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April 15, 2003 - Companies may have known about PPA stroke link

Internal memos show that two large drug makers knew about the link between PPA and strokes. In 2000, PPA was taken off the market because of the serious and concerning PPA side effects linked to the popular ingredient. Used in many cold remedies and diet pills, PPA was linked to hemorrhagic strokes that affected mainly young women, causing a high number of PPA lawsuits.

The companies named in the 300 individual PPA lawsuits were New Jersey companies Novartis Pharmaceuticals and Wyeth and the companies have maintained there was a lack of concrete scientific evidence leading them to ascertain the strokes were the result of PPA. Now it appears that the companies may have been sitting on PPA side effects evidence. Just last month, evidence began to surface that showed the companies may have known PPA side effect risks for years despite adamant denials.

First made in the early 1900s, PPA had been available in a wide range of over-the-counter medications for decades. Six billion doses of PPA were sold in the U.S. alone every year. Not until 1991 when reports of strokes led to Congressional hearings was the widely used ingredient ever addressed. In 1996, the FDA proposed that additional PPA warning labeling be added to all PPA containing products. A Yale University PPA study was finally completed in 2000 showing evidence that there was an increased risk of stroke with PPA use that led to the FDA withdrawal.

Memos used in recent PPA lawsuits have shown that as early as 1989 executives may have known about possible PPA side effects. A January 19, 1989 Sandoz Pharmaceutical (now Novartis) memo was written acknowledging that PPA side effects occurred in small doses, not just in instances of abuse or overdose. In 1996, a three-page Wyeth-Ayerst Pharmaceutical memo made note that strokes and other side effects were reported in patients following excessive and recommended doses of products with PPA.

February 8, 2001
A report from the General Accounting Office has found eight of ten prescription drugs that were withdrawn from the U.S. market since January 1, 1997 may have posed a greater health risk to women than to men. Although in about half the cases risk were greater to women because more women were using the prescription drugs containing PPA, there were certain drugs that when prescribed more evenly to men and women physiological differences between the sexes may account for a higher incremental risk to the women than the men. The particular PPA containing drugs that demonstrated a higher risk of side effects to women included withdrawn hypertension drug Poscior, antihistamines Seldane and Hismanal, and heartburn drug Propulsid. At the end of last year, the FDA started taking steps to remove PPA from over the counter medicines found in cold remedies and weight loss products because of the evidence showing PPA increased the risk of hemorrhagic stroke in women but not men.

August 22, 2001
A study in the Journal of the American Medical Association showed weight loss products containing PPA, including Dexatrim and Acutrim that has come under FDA scrutiny, can interact with other medications. The FDA has requested all drug companies that have products containing PPA discontinue marketing because PPA is shown to increase the risk of hemorrhagic stroke, which is bleeding into the brain or into tissue surrounding the brain.

November 28, 2000
PPA, which is found in dozens of over the counter cold remedies and diet drugs, will be banned soon. Depending on when and how much drug companies knew, PPA lawsuits may be soon to follow.

November 11, 2000
The FDA issued a warning for Americans not to use over the counter cold remedies and diet pills that contain PPA because it causes hemorrhagic strokes, especially in young women. Cold remedies containing PPA includes Alka-Seltzer Plus, Comtrex, Contac 12, Coricidin D, Dimetapp, Robitussin, Tavist-D, Traiminic, and appetite suppressants containing PPA include Acutrim and Dexatrim. These PPA containing medicines are brand names so it is important to check if the generic and/or store brands also contain PPA. Currently, the only appetite suppressants that are non-prescription contain PPA so other alternatives should be sought.


November 8, 2000
The FDA asked drug companies to stop marketing popular cold remedies and appetite suppressants that contain PPA due to the link to hemorrhagic stroke in women. The FDA says they are taking steps to remove PPA from the over the counter and prescription medications. This announcement came on November 6th after the New England Journal of Medicine released a 5-year study linking PPA to hemorrhagic stroke in women.

The FDA's advisory committee cited this study when saying that PPA is unsafe. Researchers at the Yale University School of Medicine, who performed the study, found that women ages 18-49 who took appetite suppressants containing PPA were 16 times more likely to have a hemorrhagic stroke than other women and women using cold or cough remedies containing PPA for the first time had a threefold increased risk of hemorrhagic stroke.


