FDA Issues Warning on Ingredient Found in Many Diet and Cold Medications (dateline November 15, 2000)
|The U.S. Food and Drug Administration
(FDA) has asked pharmaceutical manufacturers to voluntarily stop marketing diet pills or
cold medication products that contain phenylpropanolamine (PPA) because the ingredient has
been linked to an increased risk of stroke. PPA has been available
in many diet pills and cold medications for years. However, a study conducted by Yale
researchers and sponsored by the Consumer Healthcare Products Association (CHPA), an
organization which represents over-the-counter drug manufacturers, found that PPA can
increase the risk of hemorrhagic stroke, primarily in women.
Products that contain PPA include some formulas of:
A stroke is literally a "brain attack," caused when the vital supply of blood and oxygen is cut off to part of the brain. A hemorrhagic stroke is caused by a rupture of a blood vessel that delivers blood to the brain. According to the National Stroke Association, PPA constricts the blood vessels and may seriously raise a persons blood pressure, which may cause a hemorrhage.
"Stroke is a misunderstood, life-threatening medical condition. The FDA is to be applauded for its quick, decisive and live-saving actions," said Patti Shwayder, CEO of the National Stroke Association (NSA), in a NSA statement. "NSA supports any steps to prevent stroke and protect citizens from the devastating effects of this disease," said Shwayder.
In the five-year study on PPA, researchers found a small increase in the risk of stroke, primarily among first-time female PPA users under age 50. The study included 2,000 adults aged 18 to 49, 702 of whom were hospitalized due to a stroke. Researchers found that stroke patients were 50% more likely to have been exposed to a PPA-containing substance within 3 days of their stroke than those who did not suffer a stroke. However, hemorrhagic stroke is very uncommon in young people, even among those who have taken PPA.
According to Charles Ganey, the head of the FDAs division of over-the-counter drugs, the FDA believes that the incidence of stroke from PPA is "very rare;" however, a small risk does exist. Therefore, the FDA has recommended that PPA no longer be ''generally recognized as safe," a standard that is required of all over-the-counter medications.
Lawrence Brass, MD, Professor of Neurology at Yale and a member of the National Stroke Association, said that PPA could be responsible for between 200 and 400 hemorrhagic strokes each year. Among first-time users of diet preparations that contain PPA, there may be a 16-fold increase in the risk of hemorrhagic stroke, according to Dr. Brass.
Within days of the FDAs recommendation to drug manufacturers, many grocery stores, superstores, and Internet pharmacies such as Drugstore.com and PlanetRx.com pulled products containing PPA from their shelves. The FDA recommends that consumers check the backs of cold medications and diet pill packages and make sure that phenylpropanolamine (PPA) is not listed among the ingredients. The FDA also encourages consumers to discuss alternatives to PPA-containing products with their physicians or pharmacists. There are several products on the market that do not contain PPA, including brands such as Sudafed and Benadryl.
According to the National Stroke Association, stroke is the third leading cause of death in the United States. Approximately 750,000 Americans suffer strokes and 160,000 die from strokes each year. It is estimated that that a stroke occurs every 45 seconds in the United States and that someone dies from a stroke every three minutes.