Plavix (clopidogrel) is a best-selling blood-thinning medication, approved for the prevention of strokes and heart attacks caused by blood clots, has serious side effects — including heart attack, stroke, ulcers, brain hemorrhages, Thrombotic Thrombocytopenic Purpora (TTP), and death.
UPDATE: Plavix Internal Bleeding Study Halted
The National Institute of Neurological Disorders and Stroke suddenly halted its study of nearly 3,000 people on Plavix and aspirin after finding alarming results. The hope was that the drug combo would decrease a patient’s risk of recurrent strokes in the brain — known as “subcortical” strokes, because they occur in the small vessels. Instead, patients who took Plavix and aspirin were twice as likely to have a bleeding event. Also, they had an increased chance of cardiovascular injury and death.
- 6.5% of Plavix-aspirin users experienced hemorrhage, compared with 3.3% of aspirin-only users.
- 5.8% of Plavix-aspirin users died, compared with 4.1% of aspirin-only users.
A report in The Wall Street Journal quoted Walter Koreoshetz, deputy director of the study: “For stroke … the combination does not offer any protection, but does put you at increased risk for bleeding.”
What is the problem?
Plavix is a blood-thinner intended to prevent strokes and heart attacks by preventing the formation of clots. It inhibits platelets in the bloodstream from sticking together, which deters the formation of clots. Clots can become deadly if they float in the bloodstream (an “embolism”) and become trapped in the heart, brain, lungs, or other major internal organs. An embolism can cause heart attack, stroke, and death. In 2007, the FDA approved Plavix for the prevention of strokes and heart attacks caused by embolisms.
- The Food and Drug Administration (FDA) sent Bristol-Myers Squibb and Sanofi-Aventis a warning letter because television ads promoting the drug 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 published new medical research that found compared Plavix and aspirin, and found that Plavix users aretwelve times more likely to develop ulcers and severe internal bleeding — including gastrointestinal bleeding and cerebral bleeding.
- The Centers for Disease Control (CDC) found that Plavix combined with Prilosec, Nexium, Prevacid, or Aciphex, and several other common drugs, de-activated the active ingredient in Plavix, making it ineffective for preventing strokes.
What types of Bleeding are Caused by Plavix?
Symptoms of bleeding may occur anywhere in the abdomen — if they occur in the gastrointestinal tract, bleeding usually occurs in the upper intestine or lower intestine. Each individual case will depend where the person is bleeding, the severity of the hemorrhage, and how much blood has been lost.
Sudden bleeding symptoms include: vomiting blood, bloody bowel movements, or black, tarry stools that may resemble “coffee grounds.”
If a person is bleeding internally, they will probably exhibit the following symptoms:
- Shortness of breath
- Abdominal pain
- Pale appearance
Internal bleeding is an emergency situation that requires immediate assistance.
Cerebral Bleeding or Hemorrhage:
When a blood vessel bursts in the brain (a type of stroke), lifelong debilitating injury or death can occur very quickly. If you experience any of the below symptoms, contact an emergency physician immediately. The blood in the brain irritates the tissue in the brain, causing it to enlarge (“cerebral edema”) and may coagulate in a pool on the brain (a “hematoma”). This excess fluid increases pressure within the skull, reducing circulation, and may cause the death of brain cells or the death of the patient. Sometimes, parts of the brain die but the patient survives. The symptoms listed below can happen suddenly, or develop over time — depending on the severity and suddenness of the bleeding.
- Sudden severe headache
- Weakness in an arm or leg
- Nausea, vomiting
- Changes in vision
- A “tingling” or numb sensation
- Slurred speech
- Loss of motor skills — hand tremors, loss of balance, difficulty writing or reading, difficulty swallowing
- Abnormal sense of taste
- Loss of consciousness
If you exhibit any of the above symptoms, contact an emergency physician immediately.
Other Plavix Side Effects
- Thrombotic Thrombocytopenic Purpura (TTP)
- Bone Marrow Damage
- Heart attack