Heart Attack or Stroke Risk Found with Use of Plavix and Heartburn Drugs

According to new research, combining Plavix and heart burn drugs known as proton-pump inhibitors, which include Nexium and Prilosec, could substantially increase the risk of heart attack and stroke. This presents a particular problem for many patients, since the drugs are often prescribed together to combat the risk of gastrointestinal bleeding associated with Plavix side effects.

Plavix (clopidogrel) is an anti-blood clotting agent prescribed to decrease the risk of stroke and heart attack, and it appears that Nexium, Prilosec and other heartburn drugs may prevent the drug from working.

On Wednesday, Medco Health Solutions, Inc. and researchers from the Indiana School of Medicine presented new findings at the annual scientific meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).

The study reviewed data for 16,690 individuals who were taking Plavix after receiving a stent to prop open previously clogged arteries. After comparing data over a 12 month period from 2005 to 2006, researchers found that those who were using Plavix together with a proton-pump inhibitor (PPI) faced a 51% increased risk of heart attack and stroke side effects when compared to those who were taking Plavix alone.

Proton-pump inhibitors are a class of medications that are prescribed to reduce gastric acid production, and prevent severe bleeding problems that could be caused by Plavix. The most commonly known drugs included in this class are Nexium (esomeprazole), Prilosec (omeprazole), Protonix (pantoprazole) and Prevacid (lansoprazole).

Researchers found that the individual risk of heart attack and stroke associated with each of these drugs when used together with Plavix ranged from 39% to 61%.

Several recent studies have also addressed the concerns about the effects of combining Plavix and heart burn drugs, leading the FDA to issue an early communication in January 2009 to notify healthcare providers that they are reviewing the safety of Plavix .

The FDA indicated that it could take several months for them to complete their evaluation of the risk, and recommended that doctors reevaluate the need for patients treated with Plavix to use PPI drugs. The drug regulatory agency also indicated that other drugs that can be used to reduce stomach acid, such as H2 blockers like Zantac, Pepcid, Tagamet and Axid, or antacids doe not appear to interfere with the antiplatelet activity of Plavix.

The manufacturers of Plavix, Bristol-Myers and Sanofi Aventis, currently face a number of lawsuits which have been filed by users of the blood thinner who allege that the manufacturers failed to warn about potential side effects which could increase the risk of heart attacks, strokes, ulcers, gastrointestinal bleeding and an uncommon blood disorder known as thrombotic thrombocytopenic purpora (TTP).

At least 27 Plavix lawsuits pending in the U.S. District Court for the District of New Jersey were reinstated last month after being on hold for over a year pending the outcome of a Supreme Court decision issued in March 2009, which supported the plaintiffs’ claims.

Plavix lawyers who have been holding off on filing new lawsuits while the litigation was on hold, are now preparing to move forward with potentially thousands of cases.