An advisory committee to the US Food and Drug Administration (news - web sites) on Thursday recommended that phenylpropanolamine (PPA)--an ingredient found in many non-prescription cough and cold medications and appetite suppressants--be reclassified as unsafe.

Products that would be affected if the FDA opts to follow the panel's advice include drugs sold under the names Alka-Seltzer Plus, Acutrim, Contac, Comtrex, Dexatrim, Dimetapp, Triaminic and Robittussin CF.

Weight loss medications' arguable status as a ``lifestyle'' drugs and the fact that there are many other weight control aids and cough/cold remedies already available to consumers over-the counter appeared to play a major role in the committee's decision. The recommendation was also based on a study that suggests that PPA may increase an individual's risk of stroke.

``Case reports have linked exposure to PPA to the occurrence of hemorrhagic stroke,'' write Dr. Ralph I. Horwitz from Yale University's School of Medicine, and colleagues in the Hemorrhagic Stoke Project report. Hemorrhagic strokes are characterized by bleeding in the brain.

Horwitz and his colleagues studied over 2000 adults aged 18 to 49, including 702 individuals who were hospitalized due to a stroke. The data was collected over a five-year study period.

Study results show that stroke patients were 50% more likely than the control subjects--those who did not suffer a stroke--to have been exposed to a PPA-containing substance within three days of their stroke event. Those who used PPA-containing cough/cold remedies were about 23% more likely to have a stroke during the study period. However, the risk of stroke increased sixteen-fold for those individuals who used an appetite suppressant that contained PPA.

According to Horwitz, his results are not merely coincidental. In fact, statistical tests prove that such figures ``could not have been expected by chance,'' he said in an interview with Reuters Health.

Yet according to a statement from the Consumer Healthcare Products Association (CHPA), ``the hemorrhagic stroke project did not establish a causal relationship between PPA and hemorrhagic stroke.'' CHPA is a national trade association that represents US manufacturers and distributors of nonprescription, over-the-counter medicines and dietary supplements.

Citing possible errors in classification and memory recall by the subjects, the association maintains that the study results could have been easily skewed. ``For example, a participant could incorrectly recall that they took product A-which contains PPA-when in fact, they took product B-which contains no PPA,'' according to the CHPA.

CHPA asserts the safety and effectiveness of PPA, but allows that it ``may consider, if warranted, recommending additional research to confirm the safety of cough/cold medications and appetite suppressants containing PPA.''

(From Reuters Health)