Research shows the platelet-inhibiting drug clopidogrel bisulfate—sold under the brand name Plavix—causes heart-related side effects. And—for many users—it proves largely ineffective.
The Rottenstein Law Group, a Plavix law firm, compassionately advocates for those who have suffered Plavix side effects. If you’ve taken Plavix and believe it harmed you, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Plavix recalls and Plavix class action lawsuits.
What Is Plavix and What Is It Prescribed For?
Plavix is the brand name for the drug clopidogrel bisulfate. Made and sold by French pharmaceutical company Sanofi Aventis S.A. and American pharmaceutical company Bristol-Meyer Squibb, Inc., this prescription medication is used to prevent blood clots caused by coronary artery disease, heart attacks, strokes, and peripheral artery disease. Plavix received U.S. Food and Drug Administration (FDA) approval in November 1997, and the manufacturers sell it in 75 mg and 300 mg oral tablets, taken daily often in combination with aspirin.
A member of the thienopyridine class of anti-platelet drugs, Plavix works by binding to a receptor on platelet cell membranes called “adenosine diphosphate” (ADP). The specific ADP receptor subtype it binds to is called “P2Y12.” The ADP receptor is responsible for allowing platelets to clump together and cross-link, and by interfering with that process Plavix prevents blood clots.
Plavix Might Cause Life-Threatening Side Effects and Be Ineffective
Plavix Bleeding Side Effects
Like all anti-platelet drugs, Plavix’s drug label carries a “General Risk of Bleeding” entry in its “Warnings and Precautions” section. In November 2010, the Archives of Internal Medicine published an article that compared emergency room visits by people who were taking Plavix and aspirin with people who were taking another, older blood thinner, warfarin. The authors found a risk ratio of 1.46:1 between Plavix and aspirin versus warfarin due to acute hemorrhages, a finding they deemed clinically significant. Symptoms of hemorrhage include:
- Unusual bleeding in the gums;
- Frequent nose bleeds;
- Heavier-than-normal menstrual or vaginal bleeding;
- Severe or uncontrollable bleeding;
- Blood in urine (pink or brown color);
- Blood in stool (red or black);
- Bruises caused by unknown events;
- Bruises that increase in size;
- Coughing up blood or blood clots; and
- Vomiting blood or vomit that resembles coffee grounds.
Plavix Thrombotic Thrombocytopenic Purpura Side Effects
Plavix can also cause Thrombotic Thrombocytopenic Purpura (also called “Moschcowitz syndrome”) (TTP). TTP is a blood coagulation disorder in which small blood clots form in the blood stream and can damage internal organs. Symptoms include:
- Thrombocytopenia (low platelet count), which can lead to bruising;
- Microangiopathic hemopytic anemia, a loss of red blood cells;
- Neurological symptoms: hallucinations, unusual behaviors, altered mental states, strokes, and headaches; and
- Kidney failure.
TTP is a dangerous condition and can be fatal in 10 percent to 20 percent of cases.
Plavix Use with Prilosec Side Effects
Beginning in 2009, the FDA published a series of Drug Safety Communications warning the public that Plavix use by those taking the proton pump inhibitor-class (PPI) heartburn medication omeprazole (Prilosec) might see a reduced effectiveness of Plavix by a factor of one half. Doctors often recommend Plavix users take Prilosec because Plavix can cause stomach bleeding and other gastrointestinal discomfort. Studies showed that Prilosec interferes with Plavix’s ability to transform into its active ingredient. If the drug is less effective in patients, they might suffer adverse side effects common to drug underdosing, especially heart attacks, strokes, and possibly death. Most other PPIs do not cause reduced Plavix effectiveness.
Plavix Might Be Ineffective in Some Users
In March 2010, the FDA added a “black box” warning to the Plavix drug label, which is its most serious product warning. Researchers had discovered that many people are deficient in the liver enzyme (CYP2C19) required to metabolize Plavix. According to the black box warning, people who are poor metabolizers “exhibit higher cardiovascular event rates than do patients with normal CYP2C19 function.” Poor metabolizers of Plavix might suffer adverse side effects similar to trug underdosage, such as heart attacks, strokes, and death. According to an article in the August 2009 issue of the Journal of the American Medical Association, the gene responsible for poor Plavix metabolization is present in roughly one third of the population, though the rate varies based on ethnic origin.
Plavix Lawsuits Pending throughout the United States
Since at least 2009, people have filed Plavix lawsuits against Sanofi and Bristol-Myers Squibb for many reasons. Most of the lawsuits allege that Plavix is no more effective than aspirin alone, causing them to suffer the above-mentioned Plavix side effects needlessly. Others allege Plavix caused them to develop TTP. In December 2011, the U.S. Judicial Panel on Multidistrict Litigation (MDL) declined to centralize all pending federal-level Plavix lawsuits before one federal district court because there were only twelve litigants involved, and most of their cases were before a single federal judge in New Jersey. In January 2012, 72 people filed Plavix lawsuits in Illinois state court, though most Plavix lawsuits are located in New Jersey state court in that state’s version of MDL.
RLG’s Plavix Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Plavix lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Plavix lawsuit on your behalf if necessary. RLG will also keep you up to date on any Plavix class action lawsuits, FDA Plavix warnings, and Plavix FDA recall announcements. If you have taken Plavix and believe it harmed you, contact RLG today.