HEMORRHAGIC STROKES

When announcing the FDA was taking steps to remove PPA from all prescription and over the counter cold remedies and weight loss products, the FDA stated that despite the relatively low incidence of hemorrhagic strokes they were more concerned with the serious nature associated with hemorrhagic strokes. The number of deaths that occur following a stroke has been cut in half from twenty years ago, but hemorrhagic strokes are still deadly and can leave survivors disabled. A hemorrhagic stroke occurs when an artery in the brain leaks or ruptures and the blood puts pressure on the surrounding brain tissue causing damage.

The percentage of actual over the counter adverse drug reactions that are sent to the FDA is between 5-10%, indicating as many as 510-1,020 cases of hemorrhagic stroke has occurred. Despite evidence showing the dangers associated to PPA, it was not until a decade later that the FDA announced they were beginning to take steps towards the PPA recall. This FDA PPA recall followed the completed 5-year Yale study that showed the link between PPA and hemorrhagic strokes.

The Yale PPA injury study, that was published in the New England Journal of Medicine, reported women ages 18-49 who took an appetite suppressant containing PPA was 16 times more likely to suffer a hemorrhagic stroke than other women. The women who used cold remedies containing PPA for the first time were found to have a threefold increased risk of hemorrhagic stroke. There were hundreds of prescription and over the counter drugs that were available containing PPA at the time the Yale PPA injury study was published, and about 6 billion doses of PPA was sold in the U.S. every year with the majority of the drugs not even requiring a prescription.

The results of the PPA injury study concerned the FDA enough to issue an unusually strong warning to PPA consumers stating, “We suggest you stop taking the drug immediately and use an alternative.” Hemorrhagic strokes poses such a serious risk because of the seriousness of the condition but also because there was no way to predict if a PPA patient had a higher risk of suffering a hemorrhagic stroke because it could strike without warning.

Symptoms of hemorrhagic strokes may include:

• Sudden numbness or weakness in the face or limbs, especially on one side of the body.
• Sudden trouble seeing in one or both eyes.
• Sudden mental confusion or trouble speaking or understanding speech.
• Sudden dizziness, loss of balance or trouble with walking.
• Sudden severe headache with no known cause.
• Treatment of hemorrhagic strokes may include:
• Surgery to remove blockages in clogged neck arteries
• Medication to dissolve blood clots in the brain that can be effective if treatment is started within a few hours after the stroke occurred.
• Rehabilitation to reduce dependence and improve physical ability.

Contact us for more information regarding your legal rights on hemorrhagic strokes and to speak with a PPA attorney.