related to increased risk for heart failure
associated with the medication (Wall Street Journal, 10/24; AmericanHealthLine, 10/24)
FDA: Panel Urges Ban on OTC Cold Treatments for Younger Children
An FDA advisory panel on Friday voted 13-9 to recommend that the agency ban the sale of over-
the-counter cough and cold medicines for children younger than age six, the New York Times
reports. Members voted 21-1 that the products should be banned for children younger than age
two (New York Times, 10/20). The panel by a 15-7 vote decided against a similar
recommendation on use of the drugs for children ages six to 11, according to the Washington
Post. The decisions also include antihistamines for treatment of allergies. FDA is not required to
act on the recommendations, but agency officials said they would review the panel's work and
formulate the necessary steps to address the issues raised (Washington Post, 10/20)
(AmericanHealthLine, 10/22).