FDA to seek removal of several cold, diet drugs from stores

ATLANTA (CNN) -- Citing a possible increase in the risk of stroke, the Food and Drug Administration is expected to seek on Monday the removal of several over-the-counter cough, cold and diet drugs from stores.

FDA officials believe that phenylpropanalomine, or PPA, contained in the drugs -- including Triaminic, Contac and Dexatrim -- could enhance the risk of stroke in some people, sources told CNN.

PPA -- an ingredient in hundreds of medications including Alka-Seltzer, Comtrex, Dimetapp, Robitussin, Tavist-D, and Acutrim -- is effective in relieving nasal congestion. It is also popular in diet pills because it suppresses the appetite.

Two weeks ago, an FDA advisory committee accepted findings in a Yale University study that suggested PPA could be linked to between 200 and 500 hemorrhagic strokes annually.

An FDA analysis indicates that the risk of stroke increases when PPA doses exceed 75 milligrams per day.

Dr. Raymond Woosley of Georgetown University said occasional use of such medications is believed to be safe, but it's when people use them for longer periods that "they have more sustained increases of blood pressure that put them at greater risk (of stroke)."

The Consumer Healthcare Products Association has disputed the study's findings, and said PPA is safe when the drugs are used as directed.

CNN Medical Correspondent Jonathan Aiken contributed to this report.

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U.S. Food and Drug Administration
Consumer Healthcare Products Association
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