Cold Remedies Pulled After FDA Warning
W A S H I N G T O N, Nov. 7, 2000 -- A number of major drug store chains arepulling dozens of over-the-counter cold remedies and diet pillsfrom their shelves after the government warned that an ingredientcould cause hemorrhagic strokes, especially in young women.
The Food and Drug Administration issued an unusually strongwarning Monday, telling Americans to immediately quit using drugscontaining phenylpropanolamine, or PPA, which is found Dexatrim,Tavist-D and dozens of other over-the-counter medicines. Theagency, which intends to ban the ingredient, asked manufacturersvoluntarily to stop selling PPA-containing drugs immediately and toreplace the ingredient with a safer alternative.
Rite Aid, CVS & Walgreen
Rite Aid, with 3,800 drug stores in 30 states and the Districtof Columbia, soon will begin posting warning signs and removingproducts with PPA, spokeswoman Jody Cook said.
“We would advise our customers to check with the pharmacistabout the alternatives,” she said.
CVS Pharmacy, which has 4,100 stores, and Walgreen Co., with3,200 stores, made similar announcements.
Dr. Charles Ganley, the FDA’s nonprescription drugs chief, saidbuyers should be alert for PPA in the ingredient list ofnonprescription cold relievers — both brand names and generic orstore brands — and instead choose decongestant pills with the safealternative pseudoephedrine or use nasal sprays.
Over-the-counter alternatives do not exist for diet pills,however, so dieters will have to consult doctors aboutprescription-only alternatives, Ganley said.
Some Plans Revealed
Whitehall-Robins Healthcare quit shipping PPA-containingDimetapp on Monday. New liquid Dimetapp formulas lacking PPA willhead for store shelves next week, with pill versions to follow.Also, some stores are selling PPA-containing versions of itsRobitussin-CF product, and some are selling a new non-PPA formula,in boxes flagged with a yellow band.
SmithKline Beecham Consumer Healthcare said people should notuse its PPA-containing Contac 12-hour Cold Capsules, but five otherContac versions contain the safe pseudoephedrine.
Even though manufacturers learned three weeks ago that the FDAwas preparing to act, when the agency’s scientific advisersdeclared PPA unsafe, many scrambled Monday to decide what to do.
Top-selling manufacturers that refused to reveal their plansinclude Novartis Corp., maker of PPA-containing Triaminic andTavist-D; Bayer Corp., maker of Alka-Seltzer Plus cold medicines;and Chattem Inc., maker of Dexatrim diet pills.
6 Billion Doses Per Year
About 6 billion doses of PPA are sold in this country each year,mostly without prescriptions. There are a few PPA-containingprescription decongestants, and the FDA asked their makers also tostop selling them while it moves to ban prescription use as well.
While the risk of a hemorrhagic stroke, or bleeding in thebrain, is very small to an individual user, these are often deadlystrokes, and survivors can be left disabled.
With millions of Americans swallowing PPA daily, the FDAestimated it could be to blame for 200 to 500 strokes yearly justin people under age 50.
Hemorrhagic strokes typically occur in the elderly, and areextremely rare under age 50. In the 1980s, however, medicaljournals cited several dozen young women who suddenly had strokesdays after taking their first PPA-containing diet pill.
A five-year Yale University study comparing PPA use among strokesurvivors with healthy people concluded that PPA increases strokerisk for young women within three days of taking PPA-containingappetite suppressants, or within three days of taking theirfirst-ever PPA dose for any reason. In some cases, using PPAincreased stroke risk 12- to 15-fold.
Nobody knows why, although first-time PPA use sometimestemporarily raises blood pressure, an effect that wanes as the bodygets used to the drug. Risk was highest with the higher doses -more than 75 milligrams daily — that dieters typically used.
The study didn’t find men at risk, but the FDA cautioned thatenough men weren’t studied to be sure they’re OK.