Smoking Gun Documents: Phenylpropanolamine (PPA) Dangers
Senator Urges FDA to Keep Harmful Drug on the Market
- September 1984: The FDA was ready in 1984 to strip PPA of its classification as safe and effective until a letter from Senator Alfonse D'Amato arrived on behalf of the manufacturers of OTC drugs containing PPA. Ultimately PPA was proven to trigger stroke as suspected beginning in the late 1970s but the senator's lobbying succeeded in keeping the drug on the market in a number of over-the-counter products until November 2000.
Drug's Manufacturer Discourages Safety Measures Because of Cost
- October 1988: Sandoz Pharmaceutical executives note "a significant increase in material costs" if pseudoephedrine (PSE) is substituted for phenylpropanolamine (PPA). Unlike PPA, PSE was categorized as safe, but the memo advises "few consumers" know the ingredients of cold remedies and "fewer still are aware of any safety issues with PPA."
Suspicion About Safety of PPA Grows...
- October 1989: Sandoz internal memo recognizing that PPA "was coming under closer scrutiny because of the recognition of serious cardiovascular and CNS [central nervous system] adverse events attributable to therapeutic doses."
- September 1990: Dr. Thaddeus E. Prout, an associate professor at Johns Hopkins University School of Medicine, testified to the House Committee on Small Business that dangerous PPA side effects had been known for at least 20 years but were "grossly under-reported." Prout testified that safe substitutes were available and removing PPA from the market "would not leave a deficit of any kind." Dr. Prout also testified: "I defy anyone to identify another unregulated drug that has such a record for disaster."
...Yet Manufacturer Continues to Put Profits First
- November 1990: A Sandoz executive recommends against substituting PSE for PPA. "If we were to convert all formulas to PSE, it would have a negative effect on profit to the tune of $3.3 million."
FDA Aware of PPA's Dangerous Side Effects
- December 1990: FDA staff prepares for in-coming FDA Commissioner Dr. David Kessler a chronology of regulatory actions regarding PPA that shows concerns about the drug stretched back to 1973.
- April 1991: In a memo titled "Epidemiologic review of phenylpropanolamine safety issues," an FDA medical officer estimates 10 million people take diet drugs containing PPA. In the 12 years 1969 to 1991 the FDA had received 29 spontaneous reports of hemorrhagic stroke. The memo notes that only about 5 percent of "adverse drug events" for prescription drugs are reported and the percentage is even smaller for OTC drugs. Dr. Jolson, concluded that a "number of lines of evidence suggest that PPA-containing diet products increase the risk of CVA [cerebrovascular accident]."
Common Cold Medicine Contains PPA
- June 1992: Sandoz presses FDA to complete review of TAVIST, which contained PPA, as effective for treatment of colds. Sandoz is eager to enter TAVIST in the $1.7 billion seasonal market for cold remedies.
Novartis CEO Was Warned That PPA Was Less Safe than Alternative
- January 1993: A Novartis scientist submits an analysis of the relative safety of PPA and PSE (pseudoephedrine) to CEO Robert Donovan that concludes "Compared to PPA, PSE is probably less likely to cause severe adverse effects."
Information Left Off Warning Labels
- January 1996: Sandoz marketing executives decide against warning labeling changes for Tavist D, Tavist 1 and Triaminic 12, three popular OTC medicines containing PPA.
Industry Study Demonstrates Clear Stroke Link
- May 2000: Researchers at Yale complete an industry-funded study that finds men and women 18-49 who took a PPA diet drug were 15 times more likely to have a stroke after one dose than if they had not taken the drug. They were three times more likely to have a stroke after one dose of a PPA cold or allergy remedy.
After 20 Years, FDA Finally Steps In
- November 2000: FDA "requests" drug makers cease the use of PPA. Within days and with no noticeable market disruption PPA cold, allergy and diet drugs vanish and are replaced, mostly with PPE formulations.