Cold, diet drugs pulled after warning issued
FDA finds popular medicines have harmful effects
November 26, 2000
If you can’t find your favorite cold or weight-control remedy, it has probably been pulled from the shelf.
Major drug and grocery chains removed dozens of over-the-counter cold medicines and diet pills last month after the Food and Drug Administration (FDA) warned an ingredient could cause hemorrhagic strokes and raise blood pressure.
The agency’s strong warning told Americans to immediately quit using drugs containing phenylpropanolamine, or PPA, which is found in hundreds of medications including Alka-Seltzer, Allerest, Contac, Triaminic, Dimetapp, Robitussin and Dexatrim. The warning came after a five-year Yale University study on PPA to be published Dec. 21 in the New England Journal of Medicine. Because of its potential health implications, the article was released
before its publication date. Health Canada also has issued an advisory warning about PPA.
In Craig, City Market and Safeway have cleaned their shelves of drugs containing PPA.
“Kroger [corporate parent of City Market] put out an order to pull those items weeks ago,” City Market pharmacist Joe Kennedy said this weekend.
PPA is a chemical widely used as a nasal decongestant in cold and cough medications and as an appetite suppressor in diet pills. In the mid-1970s, phenylpropanolamine was classified as a Category I (safe and effective) ingredient by two FDA drug advisory review panels.
According to the FDA, about 6 million doses of PPA are sold in this country each year, mostly without prescriptions. There are a few PPA-containing prescription decongestants, and the FDA has asked their makers also to stop selling them while it moves to ban prescription use as well.
Some drug manufacturers will be replacing PPA in their products with another chemical pseudoephedrine which is approved for safe use by the FDA.
According to Michael Davidson, a research scientist at Florida State University, pseudoephedrine is used as a decongestant in cold remedies; it is a synthetic version of the Chinese herb ephedra, or Ma Huang. Side effects of pseudoephedrine include convulsions, hallucinations, irregular heartbeat, shortness of breath, painful urination, increased blood pressure, headache, trouble sleeping, and unusual nervousness or restlessness. The side effects may increase when pseudoephedrine is used while also taking beta blockers, MAO inhibitors or cocaine. The chemical also may make some existing conditions worse, such as diabetes, enlarged prostrate, glaucoma, heart disease, high blood pressure or an overactive thyroid.
“Speaking as a pharmacist, I sometimes refer people to echinacea or zinc lozenges for colds,” Kennedy said.
Herbs and homeopathic medicines are safe alternatives to drugs containing harmful chemicals, said Mary Funkhouser, herbalist and owner of Naturally Fine Herbs health food store in Craig.
“I don’t recommend echinacea to people anymore because they’ve taken so much of it their systems are becoming immune to it,” Funkhouser said. “Instead, I am now recommending the Chinese herb astragalus. And I emphasize homeopathic because they seem to bring fast and effective results.”
Funkhouser advises people to buy natural remedies, herbs and supplements which are manufactured by reliable companies. “Many manufacturers do not test their products, but just make them and sell them to ‘jobbers’ who then sell them to large chains under generic or store brands. But there are a few reliable companies that analyze their products they have their own laboratories and everything is tested for potency, purity and standardization. Most health food
stores know the good companies, and stand behind the products they sell. If you’re buying cheap herbs, they’re probably not pure or don’t have the standards they need to meet to be effective,” she said.
“Standardization is simply taking the key ingredient that makes the herb work and turning it into a higher potency. Pharmaceutical drugs [prescription drugs] are actually chemicals manufactured from the key ingredient in an herb,” Funkhouser said. “But it’s really important that you have all of what’s in an herb, not just one ingredient, so it can work synergistically with the body.”
The FDA believes that while the PPA-induced risk of a hemorrhagic stroke, or bleeding in the brain, is very small to individual users, the result is often deadly and survivors can be left severely disabled. The agency estimates PPA could be to blame for 200 to 500 strokes yearly just in people under age 50.
Consumers can identify over-the-counter products with PPA by looking for “phenylpropanolamine” in the list of ingredients on the label both in brand names and generic or store labels. They should consult with their health care provider or pharmacist to see if their prescription medication contains PPA.