GAITHERSBURG, Md. -- Retailers were generally mum about conclusions concerning phenylpropanolamine (PPA), an active ingredient in 35 over-the-counter diet and cough and cold medications, that it could possibly contribute to strokes, according to a recent study.
Several retailers SN surveyed declined to comment on the Food and Drug Administration's findings that the chemical may lead to hemorrhagic strokes in consumers ages 18 to 49. A panel of epidemiologists, pediatricians, doctors of internal medicine, hospital directors and a consumer representative convened here at an Oct. 19 non-prescription drug advisory meeting to discuss results of the five-year study, according to the Rockville, Md.-based FDA's public affairs specialist, Laura Bradbard.
"The panels voted on questions and concerns about PPA, and no one voted that it was safe," she said. Bradbard said the chemical raises blood pressure shortly after taking products that contain PPA, such as Dimetapp, Alka-Seltzer Plus or Acutrim. "It's the fast rise and fall of blood pressure that can possibly lead to stroke," she said.
Several retailers declined comment on the subject, although Bob Patton, a general merchandise and health and beauty manager at Harold Friedman Co. in Butler, Pa., said, "I'm not familiar with the findings, but I think people won't pick up [the products] if there are side effects like that." Patton said that the array of OTC medications would probably suffer slightly from the negative press, but "I don't know how many people would take it to heart -- I know I wouldn't take it [the medication]."
Depending upon what action the FDA takes on the study, from a health perspective it may end up being positive, said John Beckner, director of pharmacy and whole health, Ukrop's Super Markets, Richmond, Va. "This may just heighten awareness" and get more people to read labels, he said. "They'll either read the ingredients themselves or seek the pharmacist's help in deciphering the information."
The Yale School of Medicine conducted the study starting in 1995, while the Consumer Healthcare Products Association, a Washington, D.C.-based trade group representing OTC drug manufacturers, funded it. Donna Edenhart, the CHPA's deputy director of public affairs, said the study was prompted after the FDA thought further research was needed. She said it did not show a direct cause-and-effect relationship between hemorrhagic stroke and PPA.
She said, "PPA is safe when taken as directed." She added that the organization funded the study because "we do things in the best interest of the consumer."
Although the CHPA is not displeased with the study, Edenhart said the results were flawed, and recent reports suggesting there will be a definite ban on medication containing PPA are incorrect. "We're still waiting to hear from the FDA on what will happen next."
Bradbard stood firm on PPA's dangers though. "We feel the Yale study was a good one, and it agreed with our raw data." She said the strokes strike soon after taking one of the products, and the dangers are in proportion to the length of time consumers have taken the medications.
"You don't know if someone has a weak blood vessel in their brain," she said. "There are alternatives -- it's possible to make products that will remedy the same symptoms without using PPA."
Reservations about the chemical reaches back to 1982, when physicians reported sporadic but serious adverse effects to the FDA, according to Bradbard. U.S. consumers purchased approximately 6 billion doses of PPA last year, according to a press release.