Plavix (clopidogrel) — the world’s best-selling prescription medication for preventing strokes and heart attacks — has been linked to Thrombotic Thrombocytopenic Purpura (TTP), a bleeding disorder caused by blood clots forming in the small blood vessels.
Safety Warning: Plavix Study Halted
Because Plavix discourages the formation of blood clots, it is usually prescribed to people who have had strokes and heart attacks as a preventative medication. However, new research has discovered that if you combine Plavix with aspirin, you are twice as likely to suffer from a serious bleeding event, and more likely to die. This new research adds further evidence to the growing body of research that shows Plavix has catastrophic side effects.
The research, funded by the Centers for Disease Control (CDC) and the National Institute of Neurological Disorders and Stroke, hoped that the combination of Plavix plus aspirin would reduce the incidence of strokes caused by small blood clots in the brain. These strokes are called “subcortical strokes” and are often recurring, causing serious debilitation and death. The study followed more than 3,000 people — some were taking aspirin-only treatment, and some were combining Plavix with aspirin. The findings were alarming: People who took Plavix plus aspirin were significantly more likely to experience internal bleeding, cardiovascular injury, and death.
- 6.5% of Plavix-aspirin users experienced a serious bleeding event. 5.8% of these users died.
- In comparison, only 3.3% of aspirin-only users experienced bleeding, and 4.1% died.
Is Plavix Dangerous?
Plavix is produced by Bristol-Myers Squibb and Sanofi-Aventis SA. Sales top $8 billion every year. Since its approval, it has become second most popular drug in the entire world (after Lipitor, a cholesterol-lowering medication). It is used by millions of people to prevent heart attacks and strokes caused by blood clots. Plavix works by inhibiting an enzyme in the blood involved in clotting. It prevents platelets in the blood from attaching to each other, thus forming a blood clot. Sometimes, blood clots form in the body, break loose, and start to move in the blood stream. This is called an embolism and is extremely dangerous. If an embolism becomes trapped in a major internal organ, such as the heart, lungs, or brain, it can suddenly lead to death.
Unfortunately, Plavix is no more effective than aspirin at preventing clot-related heart attacks and death — but it has severe side effects.
The pharmaceutical company that manufactures and markets Plavix is facing several lawsuits from consumers who have been harmed by the medication, including people who have suffered Thrombotic Thrombocytopenic Purpura (TTP). The lawsuits contend that the drug-makers rushed Plavix to the market without conducting sufficient safety studies, and falsely promoted Plavix as superior to aspirin because it was easier on the stomach — a claim that is contradicted by research, which shows that Plavix significantly increases a person’s risk of developing an ulcer. Some people are angry because the drug-makers did not adequately warn them about the risks, and they later suffered severe side-effects.
What is the evidence?
- The Food and Drug Administration (FDA) sent the marketers of Plavix a safety warning letter after finding the commercials 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 (NEJM) compared Plavix to aspirin, and found significantly increased side effects on a person’s stomach. Plavix-users are12 times more likely to develop ulcers, gastrointestinal bleeding, and cerebral bleeding.
- The Centers for Disease Control (CDC) found that many popular drugs (Prilosec, Nexium, Prevacid, or Aciphex, among others) contain chemicals that made Plavix inactive when they are used together. The result is that someone taking both these medications would not be protected against strokes and heart attacks.
What is Thrombotic Thrombocytopenic Purpura (TTP)?
Since Plavix was approved, at least 12 reports of of Plavix-induced TTP have been reported. One person has died. It is estimated that one in every 250,000 people using Plavix has developed TTP.
Thrombotic Thrombocytopenic Purpura (TTP) is a disease affecting the small blood vessels, in which small blood clots form all over the body. If left untreated, TTP can become a chronic condition and lead to death, but advances in modern medicine have greatly improved the prognosis for most people who develop TTP. Usually, the most obvious symptom of TTP are small, purple spots on the skin — small hemorrhages just under the skin. These purple spots are called “purpura.”
Plavix causes TTP because it inhibits an enzyme in the blood necessary for clotting, which prevents platelets from sticking together. Sometimes, this reduces the amount of platelets in the bloodstream. When the body needs to form blood clots (such as when you get a cut or a bruise), there are not enough platelets available to form the clots needed to stop bleeding.
Signs and Symptoms of Thrombotic Thrombocytopenic Purpura (TTP)
TTP can be life-threatening if blood clots begin to form in the small blood vessels in the brain. The first signs that TTP is affecting the brain are neurological symptoms: personality changes, headaches, confusion, and slurred speech. When these blood clots form in the heart, cardiovascular problems can occur, such as an abnormal heart rhythm.
Other symptoms include:
- malaise
- fever
- headaches
- diarrhea
- confusion
- difficulty speaking
- transient paralysis
- numbness
- bleeding into the skin or mucus membrane
- changes in consciousness
- fatigue
- heart rate over 100 beats per minute
- pallor
- purplish spots in the skin produced by small bleeding vessels near the surface of the skin
- shortness of breath
- changes in speech patterns
- weakness
- yellowish color to the skin (jaundice)
Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
If TTP is left untreated, if can progress to a life-threatening stage. Treatment involves donor plasma transfusions. A patient will need to visit a hematologist to undergo this procedure. The transfusions of plasma replaces the missing enzymes that are necessary for normal blood clotting to occur.
First, the procedure involves a blood draw. The patient’s blood is taken, and processed in a machine that removes the patient’s plasma. A donor’s plasma is then replaced, which provides the patient with new blood that includes missing enzymes. After the transfusion, the patient will go home.
The treatment will need to be repeated several times. Sometimes, improvement is seen in as little as three days, though it may take up to ten days, and require 10-15 transfusions. Five plasma transfusions will be performed during the first 10 days of treatment.
People who undergo plasma transfusions usually see a reduction in neurological symptoms, a normal hemoglobin count, increased platelets, and normal creatinine levels within a few days. Most people with TTP who undergo plasma transfusions recover completely. However, if it has been left untreated for a long period of time, TTP can become chronic or lead to death.
Other Plavix Side Effects
- Gastrointestinal bleeding
- Cerebral bleeding
- Bone Marrow Damage
- Heart attack
- Stroke
- Ulcers
- Death
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