Thrombotic Thrombocytopenic Purpura (TTP) has been linked to Plavix (clopidogrel), the world’s best-selling blood-thinning medication, prompting lawsuits against drug-makers
What is the problem with Plavix?
Plavix received FDA approval in 2007 for the prevention of heart attacks, strokes, and other ailments caused by blood clots. It is an anti-platelet medication, which means that it prevents blood clots by inhibiting platelets from attaching to each other. If a blood clot forms, it may move through the bloodstream (called an “embolism”), and get stuck in a major internal organ such as the heart, lungs, or brain.
The problem with Plavix is that it is no more effective at preventing heart attacks or strokes than aspirin, but carries catastrophic side effects.
The drug-makers are facing several lawsuits, including lawsuits from people who suffered Thrombotic Thrombocytopenic Purpura (TTP) injury as a direct result of taking Plavix. People who have suffered serious side effects are now seeking legal remedy.
- The Food and Drug Administration (FDA) found that the Plavix commercials were misleading “because they make representations and/or suggestions about the efficacy of Plavix, but fail to communicate any risk information associated with the use of this drug.”
- The New England Journal of Medicine researched the effect of Plavix on a person’s stomach (comparing it to aspirin), and found that Plavix-users are12 times more likely to suffer from stomach ulcers, gastrointestinal bleeding, and cerebral bleeding.
- The Centers for Disease Control (CDC) research of Plavix-users who were also taking Prilosec, Nexium, Prevacid, or Aciphex, to name a few. The researchers found that these common, popular drugs made Plavix inactive — someone taking both these medications would have had little protection against strokes and heart attacks.
What is Thrombotic Thrombocytopenic Purpura (TTP)?
Since Plavix was approved in 1997, at least twelve cases of TTP have been reported, including one death. The estimated incidence of Plavix-induced TTP is about one in every 250,000 patients.
TTP is a blood disorder in which blood clots form in the small blood vessels. Though they may form all over the body, usually the most notable sign is when they form in the skin, causing bleeding — seen as purple-colored spots called “purpura.” The problem is that Plavix inhibits a certain enzyme in the blood that is involved in clotting. In some patients, it reduces the number of platelets in the blood. When there are not enough platelets in the blood, the body is unable to form blood clots when it needs to (such as when you get a bruise).
Signs and Symptoms of Thrombotic Thrombocytopenic Purpura (TTP)
TTP is caused by blood clots forming in the small vessels all over the body. If they are forming in the brain, they can result in neurological changes: personality changes, headaches, confusion, and slurred speech. If they form in the heart, cardiovascular problems can occur, such as an abnormal heart rhythm.
Other symptoms include:
- difficulty speaking
- transient paralysis
- bleeding into the skin or mucus membrane
- changes in consciousness
- heart rate over 100 beats per minute
- purplish spots in the skin produced by small bleeding vessels near the surface of the skin
- shortness of breath
- changes in speech patterns
- yellowish color to the skin (jaundice)
Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
When TTP has progressed to a severe, life-threatening stage, the therapy of choice is a plasma infusion. A patient will receive several transfusions of plasma from donors. This donor plasma removes the antibodies preventing clotting, and also replaces the missing enzymes.
A person who undergoes this treatment will have their blood drawn. The patient’s blood will be processed in a machine to remove the plasma, and the remainder will be saved. Then the donor plasma will be added, and the blood will be re-injected into the person.
Usually, at least five plasma exchanges are performed in the first ten days of treatment. Improvement will typically be seen within the first 10-15 transfusions. Prognosis is usually quite good, and patients can expect to have reduced neurological symptoms, normalization of hemoglobin, platelet count, and creatinine within a few days of treatment.
This type of treatment has greatly improved the prognosis for people who have Thrombotic Thrombocytopenic Purpura. Most people recover completely. However, if it has been left untreated for a long period of time, it can become chronic or lead to death.