On November 3, 2000, the FDA issued a letter to drug manufacturers that sold products containing PPA asking them to voluntarily discontinue marketing their products as a result of the studies demonstrating the incidence of hemorrhagic strokes to occur mostly in young women. To view the letter
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A hemorrhagic stroke is the least common type of stroke that is often deadly and can leave survivors disabled. Only about 20% of strokes are hemorrhagic that occurs when a clot obstructs a blood vessel to the brain and the blood vessel in or around the brain ruptures, but the results can be devastating. Hemorrhagic strokes can strike at any time and can occur in younger people as well.

PPA Lawsuit News Links

November 28, 2000
PPA, which is found in dozens of over the counter cold remedies and diet drugs, will be banned soon

. . read more . .

PPA Lawsuit

FDA ANNOUNCES PPA RECALL!

PPA is an active ingredient found in some over the counter cold remedies and appetite suppressants that was on the market for 50 years. Critics have questioned the safety of PPA for decades, but it was not until after a five-year Yale University study of men and women that PPA was associated to a significant increase in the risk of hemorrhagic strokes, especially amongst young women. On November 6, 2000, following the publication of the PPA study, the FDA announced the PPA recall.

A hemorrhagic stroke is bleeding into the brain or into tissue surrounding the brain that has irreversible effects and the inability to predict the serious condition. Hemorrhagic strokes are often deadly and can leave the survivors disabled. The consumer health warning issued by the FDA had an unusually strong tone, showing the seriousness of the condition, warning "We suggest you stop taking the drug immediately and use an alternative.

If you have taken products containing PPA and would like more PPA lawsuit information, please CONTACT US to speak with a PPA attorney.

Risk of hemorrhagic stroke in women significantly increases when taking PPA containing medicines

Researchers at the Yale University School of Medicine 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. Men may also be at risk for hemorrhagic strokes, but the FDA said there were not enough men studied to confirm if they are or are not at risk.

Why is PPA unsafe when this product has been in use for many years?

On May 11, 2000, FDA received results of a study conducted by scientists at Yale University School of Medicine that showed an increased risk of hemorrhagic stroke (bleeding of the brain) in people who were taking PPA. PPA has been used for many years and a very small number of people taking the drug have had strokes. The Yale study helped show that the number of people having strokes when taking PPA was greater than the number of people having strokes who were not taking PPA. Although the risk of hemorrhagic stroke is very low, FDA has significant concerns because of the seriousness of a stroke and the inability to predict who is at risk. Because of continued reports to the FDA of hemorrhagic stroke associated with PPA and the results of the Yale study, we now feel that the risks of using PPA outweigh the benefits and recommend that consumers no longer use products containing PPA. (from the FDA, 11-6-00)

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CBS News Medical Correspondent Elizabeth Kaledin reports on the FDA's PPA warning

  

Before the U.S. government warned Americans of the dangers of PPA due to its link to hemorrhagic strokes, about 6 billion doses of PPA were sold in the U.S. every year, with the majority of drugs not requiring a prescription

PPA Recall

The FDA contains records showing there were 44 cases of hemorrhagic stroke among PPA users in the past 30 years with most of them being young women with a median age of 35 . . . read more

Hemorrhagic Stroke

Strokes are the third leading cause of death in the U.S. today, and even though the risk of dying from a stroke is less than half of what it was 20 years ago, a hemorrhagic stroke is still often deadly and can leave survivors disabled . . . read more

About PPA

The FDA requested manufacturers of products containing PPA voluntarily discontinue marketing for them and for consumers to find alternative medications . . . read more

 



PPA MORE DANGEROUS FOR WOMEN

PPA has more dangerous effects on women according to a report from the General Accounting Office. The report found in nearly half of the cases of PPA health risks that women had a greater risk of developing life threatening conditions like a hemorrhagic stroke then men. Part of the reason is because more women than men took the drugs containing PPA. In certain drugs containing PPA that were prescribed to men and women more evenly physiological differences between the two sexes showed there were higher incremental risks to women, including in withdrawn hypertension drug Posicor, anhtihistamines Seldane and Hismanal, and heartburn drug Propulsid.

Hemorrhagic strokes affect not just the elderly

The FDA estimated PPA could be to blame for 200-500 hemorrhagic strokes in people under the age of 50.
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