FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product

September 30, 2004 | In The News

FDA News – The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications. Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps. (more…)

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Popular Arthritis Medication Proven to be Dangerous. Law Suit Filed in Brazoria County Against Two Pharmaceutical Companies.

September 16, 2002 | Press Release, Randy Howry

A message was sent to pharmaceutical giants Merck and Co. and Pfizer Pharmacia Corporation from the Brazoria County Courthouse where a lawsuit was filed on behalf of an otherwise healthy Pennsylvania woman who had been taking the popular arthritis medications Vioxx and Celebrex and unexpectedly suffered a fatal heart attack. Also listed in the lawsuit as a defendant, along with Merck and Pfizer Pharmacia, is one of the leading medical research facilities that tested Vioxx on humans – R/D Clinical Research, Inc. in Angleton, Texas.

The medications Celebrex and Vioxx are very similar in that they are both classified as Cox-2 inhibitors, which fight inflammation without causing ulcers that older drugs, like ibuprofen, might. Both drugs saturated the market beginning in 1999 and have been multibillion-dollar blockbusters ever since. More than 100 million prescriptions were written for Vioxx and Celebrex in a one-year period ending July 12, 2000. That same year, in 2000, concerning data was published in the New England Journal of Medicine regarding potential serious cardiac side effects caused by taking Celebrex and Vioxx. In 2001, the FDA mandated that Merck include warnings on the drug label as it became apparent that Vioxx had caused unexpected cardiovascular events among people who had no serious cardiac risk factors. Only recently were warning labels added to the medication labels.

“If you consider how many people have taken Vioxx in good faith from the time it became available on the market to the time they finally included the warning labels, the number is in the hundreds of millions. There are many known people like our client whose lives have been forever altered or ended because they had a devastating heart attack or stroke without any medical history of cardiac risk factors,” explains Randy Howry, lawyer and partner of Herman, Howry, Breen, LLP, the Austin-based law firm that filed the lawsuit.

Because of the integral role of R/D Clinical Research maintained in the drug testing of Vioxx, it was decided that the lawsuit would most appropriately be filed in the city of their headquarters, Angleton, Texas, and the county seat of Brazoria County.

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