The Food and Drug Administration (FDA) voted to allow Trilipix, a cholesterol lowering medication, to continue to be marketed as a drug that can prevent heart attacks. The approval comes despite government studies showing that there were no substantial changes in incidences of heart attacks in patients taking Trilipix in conjunction with other cholesterol lowering medications.
In addition to allowing Abbott to continue marketing Trilipix as reducing the risk of heart attacks despite evidence to the contrary, the FDA also voted against measures that would have forced the drug manufacturer to change the drug’s label to include disclaimers of the drug’s effectivenss.
The only stipulation the FDA imposed on Abbott was that it must conduct its own study on Trilipix’s effects on reducing heart attacks. Experts have suggested that this study could cost Abbott over $100 million to conduct. While this might seem like a large sum of money, it pales in comparison to the $1.6 billion that Abbott Laboratories made last year off sales of Trilipix and TriCor, another cholesterol lowering drug.
Both Trilipix and TriCor are classified as fibrates, a type of drug that has been thought to help to reduce cholesterol. According to Abbott’s marketing of Trilipix and TriCor, both drugs can help reduce the risk of heart attacks when taken in conjunction with statins. Statins are drugs that lower cholesterol by blocking the production of HMG-CoA reductase, an enzyme that helps produce cholesterol.
The government-run study had investigated the incidences of heart attacks among patients taking Trilipix in combination with statins, such as Lipitor and Zocor. Of the 5,000 participants, just as many of those taking a statin alone had heart attacks as those taking both Trilipix and a statin. This study calls into question Abbott’s claims that adding Trilipix to statin therapy programs brings added benefits to patients. Basically, the government study shows that there is zero benefit to taking Trilipix if the patient is already taking a statin-type drug. Yet the FDA is continuing to allow Abbott to make these claims.
While FDA approval is obviously essential in order for prescription drugs to stay in the marketplace, a recent Supreme Court ruling in Wyeth v. Levine held that prescription drugs can be held liable for harm caused even if the drug meets the standard set by the FDA. So while FDA approval is important, it no longer exempts a company from liability. Therefore, pharmaceutical companies need to make sure their drugs are living up to their claims; otherwise, consumers might have a cause of action in court.
Kreisman Law Offices has been handling Illinois pharmaceutical lawsuits for over 35 years, serving individuals and families in and around Chicago, Cook County, and surrounding areas, including Inverness, Skokie, Darien, and Calumet City.
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