PPA - Phenylpropanolamine Drug Investigation.
"Protecting Consumer's Health & Pursuing Legal Claims"


Guerry R. Thornton, Jr.

Copyright © - Guerry R. Thornton, Jr. 2001

PPA is an chemical ingredient used in cold relief drugs as a sinus decongestant, and as an appetite suppressant in dietary aids. Based on FDA rules, many widely-used products which contain PPA are sold over-the- counter (OTC). From a scientific standpoint, PPA is similar to amphetamines and has long been known to increase the user's heart rate and stimulate the cardiovascular system.

Phenylpropanolamine has been used for over 50 years and is contained in over 40 products which have been on the market. It has been marketed in various dosage forms, ranging from capsules and tablets to extended- release forms. Commonly used brand names which contain PPA include: Acutrim; Amfed; Dexatrim; Efed; Propagest; Super Odrinex; Thinz-Span; Permathene; and Unitrol Diet Maximum Strength - in the dietary category; and, cold medications, such as Robitussin CF; Dimetapp; Tavist; Triaminic; Contac; Alka-Seltzer.

Based on recent health studies, the FDA warned consumers in November, 2000, to discontinue using dozens of OTC cold remedies and diet pills that contain the PPA ingredient. The FDA issued an unusually strong public health warning because of a recent study by researchers at Yale University, published in the New England Journal of Medicine. The report concluded that women from 18 to 49 years of age who took PPA as an appetite suppressant were as much as 15 times as likely compared to non-users to suffer hemorrhagic strokes, a vascular failure that causes bleeding in the brain. Often, strokes occurred within 3 or 4 days of use. Even first-time users of PPA were 3 times as likely to have hemorrhagic strokes. Health risks may be greater in patients who have high blood pressure, allergies, or other conditions, and may cause other problems, such as mental changes in children or risks to pregnant women.

The health warning by the FDA regarding PPA was accompanied by a voluntary letter to manufacturers of cold decongestants and dietary supplemants asking them to voluntarily withdraw PPA from the market. The non- mandatory measure was taken while the FDA drafted regulations that may permanently ban PPA as an active ingredient from all drugs on the market, hopefully OTC and prescription drugs.

In response to a public health crisis that could cause hundreds, if not, thousands of strokes, most drug companies and pharmacies began the immediate withdrawal of many of the most popular cold remedies and diet suppressants which contain PPA.

Pursuant to regulatory actions and the likelihood of a public health crisis, the legal profession has mobilized to petition the FDA for expedited action and to make certain protections extend to prescription medications. Also, court actions have been initiated to obtain fair compensation for PPA victims who have life disabling, stroke related injuries which can be linked to the use of PPA. A legal network of qualified medical and legal experts has formed to assist PPA victims with viable claims.

PPA personal injury or wrongful death claims include: 1) negligence; 2) strict liability; 3) breach of warranty; 4) misrepresentation; 5) fraud; 6) punitive measures; and, 7) health care malpractice. Because of the prevalent use of PPA in dietary products, legal actions may have similarities to the Fen-Phen mass tort disaster which forced American Home Products Company to establish a settlement plan in national litigation exceeding $4.5 billion in total compensation for Fen- Phen diet users [MDL 1203]. Verdicts and settlments related to Fen-Phen and Redux have exceeded $1.0 million in many cases, with the most recent award being $42 million in Corpus Cristi, Texas.

The pervasive and unregulated use of PPA as an active ingredient in many popular OTC medications may mean that hundreds or thousands of strokes and heart problems have permanently altered the lives of many innocent victims. Fortunately, the FDA has taken direct action and drug liability lawyers have initiated legal claims to compensate victims and protect the safety of the public from the hazards of PPA..



NOTE: Guerry R. Thornton, Jr., is a member of the State Bar of Georgia, counsel to a product liability law firm in Atlanta, GA, and president of NETLAW, an international law consultancy; he has authored articles in Trial Magazine, the Barrister, and the National Law Journal; he has served as counsel for victims in the $2.5 billion Dalkon Shield Claimants Trust, the $3.0 Billion breast implant resolution and the $4.5 billion Diet Drug Litigation Plan.

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