Law Articles

Return to Law Dictionary Index

What was done about the inadequate Vioxx warnings?

by Michael Monheit, Esquire, Monheit Law, PC

For years leading up to its withdraw, the FDA had taken steps to force Merck and Pharmacia, the makers of these drugs, to disclose the risks associated with their products. Changes in medication labels have been made, along with orders to cease misleading advertising practices.

Doctors finally began to speak out and to inform their patients about the actual benefits, cost, and problems of Vioxx and Celebrex.

Class action suits were filed against Merck, the maker of Vioxx. The lawsuits are pending.

The warnings on Vioxx were late to come and the drug should have been pulled sooner.

Finally, on September 30, 2004, Merck got the message and pulled Vioxx from the shelves, and issued a Vioxx warning -- patients should stop taking the Vioxx and return the unused pills. The Vioxx warning came as a result of a study that showed the drug doubled the risk of heart attack and stroke. At the same time, it sounded an Vioxx warning alarm for the millions of people who took Vioxx.

The FDA should force companies like Merck to issue warnings on Vioxx sooner
The Food and Drug Administration needs to push drug companies harder to do long-term safety studies of drugs on the market once concerns develop so that a better Vioxx warning would have been developed before so many people were harmed.

Without the FDA pushing for these studies to develop better warning the public about the dangers of drugs like Vioxx, according to the University of Pennsylvania bioethicist Arthur Caplan the problem is like "we're relying on the fox to tell us about what's wrong inside the chicken coop."

On its own, Merck issued only a luke warm Vioxx warning.

In some cases, experts say, such warnings on Vioxx's official labeling aren't sufficient.

Since 2002, Merck's Vioxx warning mentioned increased cardiac risks based on results of its own post-approval study, but disputed its own findings and the drug remained on the market despite the Vioxx warning. Merck undertook the latest study because less-rigorous experiments indicated Vioxx could prevent recurrence of potentially cancerous colon polyps, said company spokesman Tony Plohoros.

Dr. Alastair Wood, professor of pharmacology and associate dean at Vanderbilt University School of Medicine, said it should not have taken so long for the heart risks to come to light. Had they come to light sooner, proper Vioxx warnings would have been issued.

People were hurt by the inadequate Vioxx warnings
"A helluva lot of people got the drug between 2000 and 2004, and a very quick, very cheap study would have determined that risk" had the FDA taken a tougher stance after the first sign of trouble, Wood said. If better studies were performed, Vioxx warnings would have been more stringent -- or the drug would not have been on the market at all.

About the Author

Michael Monheit, Esquire is the managing attorney for Monheit Law. The practice is focuses on plaintiff personal injury cases and Vioxx Lawyers info can be found at Vioxx Lawyer - Monheit Law

Return to Health Law

Return to Law Dictionary Index