The U.S. Food and Drug Administration intends to add firm
warnings about suicidal behavior on the labels of 11 epilepsy medications, as
indicated by files posted on the organization’s Web site.
The FDA will require companies to bring the drugs’ labels up
to date, in order to include black-box warnings, the most severe warnings the
agency releases. The proposition will be assessed by external consultants at a conference
held on Thursday in Beltsville,
Md.
The board of outside specialists is due to review the
dangers produced by the drugs that treat epilepsy, a disease indicated by
convulsions that can cause unconscious movement or unintentional actions.
Transactions of epilepsy medications, regularly prescribed
in order to remedy psychiatric disorders, surpassed $10.2 billion in the United States
last year. The FDA’s investigation upon almost 200 studies discovered that 0.43
percent of the patients who were taking the drugs committed suicide or at least
had such intentions, compared with 0.24 percent of patients on a placebo. Drug manufacturers
and examiners argued the findings, saying that it is erroneous to mingle statistics
made upon medicines that have different roles.
The group of outside advisers to the agency is programmed to
decide how to publicize the risks that were first disclosed by the FDA in a
January 31 notification to healthcare suppliers.
The major epilepsy drugs sellers were J&J’s Topamax and
Glaxo’s Lamictal, each holding 21 percent of the market, as said by the
research firm IMS Health Inc. Other well-known products included in the FDA’s
analysis are Pfizer Inc.’s
Neurontin and Lyrica, Meda AB’s Felbatol, UCB SA’s Keppra, sold by
several drug manufacturers.
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