Plavix Internal Bleeding Lawsuit

Plavix (clopidogrel) — the most popular blood-thinning medicine in the world — has been linked to internal bleeding and other serious side effects, such as heart attack, stroke, ulcers, brain hemorrhages, Thrombotic Thrombocytopenic Purpora (TTP), and death. A new study was suddenly halted when researchers discovered that combining Plavix with aspirin doubles a person’s risk of internal bleeding.

UPDATE: Plavix Internal Bleeding Study Halted

This was the finding of a recent study conducted by the National Institute of Neurological Disorders and Stroke, which has tracked 3,000 people taking medication to reduce their risk of stroke since 2003. In the study, one group of people were taking both aspirin and Plavix. The researchers hoped that the combination of blood-thinners would reduce the patients’ risk of recurrent strokes in the small vessels in the brain — called “subcortical” strokes.

Instead, the researchers found that the patients were significantly more likely to experience internal bleeding, cardiovascular injury, and death. 6.5% of people taking Plavix and aspirin experienced hemorrhaging, and 5.8% died. In comparison, for the people only taking aspirin, 3.3% experienced a hemorrhage, and 4.1% died.

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 prescription anti-platelet medication. It works by inhibiting platelets in the bloodstream from sticking together, which prevents clots from forming. If a clot forms, breaks loose, and travels through the bloodstream (called an “embolism”) it may go to the heart, brain, or lungs, and severely damage these organs or cause death. Plavix received FDA-approved in 2007 as a preventative medication for people at high risk of strokes and heart attacks.

However, you should be aware that Plavix has some serious side effects. Several lawsuits accuse the manufacturers and marketers of rushing the drug to market, aggressively advertising Plavix as more effective than aspirin for preventing strokes and less harmful to the stomach — all while minimizing the serious risks. The FDA has warned that Plavix advertisements withhold important safety information and mislead consumers.

• The Food and Drug Administration (FDA) warned Plavix in a safety warning letter to marketers because the TV commercials advertising 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 Plavix users are12 times more likely to develop ulcers, gastrointestinal bleeding, and cerebral bleeding, compared to aspirin alone.
• The Centers for Disease Control (CDC) studied Plavix combined with several popular drugs (Prilosec, Nexium, Prevacid, or Aciphex, to name a few). The study found that these common medications made Plavix ineffective at preventing strokes.

What types of Bleeding are Caused by Plavix?

Gastrointestinal symptoms may occur in the upper intestine, lower intestine, or other parts of the abdomen. Symptoms will depend on the location of the bleeding and the amount of blood that has been lost. If you experience any of these symptoms while taking Plavix, seek emergency attention immediately.

Acute cases of gastrointestinal hemorrhage will include vomiting blood, bloody bowel movements, or black, tarry stools that may resemble “coffee grounds.” Symptoms associated with blood loss include:

• Fatigue
• Weakness
• Shortness of breath
• Abdominal pain
• Pale appearance

Cerebral Bleeding or Hemorrhage:

These life-threatening symptoms occur when an artery in the brain bursts — a type of stroke. The fluid irritates brain tissues, causes swelling (known as “cerebral edema”) and may pool into a mass (a “hematoma”), increasing pressure on the brain, reducing circulation, and causing death of brain cells. These symptoms may appear suddenly or develop over time, depending on the type of hemorrhage.

• 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.