November 7, 2000
Drugs stores are now pulling dozens of over the counter cold remedies and diet pills off the shelves following the government warning that PPA can cause hemorrhagic strokes, especially amongst young women. The FDA is getting ready to ban PPA that will take several months to go through the legal steps. Manufactures were asked by the FDA to voluntarily stop selling their products that contain PPA and replace the ingredient with a safer alternative. The FDA had an unusually strong health warning to consumers saying "We suggest you stop taking the drug immediately and use an alternative."

Consumers were warned to check their prescriptions to make sure they aren't taking medications with PPA. Some top selling manufacturers refused to reveal their plans regarding their PPA containing products, including maker of Triaminic and Tavist-D, Alka-Seltzer Plus, and Dexatrim. About 6 billion doses of PPA are sold in the U.S. every year, with the majority of drugs not requiring a prescription. While the study found women more at risk for hemorrhagic strokes when using a PPA containing product, the FDA cautioned that not enough men were studied to ensure they are safe.

October 20, 2000
One day after a U.S. regulatory panel recommended banning PPA some drug companies announced they are in the process of replacing the PPA found in many diet aids and decongestants. The drug companies are under pressure to act quickly or be accused of knowing the dangers of PPA that would result in PPA lawsuits. In anticipation of a PPA recall, many drug companies have begun to market new versions of their over the counter products without PPA. As with every drug and legal action, it will depend on when and how much drug companies knew to see if PPA lawsuits are soon to follow. Other drug manufacturers are still disputing the Yale study, arguing there is no proof that PPA causes hemorrhagic strokes.


Public Citizen Links

Public Citizen is the consumer advocacy group that first expressed their concern over the safety of PPA as early as 1983. The group has been very proactive in their desire to remove PPA containing products from the market and have gone straight to the FDA to do so. PPA was recalled in November 2000 following a study linking PPA to hemorrhagic stroke. If you would like to speak with a PPA attorney regarding the PPA Lawsuit, contact us.

October 12, 2001
Letter urging the FDA to reject drug industry's request for liability disclaimer in its withdrawal of products containing PPA.
The FDA had issued a notice of a "Proposal to Withdraw Approval of New Drug Applications and Abbreviated New Drug Applications" on August 14, 2001 for products containing PPA because of the safety concerns showing the link between PPA and hemorrhagic strokes. Letters from some drug companies to the FDA requested the FDA include in its final rule withdrawing approval of products containing PPA a disclaimer regarding industry liability and PPA lawsuits. The disclaimer would state the withdrawal of PPA containing drugs does not mean the drugs were marketed negligently, which is the companies' request in hopes of avoiding product liability PPA lawsuits.

To read the entire letter click here.

October 19, 2000
Petition to the Food and Drug Administration requesting an immediate ban of all uses of PPA in over the counter products.
Public Citizen petitioned the FDA for an immediate ban of all uses of PPA in over the counter products. PPA was found in many weight loss drugs and cold remedies. The consumer group found that there was an abundant amount of evidence showing the dangers of PPA, in addition to the 5-year Yale study finding "PPA increases the risk for hemorrhagic stroke." There have been reports dating as far back as 1979 showing the adverse effects that can occur when using a product containing PPA, including hemorrhagic strokes.

Ten years ago a review of PPA found 142 cases of adverse reactions that included 24 intracranial hemorrhages, eight seizures, and eight deaths. Most of the adverse reactions were due to hemorrhagic strokes. There are also FDA reports showing that there was evidence of PPA causing hemorrhagic strokes. An FDA memo dated August 6, 1991 shows an FDA medical officer reported that there had been a total of 44 cases of strokes with 35 of them being hemorrhagic strokes. There was an updated added to the report on a September 27, 2000 memo stating an additional 16 cases of hemorrhagic strokes were associated to PPA.

To read the entire petition click here.


October 19, 2000
Testimony before the Food and Drug Administration NonPrescription Drugs Advisory Committee Meeting on Safety Issues of PPA.
Public Citizen made a testimony before the FDA regarding their petition asking for an immediate ban of all uses of PPA in over the counter products found in cold remedies and appetite suppressants. The group cited the Yale study finding "PPA increases the risk for hemorrhagic stroke".

To read the entire publication testimony click here.