Plavix Gastrointestinal Bleeding Lawsuit

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Recent studies indicate that the popular anti-clotting drug Plavix (clopidogrel bisulfate) may be linked to an increased risk for severe bouts of gastrointestinal bleeding and other serious side effects. Signs and symptoms of Plavix-induced gastrointestinal bleeding may include fatigue, weakness, abdominal pain, and vomiting blood. Unfortunately, episodes of gastrointestinal bleeding caused by Plavix can have fatal outcomes.

What’s the problem?

First approved by the U.S. Food & Drug Administration (FDA) in 1997, Plavix is a widely used clotting agent typically prescribed for the prevention of blood clots and to reduce the risk of heart attacks and strokes. With annual sales approaching $4 billion, Plavix is currently the sixth best-selling drug in the United States.

Within a year of its release, federal health regulators began expressing concern with claims made by Plavix’s manufacturers, Bristol-Myers Squibb/Sanofi Pharmaceuticals. The FDA charged the companies with falsely claiming that Plavix was more effective than aspirin at treating heart disease.

Making matters worse, research published in the New England Journal of Medicine (NEJM) found that individuals taking Plavix were 12 times more likely than those taking aspirin and a proton pump inhibitor heartburn drug to suffer from severe gastrointestinal bleeding and chronic ulcers. Additionally, the study revealed that Plavix and aspirin together offered consumers absolutely no benefit over a standard low-dose aspirin regimen. The research also linked Plavix to an increased risk for moderate and serious internal bleeding. The study’s authors concluded that the serious risks associated with the drug could not be justified by its marginal overall benefits.

Gastrointestinal Bleeding Signs and Symptoms

The gastrointestinal (GI) tract consists of the esophagus, stomach, small intestine, large intestine, colon, rectum and anus. GI bleeding can occur in any one or more of these areas, but is typically divided into:

  • Upper GI bleeding (esophagus, stomach, and the first part of the small intestine)
  • Lower GI bleeding (small intestine, large intestine, bowels, rectum or anus)

Signs and symptoms of Plavix-induced gastrointestinal bleeding may include:

  • dark, tarry stools
  • large amounts of blood passed from the rectum
  • small amounts of blood in the toilet bowl, on toilet paper, or in streaks on stool
  • vomiting blood

GI Bleeding Treatment Options

According to the Mayo Clinic, depending on the source of the problem, there are a variety of treatment options available for individuals suffering from gastrointestinal bleeding:

  • Endoscopic thermal probe – used to treat bleeding ulcers and other bleeding issues by coagulating the blood vessel or abnormal tissue.
  • Argon plasma coagulation and radiofrequency ablation – thermal technique used to treat abnormal blood vessels in the stomach, small intestine and colon.
  • Endoscopic clips – synthetic clips used to close a bleeding vessel or other defective tissue.
  • Endoscopic band ligation – technique that uses special rubber bands to treat bleeding hemorrhoids and bleeding vessels in the esophagus.
  • Endoscopic cryotherapy – freezes abnormal blood vessels in the stomach.
  • Endoscopic intravariceal cyanoacrylate injection – uses a special glue to treat difficult breathing from abnormal blood vessels in the stomach.
  • Angiographic embolization – injects particles directly into the blood vessel to stop bleeding.


Because GI bleeding may be indicative of a serious underlying disease, failure to seek prompt treatment can result in adverse complications and permanent damage. Once the underlying issue is conclusively diagnosed, it is important that the patient follows the treatment plan that his or her doctor designs to reduce the risk of potential complications, which may include:

  • anemia (low red blood cell count)
  • need for blood transfusion
  • shock
  • spread of cancer
  • spread of infection

Each year, more than 300,000 patients are hospitalized with gastrointestinal bleeding. Approximately 150 out of every 100,000 people experience some form of GI bleeding during the course of their lives. Nearly three-quarters of GI bleeding incidents occur in the upper GI tract, and roughly half of all GI bleeds are caused by peptic ulcer disease. The mortality rate for gastrointestinal bleeding currently stands at around 10%, and this percentage increases with age as patients begin to have multiple contributing factors. In patients under the age of 50, however, the most common cause of GI bleeding is hemorrhoids.

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