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Plavix (Clopidogrel) is an oral, antiplatelet agent used to prevent blood clots in coronary artery disease, peripheral vascular disease, and cerebrovascular disease. It is a thienopyridine-class antiplatelet agent. It is marketed by Bristol-Myers Squibb and Sanofi under the trade name Plavix. Plavix was first approved by FDA on November 17, 1997. The drug works in an irreversible manner preventing a receptor called P2Y12, adenosine diphosphate (ADP) chemoreceptor on platelet cell membranes.
New England Journal of Medicine showed that patients who were on Plavix were 12 times more likely to experience GI bleed and chronic ulcers than those taking Aspirin. The research revealed that Plavix and Aspirin if combined offered no benefit to the patients. Plavix increased risk for moderate and serious bleeding. The study emphasized that the cost and risks of Plavix could not justify its use for the prevention of coronary artery disease and heart attack.
A study conducted by US Centers for Disease Control found that patients who used Prilosec, Nexium, Prevacid before Plavix were more prone to get re-admitted to hospital thus making Plavix less effective.
Serious complications faced till date
- Easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoints spots under skin
- Bloody or tarry stools, blood in urine blood in urine
- Internal bleeding - gastrointestinal bleed, intracranial bleed
- Heart attacks
- Thrombotic thrombocytopenic purpura (TTP)
- Sudden numbness or weakness, especially on one side of the body
- Bone marrow damage
In 1998, the Food and Drug Administration reproached the manufacturers for advertising Plavix use in patients receiving stents. The dosage advised by manufacturers was four times higher than what had been approved as safe in initial clinical trials.
The Plavix warning letter criticized the failure to disclose any of the risks associated with Plavix.
In May 2001, a Plavix warning letter warned the manufacturers again to stop making unsubstantiated claims about Plavix. Advertisements selectively presented the most favorable information while ignoring unfavorable data. Claims that Plavix was better than Aspirin were present without contextual information necessary to physicians to interpret the data they presented
In 2009, the FDA issued a black box warning for Plavix. In March 2010, the FDA issued another Black box warning for Plavix and its lack of effectiveness for patients who are poor metabolizers.
Evidence to be looked for in potential cases
- 1. Usage of Plavix in Pharmacy records
- 2. Duration of Plavix usage
- 3. Indication for Plavix usage in Medical records
- 4. Complication and their treatment after Plavix usage
Medical Record Review and claim validation of Plavix case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.