Plavix (clopidogrel bisulfate) has been linked to serious, life-threatening side effects, including internal bleeding, cerebral bleeding, gastrointestinal bleeding, heart attack, stroke, ulcers, brain hemorrhages, Thrombotic Thrombocytopenic Purpora (TTP), and death. Recently, a study found that combining Plavix and aspirin significantly increases a person’s risk of serious bleeding.
UPDATE: Bleeding Risk Increases When Common Painkillers Mixed with Blood-Thinners
November 18, 2014 — Combining common painkillers with blood-thinning drugs could significantly increase the risk of bleeding and blood clots for people with atrial fibrillation. Click here to read more.
November 17, 2014 — The FDA has issued a Safety Communication after the New England Journal of Medicine published a study linking the long-term use of Plavix in patients with coronary stents to an increased risk of bleeding and death, but a lower risk of blood clots, heart attack, and stroke. Click here to read more.
June 20, 2012 — More than 80 Plavix lawsuits have been filed in New York and Illinois in the last few weeks. Plaintiffs allege that they were not warned about the risk of side effects, that they were misled into believing that Plavix was more effective than aspirin, and that they were not warned that Plavix is not effective for some groups of people. Click here to read more.
Safety Update: Bleeding Study
The use of Plavix and aspirin doubles the risk of death, heart attack or stroke in people with no history of heart disease.
The National Institute of Neurological Disorders and Stroke (NINDS) has halted its stroke-prevention study, after finding that combining Plavix and aspirin significantly increased a user’s risk of bleeding and death.
- 6.5% of Plavix/aspirin combination users experienced bleeding, compared with 3.3% of aspirin-only patients.
- 5.8% of Plavix/aspirin combination users died, compared with 4.1% for aspirin-only patients.
The researchers have been studying 3,000 people since 2003. They were hoping the drug combination would prevent strokes for patients who experienced recurring strokes in the brain (known as “subcortical” strokes).
The Wall Street Journal reported: “For stroke … the combination does not offer any protection, but does put you at increased risk for bleeding,” said Walter Koroshetz, deputy director of NINDS, reported the Journal.
What is the problem?
Plavix is a widely used blood-thinning medication co-marketed by Bristol-Myers Squibb Co. and Sanofi SA. It was approved by the FDA in 1997 for the prevention of blood clots, heart attacks, and stroke. Plavix is the second best-selling drug in the world (first place goes to Pfizer’s Lipitor, used to lower cholesterol). It generated $8.8 billion in global sales in 2010.
- In 2009, the FDA sent a warning letter because the Plavix advertisements 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.”
- A study published in the Archives of Internal Medicine, conducted by the U.S. Centers for Disease Control (CDC) found that Plavix-users who also used Prilosec, Nexium, Prevacid, or Aciphex (known as Proton Pump Inhibitors (PPIs)) were significantly more likely to be re-admitted to a hospital — PPIs make Plavix less effective.
- A study in the New England Journal of Medicine found that Plavix-users are 12 times more likely to develop recurrent ulcers, gastrointestinal bleeding, and cerebral bleeding than a combination of aspirin and a heartburn medication.
Plavix Lawsuit Filed
Lawyers are reviewing potential lawsuits for people who have been injured or died after using Plavix, claiming that the drug-makers “rushed the drug to market and then launched an aggressive marketing campaign touting Plavix as providing greater cardiovascular benefits than aspirin, while being safer and easier on a person’s stomach.”
The lawsuit contends that these claims are false, and the drug-makers knew about the serious side-effects, but they intentionally withheld important safety information. Furthermore, although the drug-makers were warned by the FDA to correct their advertising campaign, they did not comply. These actions misled countless consumers, leading to injury and death.
Plavix Side Effects
Serious side effects include:
- Internal Bleeding
- Gastrointestinal Bleeding
- Cerebral Bleeding or Hemorrhage
- Thrombotic Thrombocytopenic Purpura (TTP)
- Bone Marrow Damage
- Heart attack