Toxic Topics - PPA


1. What is PPA?

Phenylpropanolamine ("fen-el-pro-pa-nol-a-mine" or "PPA") is an ingredient used in many over-the-counter and prescription cough and cold medications as a decongestant to relieve stuffy nose or sinus congestion and in over-the-counter weight loss products.

PPA has been available for at least 53 years, if not longer. Americans take 6 billion doses of the ingredient each year in a wide range of prescription and over-the-counter products, including the popular brand names Alka-Seltzer Cold, Bayer Cold, Dexatrim, Dimetapp, Robitussin-CF, Dristan, Tavis-D, Allerest, Triaminic, Allergy Relief, Contac, and Sucrets Cold. By some calculations there are as many as 400 over-the-counter products containing PPA.

2. Adverse Events

A recent industry funded study conducted by Yale University found that PPA increases the risk for hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain). The study included a long history of published serious adverse events, including hemorrhagic stroke, attributed to PPA going back to 1979. These cases were attributable to PPA because they typically occurred close in time to ingestion of PPA in otherwise healthy younger people. There was a lack of other plausible explanation for the occurrence of these events in these younger individuals. In addition, PPA is known to cause cerebral vasculitis, a severe inflammation of the blood vessels in the brain, which in combination with the blood pressure raising effects of PPA, can result in cerebral or subarachnoid brain hemorrhage and stroke. Since the dangers of PPA were not previously known to the public, it is highly likely that many such individuals who suffered hemorrhagic stroke never associated this terrible event with their use of products containing this drug. Further, even doctors and other medical personnel may well have failed to make the connection between the stroke and PPA, because they were unfamiliar with the dangers of the drug.

Symptoms include headache, nausea and stimulation. Other than stroke, acute psychosis, convulsions, acute renal failure, heart damage and hypertension have also been reported.

Though the Food and Drug Administration (FDA) has only 51 confirmed reports of hemorrhagic stroke, analysts relying upon the Yale Study now estimate that 200-500 strokes occurred per year in women age 18-49 due to PPA. It is well known that only a very small percentage of adverse drug reactions are ever reported to the FDA. With estimates that the percent of cases of over-the-counter adverse drug reactions that are sent to the FDA are between 5% and 10% of those that actually occur, this total of 51 reported cases of hemorrhagic stroke can mean as many as 510 to 1020 cases have actually occurred in persons using PPA containing products.

3. Regulatory Action

On October 19, 2000 Public Citizen formally petitioned the FDA for an immediate ban on the use of PPA in all over the counter products, and on the same day the FDA convened a meeting of its Nonprescription Drugs Advisory Committee to discuss the safety issues of PPA in over-the-counter drug products. The Committee determined that there is an association between PPA and hemorrhagic stroke. A letter was sent to the manufacturers of drug products containing PPA by the FDA on November 3, 2000. This letter asked manufacturers to voluntarily discontinue marketing products with PPA in the interests of public health. Manufacturers were further requested to reformulate such products with other ingredients.

On November 6, 2000, in response to the Yale study, the FDA ordered that all over-the-counter manufacturers remove PPA from their products. The FDA determined that the conditions for which PPA is used did not justify the risk of serious harm posed by the drug. The FDA concluded that PPA "cannot be considered to be safe for continued use". (FDA Talk Paper, 11/6/00) .

4. Population at Risk

The Yale study of patients at 43 hospitals found that women aged 18 to 49 who had taken appetite suppressants with PPA were 16 times more likely to suffer a hemorrhagic stroke. There was no reason to believe that men face a lower risk. Further, among men and women taking a cough or cold remedy containing PPA for the first time, the risk of a stroke was three times higher than normal.

5. Precautions

There are other available products on the market not containing PPA that can fulfill the same role as the withdrawn products. Consumers should ask their pharmacist or health care provider what other products are available for their needs. Over-the-counter drug products containing this ingredient may be identified by looking for "phenylpropanolamine" in the list of active ingredients on the label. If a prescription nasal decongestant or cough/cold product is being used, consumers should talk to their pharmacist or health care provider to determine if PPA is present.

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