Plavix

  • Plavix Medical Record Review & Outsourcing Services

The oral antiplatelet agent Clopidogrel was marketed jointly by Bristol-Myers Squibb Co. and Sanofi SA under the brand name Plavix. It is used to treat the formation of blood clots in peripheral vascular disease, cerebrovascular disease, and coronary artery disease. It belongs to the thienopyridine-class antiplatelet agent. Plavix works in an irreversible manner by blocking a receptor called P2Y12, adenosine diphosphate (ADP) chemoreceptor on platelet membranes. The U.S. Food and Drug Administration (FDA) approved the use of Plavix on November 17, 1997.

Plavix are film-coated tablets that are usually pink in color having a round biconvex shape. It comprises clopidogrel bisulfate. The pink film coating of the tablet comes along with hypromellose 2910, lactose monohydrate, ferric oxide, titanium dioxide, and triacetin. Carnauba wax is used for polishing this tablet. 

If the patient is taking plavix to prevent clots post stent implantation, then this medication can be taken with aspirin for few months after the procedure. This medication can’t be stopped in between before taking prior consultation from your doctor. 

Unless and until your doctor tells you that having grapefruit or grapefruit juice is safe, avoid intake of it while having plavix, as this food item can increase the chance of side effects along associated with this medication. 

New England Journal of Medicine showed that patients who were on Plavix were 12 times more likely to experience gastrointestinal bleed, (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 the risk of 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, and Prevacid before Plavix were more prone to get re-admitted to hospital thus making Plavix less effective.

Serious Alleged Injuries may include:

  • Easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under skin
  • Bloody or tarry stools, blood in urine
  • Internal bleeding - gastrointestinal bleed, intracranial bleed
  • Ulcers
  • Heart attacks
  • Strokes
  • Thrombotic thrombocytopenic purpura (TTP)
  • Sudden numbness or weakness, especially on one side of the body
  • Bone marrow damage
  • Death

FDA Safety Warnings:

  • In 2009, the FDA added information to the drug label about poor metabolizers of Plavix. The same year, the FDA also released warnings against using Plavix when the patient was on omeprazole, a proton pump inhibitor antacid stating that taking the two together can significantly reduce the effectiveness of Plavix.
  • In March 2010, the FDA issued a Black box warning to highlight the reduced effectiveness of Plavix in patients who are poor metabolizers of Plavix and recommend to the medical community to consider using other anti-platelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.

Legal Updates:

As of September 2017, more than 5,000 cases were pending across the country against BMS that included cases from Delaware, New York, New Jersey, and California. In 2013, MDL No. 2418 was established in the U.S. District Court for the District of New Jersey under U.S. District Judge Joseph R. Goodwin. Amongst a list of allegations, the plaintiffs allege negligence, false or misleading advertising, and wrongful death.

In June 2017, the U.S. Supreme Court announced a verdict in favor of BMS and dismissed 592 Plavix cases brought in California by people from other states. This left only 86 cases brought in California by Californians. The ruling limited cases to either the state where the company is located – in the case of BMS (New York) or where the plaintiffs reside. This left immediate and ongoing effects on other mass litigations across the country, involving other products and companies as well.

 

 

News:


 Oct 12, 2020: Plavix Plus Aspirin Linked To Bleeding Risk In TAVI Patients

On October 8, 2020,  a study was published in the New England Journal of Medicine where the researchers from the Netherlands indicated that patients with a transcatheter aortic valve implant (TAVI) who were administered with a combination of aspirin and Plavix stood twice the chance of increased bleeding risk over the patients given aspirin alone.

The oral antiplatelet agent Clopidogrel was marketed jointly by Bristol-Myers Squibb Co. and Sanofi SA under the brand name Plavix. It is used to treat the formation of blood clots in peripheral vascular disease, cerebrovascular disease, and coronary artery disease. The U.S. Food and Drug Administration (FDA) approved the use of Plavix on November 17, 1997.

The study involved a randomized, controlled trial of over 665 patients, out of which 331 were administered with aspirin alone, and 334 patients were given aspirin plus Plavix. The researchers found that 50, or 15.1% of aspirin-only patients suffered a bleeding event over a year, whereas the rates of death due to bleeding, strokes, and heart attacks among 89, or 26.6% of aspirin and Plavix patients were also a lot more similar.

The researchers concluded that patients undergoing TAVI who did not indicate oral anticoagulation, the incidence of bleeding, and the composite of bleeding or thromboembolic events at 1 year was significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months.

A similar study published in 2018 by the researchers from the University of Texas also warned about the increase in bleeding risks associated with the drug combination. The study also noted that the combination also lowered the risk of stroke when used together.

Sep 27, 2017: Plavix Verdict Affects Pelvic Mesh Cases

A move made this September wherein the plaintiffs involved in the pelvic mesh related injury against Boston Scientific agreed for their cases to be heard in a courtroom other than the Philadelphia Court of Common Pleas. This decision has its roots in the June 2017 "Bristol-Myers California Plavix" U.S. Supreme Court opinion, according to which the non-resident plaintiffs cannot continue their cases in state courts where they do not reside or the defendant companies are not corporate residents.

However, after giving it quite a thought and favoring a smooth functioning without any jurisdictional issue creating legal issues, the plaintiffs have agreed to this move. Our sources also inform us that the parties have agreed to litigate the cases in either Massachusetts, headquarters of Boston Scientific, or in Delaware, its state of incorporation. Boston Scientific has shown interest in resolving roughly 37,000 product liability cases filed against it with a few thousand already settled.

The June 2017 "Bristol-Myers California Plavix", has already been adopted by Bayer, headquartered in Pennsylvania, in removing a good number of cases from the Missouri federal court in the Essure litigation. It is expected that Bayer might press on the same ruling to dismiss hundreds of lawsuits in the other jurisdictions, like Philadelphia Court of Common Pleas, where Xarelto blood thinner cases are piling up.

Evidence:

  • Usage of Plavix in Pharmacy records
  • Duration of Plavix usage
  • Indication of Usage in Medical and Pharmacy Records
  • Complications and their treatment after intake

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.

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