|
The U.S. Food and Drug Administration (FDA) panel finally
unanimously disapproved acomplia, a weight loss drug manufactured
by Sanofi-Aventis, after month's long speculation on the issue
on June 13th. The major evidence against this decision came
out in the form of report prepared by the advisory panel for
the meet. The decision is solemnly based on the concerns pertaining
to the safety of weight
loss drug acomplia.
An FDA spokeswoman said that "the discussions of the
panel finally boiled down to the conclusion that the risk
is not worth the benefit bestowed by the drug, and thus the
panel replied in negative".
The FDA will take a final decision on French drug maker's
appeal for acomplia's sale in the United States in late July.
"Traditionally, the FDA observes the recommendations
of its advisory committee while taking up any approval decision"
the spokeswoman articulated.
Paris-based Sanofi-Aventis's preparation got defeated by
the vote difference of 14-0. Yet, the maker declared late
Wednesday that it "will not discontinue its association
with the FDA and will work to address the committee's suggestions."
In its report released on Wednesday, the advisory panel raised
a number of concerns over the safety of Acomplia, especially
in reference to its impact on consumer's psychological health.
To get its product duly reviewed by the panel, Sanofi-Aventis
provided data and analyses on the drug late last year.
According to the panel's report, "Adverse events noticed
while the drug's clinical trials includes depressive events,
anxiety, sleep disorders, and psychomotor agitation"
The FDA's Division of Metabolism and Endocrine Products has
also encountered a line of reports related to the side effects
of the drug. According to the estimate of panel's report,
"4 reports of delusional symptoms, 5 reports of aggression
and 6 reports of psychotic behavior have been reported so
far"
A generic form of acomplia, Rimonabant is accepted in 37
countries and is readily marketed in 18 countries, according
to the French drug maker Sanofi-Aventi.
|
