By ERIC STEVICK
Herald Writer
The Food and Drug Administration wants drug companies to remove voluntarily over-the-counter cold remedies and diet pills that contain an ingredient that could cause hemorrhagic strokes, and local retail chains are studying the warning.
The government on Monday alerted consumers to the risks posed by products containing phenylpropanolamine, also known as PPA, which is used in nasal decongestants to relieve stuffy nose or sinus congestion and in weight control products to curb appetite.
The FDA warning is based on results of a study conducted by scientists at Yale University that showed an increased risk of hemorrhagic stroke, a bleeding in the brain, in people who were taking PPA.
For consumers, the FDA’s unusually strong health warning says: "We suggest you stop taking the drug immediately and use an alternative."
PPA has been used for many years and "a very small number" of people taking the drug have had strokes, according to an FDA fact sheet.
In the Yale study, PPA increases stroke risk for young women within three days of taking PPA-containing appetite suppressants, or within three days of taking their first-ever PPA dose for any reason. In some cases, using PPA increased stroke risk 12- to 15-fold.
Several chain stores with a presence in Snohomish County said Monday they will wait and see what the FDA ultimately decides to do. The FDA is preparing to ban PPA but legal steps will take a few months.
"I think it’s a heads up to consumers, and we are there to be a resource," said Barry Bartlett, a spokesman for Bartell Drugs, which has 49 stores in the region.
"… The company is going to be monitoring the situation very closely," Bartlett added.
Several retailers were learning secondhand about the FDA warning. In the past, the issue has been debated between the government and manufacturers.
"We currently don’t have any information from the FDA, but when we do we will abide by what they ask us to do and remove whatever they ask to have removed in the manner they ask," said Cherie Myers, a Safeway Co. spokeswoman.
Consumers should look for PPA in the ingredient list of over-the-counter cold medicines and choose decongestant pills containing the safe alternative "pseudoephedrine," said Laura Bradbard, an FDA spokeswoman. Most manufacturers that make the medicines with PPA also have similar products with safe alternatives, she said.
A case in point is Contac. Its 12-hour "Cold Capsules" contain PPA but five other Contac versions contain the safe pseudoephedrrine.
There is no list of which over-the-counter products contain PPA. For now, it will be up to consumers to look for it or for manufacturers to voluntarily stop selling the PPA-containing drugs, Bradbard said.
The risk of a hemorrhagic stroke, or bleeding in the brain, is very small to an individual user. These are often deadly strokes, and survivors can be left disabled. With millions of Americans swallowing PPA daily, the FDA estimated it could be to blame for 200 to 500 strokes just in people younger than age 50.
The FDA’s records show 44 cases of hemorrhagic stroke among PPA users in the past 30 years. Most were women; the median age was 35 — including a few who died while using diet pills even though medical records showed they weren’t overweight.
Nobody knows why PPA increases stroke risk, although first-time PPA use sometimes temporarily raises blood pressure, an effect that wanes as the body gets used to the drug.
The study didn’t find men at risk, but the FDA cautioned that enough men weren’t studied to be sure they’re OK.
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