Plavix has recently been linked to serious, life-threatening side effects, including internal bleeding, gastrointestinal hemorrhage, stroke, and death. Used in combination with aspirin, Plavix may double your risk of a severe bleeding event, including bleeding in the brain.
NEW: Plavix Bleeding Study Ended
Plavix and aspirin are both blood-thinning medications, usually prescribed to reduce a person’s risk of developing a blood clot that could cause a stroke or heart attack. Recently, a clinical trial investigated whether combining Plavix and aspirin would further decrease a person’s risk of suffering serious injury. Specifically, the researchers were studying the incidence of “subcortical” strokes, which are strokes caused by blood clots in the small vessels in the brain.
Over 3,000 patients who were at risk of recurrent strokes participated in the study, which was conducted by the Centers for Disease Control (CDC) in conjunction with the National Institute of Neurological Disorders and Stroke (NINDS). The findings were startling:
- 6.5% of Plavix-aspirin users experienced a serious bleeding event, compared with 3.3% of aspirin-only users.
- 5.8% of Plavix users died, compared to only 4.1% of aspirin-only users.
The study found that people who used Plavix with aspirin were twice as likely to have a serious bleeding event and more likely to die, prompting the researchers to prematurely end the study because the risk was unacceptably high. Patients were also far more likely to suffer cardiovascular injury, permanent disability, and death.
Cerebral Bleeding and Hemorrhage
Cerebral hemorrhage, or bleeding in the brain, occurs when a blood vessel bursts inside the brain. It may occur spontaneously or be caused by a blood clot that increases pressure on a weak vessel. Though symptoms may appear slowly, it usually occurs very suddenly — and can cause death within hours. Bleeding in the brain can cause hemorrhagic stroke, which accounts for 8-13% of all strokes. During this event, blood pools on the brain and causes cells to die. Stroke is the leading cause of disability and the third leading cause of death in the U.S.
Signs & Symptoms of Cerebral Bleeding
If you are at risk of stroke, you should know the symptoms of cerebral bleeding. 40-50% of people will experience alterations in the level of consciousness, nausea, vomiting, and headaches. About 6-7% will experience seizures.
- Abnormal sense of taste
- Change in alertness — feeling sleepy, stuporous, or going unconscious
- Difficulty speaking or understanding speech
- Difficulty swallowing
- Difficulty writing
- Loss of coordination or balance; falling
- Loss of motor skills — including hand tremors, difficulty moving a body part, weakness
- Nausea, vomiting
- Numbness or tingling, abnormal sensation
- Vision changes — blurry vision, double vision, eyelid drooping, uncontrollable eye movements
If you experience any of these symptoms, call 911 to contact an emergency physician immediately. You may be experiencing the first symptoms of a stroke.
Cerebral Bleeding Treatment
Any type of bleeding in the brain requires immediate emergency intervention. The type of treatment will depend on the severity of the bleeding and the location. Usually the person will be placed on a respirator, and a surgeon will make an opening in the skull to relieve pressure. Hemorrhages caused by a torn artery require immediate decompression of the cranial chamber to release the blood and repair damaged blood vessels.
Brain damage caused by intra-cranial bleeding cannot be repaired. A person who has been severely paralyzed or is in a coma after a hemorrhagic stroke will need rehabilitative care, including speech therapy and physical therapy. They may also need to live in a long-term nursing home.
What is the problem with Plavix?
Plavix is prescribed to people who are are at risk of recurrent strokes or heart attacks caused by blood clots. Blood clots are formed when platelets stick together. If a blood clot is pumped through the bloodstream (called an “embolism”) it can become trapped in the arteries that supply blood to the heart, brain, or lungs, causing a heart attack or stroke. The active ingredients in Plavix inhibit an enzyme that is necessary for blood platelets to stick together.
FDA Research & Safety Warnings
- Food and Drug Administration Warning Letter, which was sent to the makers of Plavix regarding misleading TV ads that “make representations and/or suggestions about the efficacy of Plavix, but fail to communicate any risk information associated with the use of this drug.”
- A study conducted by the New England Journal of Medicine (NEJM), comparing Plavix and aspiring, investigated the claim that Plavix was “easier on a person’s stomach” than aspirin. Actually, Plavix-users aretwelve times likelier to develop stomach ulcers, gastrointestinal bleeding, and cerebral bleeding.
- Research conducted by The Centers for Disease Control (CDC) found that the active ingredient in Plavix is ineffective, when Plavix is combined with popular medications such as Prilosec, Nexium, Prevacid, or Aciphex, and others. A person taking both medications would have very little protection against blood clots.
Other Plavix Side Effects
- Thrombotic Thrombocytopenic Purpura
- Gastrointestinal bleeding
- Bone Marrow Damage
- Heart attack