WASHINGTON — The Food and Drug Administration, in an unusually strong warning, on Monday told consumers to stop using dozens of over-the-counter cough and cold remedies and weight-loss products because of an ingredient that could cause strokes, especially in young women.
Phenylpropanolamine, or PPA, is found in nonprescription medications ranging from Contac and Triaminic to Acutrim and Dexatrim. The ingredient is believed to carry a risk of causing hemorrhagic strokes, or bleeding into the brain.
The FDA is taking steps to ban the substance completely. But since that process will take months to complete, the agency asked drug manufacturers Monday to voluntarily stop selling products that contain PPA and to provide safer alternatives.
The response from the drug industry was swift.
SmithKline Beecham Consumer Healthcare ordered retailers to remove Contac 12-hour Cold Capsules from their shelves. The manufacturer said there are five other versions of Contac that include an alternative substance, pseudoephedrine, that has been proved safe. Still, SmithKline Beecham urged consumers to call its hotline, (800) 245-1040, with any questions.
Dimetapp Shipments Are Reportedly Halted
Whitehall-Robins Healthcare also reportedly stopped shipping its PPA-containing cold remedy Dimetapp on Monday. New liquid formulas of Dimetapp that don't contain PPA will be shipped to retailers next week, with pill versions to follow later. Consumers also were advised that non-PPA versions of the cough formula Robitussin can be found in boxes marked with a yellow band.
And Walgreens began pulling all PPA-containing products from its 3,200 drugstores in 43 states.
In its warning, the FDA said: "We suggest you stop taking the drug immediately and use an alternative." Consumers were advised to check the labels or packaging of their medications to see whether they contain PPA and to discuss alternative over-the-counter and prescription products with their health care providers or pharmacists.
Dr. Charles Ganley, who heads the FDA's nonprescription drugs office, said PPA is contained in every over-the-counter diet drug. But there are several prescription drugs that do not contain the chemical, he said, so consumers should consult their physicians.
FDA Officials Cite Increased Risk
FDA officials said that "the increased risk of hemorrhagic stroke was detected among women using [PPA-containing drugs] for weight control and for nasal congestion in the three days after starting use of the medication." It said some men also may be at risk.
The agency estimated that 6 billion doses of PPA are sold in this country each year, the vast majority without a prescription.
The warning followed a recently completed study by scientists at Yale University School of Medicine, whose results were reviewed last month by the agency's nonprescription drugs advisory committee.
"Although the risk of hemorrhagic stroke is very low, even with PPA use," the agency said, it seemed imprudent for consumers to take such a chance for the sake of controlling colds or suppressing appetites.
A discussion of PPA published Monday in the New England Journal of Medicine said that affected patients in the Yale study were most commonly adolescent girls or women between the ages of 17 and 45 who were using PPA-containing appetite suppressants, often for the first time.
(The study did not find that men also are vulnerable to the stroke risk. The FDA cautioned, however, that the study did not include enough men to determine that they are immune to PPA-related danger.)
The journal said that between 1969 and 1991, the FDA received 22 reports of hemorrhagic stroke associated with PPA. Sixteen of those cases involved appetite suppressants, and six cases involved cough or cold remedies.
The first public warning signs about PPA arose in the 1980s, when medical journals cited several dozen puzzling cases of young women who experienced strokes within days of taking appetite suppressants.
The reasons why PPA seems to cause strokes in some people and not others is unclear. First-time PPA use, however, sometimes temporarily raises blood pressure, an effect that wanes as the body grows accustomed to the drug, some physicians believe. In the Yale study of 702 stroke survivors, the risks were highest with the higher doses--more than 75 milligrams daily--that dieters typically used.
Some scientists for drug manufacturers have argued that concern over PPA is overblown, since it has been used in products for 50 years. But last month, the FDA's scientific advisors dealt the firms a blow when they held a public hearing and voted unanimously that PPA is unsafe.
"It did not meet the burden of proof for safety," said Dr. Eric Brass, chairman of the panel of independent experts and head of the department of medicine at Harbor-UCLA Medical Center.
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