For decades, drug manufacturers added PPA, a manufactured sympathomimetic amine, into Accutrim, Dexatrim, Robitussin, Comtrex, Triaminic, and Tavist-D. At one moment, the public ingested 6 million doses of these medications per year through syrups, tablets, solutions, and capsules.
Yet, ingredient labels didn’t list it as PPA. Instead, the substance came from Allerx-D, Dallegy, Extendryl JR, Extendryl SR, Phenylephrine CM, Rescon ER, and Stahist.
By the 1970s, news of PPA-associated strokes started to materialize, and to pursue this, a 1984 study investigated the correlation, but its results were inconclusive. Over a decade later, the Consumer Health Products Association and the FDA chose to sponsor an independent study exploring this relationship. After four years of examination, results were publicized in the New England Journal of Medicine in 2000 – this time with a precise relationship shown between raised stroke risks and PPA usage. Particularly, women’s risk increased 16 times and men’s three times.
After the results, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) advised PPA be removed from OTC nasal decongestants and weight loss aids. Two years later, lawsuits started at the state level.
Many over-the-counter cough medicines contain Phenylpropanolamine, otherwise known as PPA. A Yale Medical School study discovered an increased risk of hemorrhagic stroke (bleeding within the brain) due to using by-products containing PPA. Based on these findings, the Food and Drug Administration (FDA) in November 2000 asked drug manufacturers to stop creating medicines containing PPA.
What Are the Side Effects of PPA?
PPA, however, hasn’t been eradicated from the market completely and is still seen in prescription medications like Rinexin in the U.S. The substance has been found as a component of methamphetamine – and is incredibly harmful when misused.
While its more extreme side effects include hemorrhagic strokes and bleeding onto the brain, PPA has been associated with a spectrum of symptoms:
- Nausea
- Laborious urination
- Restlessness
- Jitters
- Flushing of the skin and sweating
- Panic attacks
- Arrhythmia and fast heartbeat
- Pulmonary edema
- Blood pressure spikes
- Primary pulmonary hypertension
PPA has narrowed the lung’s blood vessels and increased pulmonary arterial pressure for the latter of these conditions.
What Specific Over the Counter Products Contain Phenylpropanolamine (PPA)?
Manufacturers of some of the world’s most reputable cold and cough medications have been reeling from the Food and Drug Administration’s fallout finding that the primary ingredient in many widespread over-the-counter drugs, Phenylpropanolamine or “PPA,” may be unreasonably treacherous. PPA is used in such prevalent cold medicines as Contac 12, Alka Seltzer Plus, Tavist-D, Triaminic, Dimetapp, Robitussin, and Triaminic. PPA is also seen in weight loss products such as Dexatrim and Acutrim.
The FDA’s investigations have shown an increased chance of stroke associated with PPA. While the PPA recall is currently voluntary, the FDA is formulating an official and mandatory policy to ban PPA. PPA has been associated with strokes in women under 50. Most of the strokes started with a painful headache, stiff neck, and some loss of consciousness. The headaches are often predecessors to stroke and can transpire several days before the full onset of stroke. Although infrequent, the strokes caused by PPA are likely to be severe and deadly.
Many young women who experienced a stroke did so after only one dose of Phenylpropanolamine or PPA. The FDA calculates that yearly between 200 and 500 strokes are associated with using products that include PPA. Generally, the stroke happens within three days of ingesting PPA. The most likely type of stroke associated with PPA is the hemorrhagic stroke, which involves bleeding in the brain.
Although most of these products have been taken off the market, the ones that contain phenylpropanolamine include Tavist-D, Dimetapp, Robitussin, Vicks, and Alka Seltzer Plus. Any cold and cough medicines purchased over the counter should be inspected for phenylpropanolamine, or a pharmacist may be consulted. Some over-the-counter diet prescriptions such as Dexatrim and Accutrim may also contain phenylpropanolamine.
Who Is Most at Risk from Using Phenylpropanolamine (PPA)?
Women have a much higher risk of stroke due to using products containing Phenylpropanolamine, although men are also at risk.
PPA has become newsworthy because of the study by Yale University that established the relationship between this over-the-counter drug and stroke due to an elevated blood pressure inside the brain that causes the blood vessels there to burst, also called a hemorrhagic (bleeding) or hypertensive stroke.
Hemorrhagic strokes typically happen in the elderly and are exceedingly rare in those under 50. This five-year Yale University study comparing PPA use among stroke survivors with healthy people concluded that PPA raises stroke risk for young women within three days of taking appetite suppressants containing PPA or within three days of taking their first-ever PPA.
PPA was used as an ingredient in many over-the-counter medications and prescription medications for colds, sinus, allergy, cough drugs, and diet and appetite suppressant drugs and was found in over 400 products, which included over-the-counter appetite suppressants and cough and cold remedies. A few of the more everyday over-the-counter medications that contained PPA are Acutrim, Alka Seltzer, Alka Seltzer Cold Plus Medicine, Contact, Dimetapp, Dristan, Halls Menthol-Lyptus, Robitussin, Sine-Off, Tavist-D, and Triaminic.
After taking PPA, a 29-year-old woman with no prior medical problems suffered a hypertensive stroke. This was written up on the front page of The New York Times on December 13, 2000. Some current litigation involves Alka Seltzer Plus, which once contained PPA and was marketed as a cold treatment or for nasal congestion. Some consumers taking a prescription medicine containing PPA developed a hypertensive crisis and stroke soon after using the drug. In one case concerning a famous New York photographer, death transpired within hours of PPA use.
Another case involved Tavist-D, made by Novartis (formerly Sandoz), taken as a cold remedy.
Another case involved PPA in a product marketed for weight reduction because of its innate appetite suppression effect.
The Yale study showed a substantial risk of hemorrhagic stroke in users of PPA, with or without simultaneous use of other drugs. On the muscle of that study and multiple side effect reports, an FDA advisory panel cautioned in October 2000 that PPA in over-the-counter drugs was dangerous and should be withdrawn from non-prescription drugs. Other more unassailable drugs were available for the same purposes PPA was used. Close on the heels of that advisory warning, it was announced that the FDA has moved to prohibit over-the-counter sales of PPA because of the raised risk of hemorrhagic stroke for users. The manufacturers of PPA have pulled their products from store shelves in the wake of the FDA’s actions.
Consumers should not use any products that have PPA (phenylpropanolamine) because PPA is thought to be responsible for 200 to 500 bleeding strokes each year. While these products were reformulated and PPA was removed, they were never recalled. These products may be lurking in your medication cupboard.
A Family Member or I Suffered a Stroke While Taking a Medicine Containing Phenylpropanolamine. Do I Have a Claim?
Anyone who thinks they were injured using Phenylpropanolamine (PPA) should consult a lawyer. Time is of the essence since many claims need to be filed within a limited time period. A class action attorney is also useful because pharmaceutical companies are often very fierce in defending these claims.
The pharmaceutical company may argue that your lifestyle or imperfect habits caused the injury rather than their products. Exemplary legal counsel will represent your interests and help you or an injured family member obtain proper compensation.
