Two big drug makers knew of possible health risks posed by a key ingredient in their over-the-counter medicines, despite company denials consumers could be harmed, according to internal memos.
The ingredient, known as PPA, was used in numerous cold remedies and diet pills including versions of Dimetapp and Tavist-D that were taken by millions of consumers for decades. They were yanked from the market in 2000 at the urging of regulators.
Their withdrawal was prompted by concerns PPA could cause hemorrhagic strokes, especially in young women. Since then, thousands of lawsuits have been filed by consumers against the manufacturers, including Novartis Pharmaceuticals and Wyeth, both of which are based in New Jersey.
The drug makers continue to maintain there was no reliable scientific evidence to link PPA to strokes and that their products were safe. But internal company documents introduced last month as evidence in the lawsuits indicate the companies were aware of the health risks for years.
For example, in a Jan. 19, 1989, memo, Margaret Flory, an executive at Sandoz Pharmaceuticals, which is now part of Novartis, wrote a Sandoz official that PPA produced “dire outcomes in small doses; it isn’t only abuse or overdoses which cause problems.”
A three-page memo in 1996 from Allen Perelson of Wyeth-Ayerst Pharmaceuticals, a unit of Wyeth, to a Wyeth colleague in Thailand, acknowledged strokes and other side effects were reported in patients following excessive and recommended doses of products with PPA. However, he also maintained Dimetapp, which was made by Wyeth-Ayerst was safe when taken according to direction.
Spokespeople for the company denied the products were unsafe.
More than 300 individual lawsuits have been filed over the past three years in State Superior Court in New Brunswick. The lawsuits are not a class action, although a federal court in Seattle is presiding over a class action against drug makers involving similar claims.
The companies’ “own internal memos reveal that they knew for many years that their PPA products were capable of causing hemorrhagic strokes and other injuries,” wrote the attorneys who filed the lawsuits on behalf of New Jersey consumers.
Fran Sullivan, a spokesman for Wyeth, which is based in Madison, said he couldn’t comment, because the dispute is the subject of litigation.
A spokeswoman for Novartis, which is based in East Hanover, said “We steadfastly stand by our decisions relating to this product. We do believe that a thorough review of the complete memo would show that statement to have been taken out of context.”
Nancy Fitzsimmons, the Novartis spokeswoman, said the 1989 memo that described health risks associated with PPA referred only to cases in which serious side effects were reported. The company maintained that did not establish scientific links between PPA and strokes.
The memo, which said PPA was “reasonably safe,” listed side-effect cases and also compared PPA with a different substance, pseudoephredine, which has a similar chemical structure. The memo went on to suggest pseudoephredine may be a “realistic alternative” to PPA as an ingredient.
The controversy over PPA, which is known in the pharmaceutical industry as phenylpropanolamine, has raged for years.
The ingredient, which was created in the early 1900’s, was marketed for decades in various over-the-counter medicines as a way to suppress appetites or relieve runny noses.
Those products included many popular products, such as Alka-Seltzer Plus, Contac 12-hour cold capsules and Dexatrim diet pills, which like other over-the-counter medicines, don’t require a prescription.
Until the recall in 2000 by the drug makers, which also included Bayer Corp. and GlaxoSmithkline plc, about 6 billion doses of PPA were reportedly sold each year in the U.S., mostly in over-the-counter products.
But reports of strokes prompted Congressional hearings in 1991. And by 1996, the Food and Drug Administration proposed additional warnings on the labeling for all products containing PPA. The agency also pursued a comprehensive safety study.
That study, which was conducted by researchers at Yale University and funded by the drug makers, was completed by the fall of 2000. The results indicated PPA may increase the risk of stroke, so the FDA issued a public health advisory and the products were withdrawn.
Even then, the drug makers acted reluctantly.
A September 2000 memo written to the FDA by an industry trade group known as the Consumer Healthcare Products Association insisted PPA “remains safe and effective as an OTC appetite suppressant and nasal decongestant when used according to directions.”