UPDATE: FDA Says Abbott's Depakote Promotion Is Misleading
30 Janvier 2009 - 7:30PM
Dow Jones News
Federal regulators have sent a letter to Abbott Laboratories
(ABT) warning the company that promotional material for the
anti-epilepsy drug Depakote is misleading because it omits
important risk information.
Flashcards for Abbott's Depakote are misleading because they
suggest the drug is safer than demonstrated, according to a letter
the U.S. Food and Drug Administration sent on Jan. 22 to
Illinois-based Abbott. The letter was posted on the FDA's Web site
Thursday evening.
The FDA wants Abbott to remove the flashcards from the public
and describe to the agency by Feb. 6 how it plans to do so.
Abbott has removed the flashcards, which were distributed to
health-care providers, from circulation and plans to respond to the
FDA by Feb. 6, said company spokeswoman Raquel Powers.
Depakote, approved in 1983, is used to treat manic episodes in
people with bipolar disorder, and for patients with seizures. The
drug's label has been changed more than six times to include, among
other things, updated information about safety risks associated
with the product.
The FDA said the flashcard doesn't include any risk information
on the body. The agency said a statement on the front of the
flashcard that refers people to important warnings on the reverse
side is in small type and doesn't "mitigate this misleading
presentation."
The Depakote warning letter comes about a month after Abbott
received a warning letter for an advertisement for its psoriasis
drug Humira. In December, the agency said an ad for Humira is
misleading and makes claims not supported by scientific
evidence.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com
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