To: Sir Auric Goldfinger who wrote (2699 ) 10/21/2000 6:00:41 PM From: Sir Auric Goldfinger Respond to of 5582 So what are GUMM & Hertitage doing about phenylpropanolamine (PPA)?: "FDA Panel Says OTC Drug Linked to Strokes By Lisa Richwine GAITHERSBURG, Md. (Reuters) - An ingredient in dozens of cold remedies and weight-loss drugs is linked to a higher risk of strokes, an advisory panel said on Thursday in a move that could lead to a ban on the chemical in over-the-counter drug products. The ingredient, phenylpropanolamine (PPA), appears in products used by millions of Americans, including Dexatrim and Acutrim for weight loss and cough and cold medicines such as Dimetapp. The panel, a group of experts that advises the Food and Drug Administration (FDA), said the low risk of strokes in people age 18 to 49 appeared elevated, although still small, among people who took products containing PPA. "We've heard data suggesting fairly strongly there is an association," said panel member Dr. Edwin Gilliam, adding the risk appeared highest among women and first-time users of PPA products. That conclusion, which an industry group challenged, led the panel to vote that the ingredient could not be "generally recognized as safe," an FDA standard for nonprescription products. The FDA usually follows its panels' advice but would need to take several regulatory steps before it could order a recall of PPA-containing products. PPA is the only approved, active ingredient for over-the-counter diet drugs. Other chemicals are available for cough and cold remedies. The FDA estimated that pulling PPA products from the market could prevent between 200 and 500 hemorrhagic strokes, a type of bleeding on the brain, each year among people age 18 to 49. U.S. consumers bought about 6 billion doses of PPA last year. The FDA analysis was based on a study by the Yale School of Medicine that was funded by the Consumer Healthcare Products Association, a trade group that represents makers of over-the-counter drugs. The industry group, however, vigorously attacked the findings, saying the number of patients in the study who took PPA-containing products was small and that many had other stroke risk factors, such as being a smoker. The organization, as well as a group of experts it hired, said the study results were inconclusive. "We're not sure there is an increased risk (of stroke), but if there is, it appears to be exceedingly small," said Dr. Noel Weiss, a University of Washington epidemiologist and one of the industry consultants. The FDA has been concerned about PPA since 1982 when it first received reports that the ingredient might raise blood pressure. To address safety concerns, the industry proposed the Yale study in 1992. The Dexatrim family of products is made by Chattanooga, Tenn.-based Chattem Inc. (CHTT.O), while the Acutrim group of products is made by Brookfield, Conn.-based Heritage Consumer Products LLC. Carole McLemore, a spokeswoman for Heritage, said the company was "not considering" pulling Acutrim from the market. "We believe the product is safe or otherwise we wouldn't have it on the market," McLemore said."