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The Drug That Was Vioxx

Vioxx Withdrawl and Drug Litigation

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Merck publicly announced the withdrawal of the drug from the market worldwide on September 30, 2004.

In addition to its own studies, on September 23, 2004 Merck apparently received information about new research by the FDA that supported previous findings of increased risk of heart attack among rofecoxib users (Grassley, 2004). FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 percent of which were probably fatal, in the five years the drug was on the market.

On November 5 the medical journal The Lancet published a meta-analysis of the available studies on the safety of rofecoxib (Jüni et al., 2004). The authors concluded that, owing to the known cardiovascular risk, rofecoxib should have been withdrawn several years earlier. The Lancet published an editorial which condemned both Merck and the FDA for the continued availability of rofecoxib from 2000 until the recall. Merck responded by issuing a rebuttal of the Jüni et al. meta-analysis (Merck & Co., 2004).

In 2005, advisory panels in both the U.S. and Canada encouraged the return of Vioxx to the market, stating that Vioxx's benefits outweighed the risks to patients.

VIOXX Lawsuits

Vioxx is a prescription medication that has been used primarily in the treatment of signs and symptoms of arthritis, but has also been prescribed to treat acute pain in adults and menstrual pain in women. It is a Cox-2 selective nonsteroidal anti-inflammatory drug or NSAID. Other Cox -2 selective NSAIDs on the market are Celebrex and Bextra. Vioxx is also related to nonselective NSAIDs such as ibuprofen and naproxen.

In September of 2004, its manufacturer, Merck & Co, voluntarily recalled Vioxx worldwide, due to safety concerns. The FDA issued a public advisory regarding the safety of Vioxx, though it was pulled from the market before the FDA had an opportunity to do a thorough review.

During a clinical trial in which Vioxx was being studied for its effectiveness for preventing the recurrence of colon polyps and as well as its long term safety, the study had to be halted because of the observed risk of increased cardiovascular risk after 18 months of continuous treatment with 25mg of Vioxx as opposed to those receiving a placebo (sugar pill). Merck pulled the drug from the market when the study confirmed longstanding concerns about the drug and demonstrated that the regular use of Vioxx doubled the patient’s risk of heart attack or stroke if used regularly and for a prolonged period.

The FDA originally approved Vioxx in May 1999. At that time, their data, which included approximately 5,000 patients, did not indicate an increased risk for heart attack and strokes. However, later studies such as the one involving colon polyps, and another to study the effects of Vioxx upon stomach ulcers, show a correlation between the regular use of Vioxx and increased risk for heart attack or stroke.

After the recall of Vioxx, many doctors have recommended patients switch to other Cox-2 inhibitors such as Celebrex or Bextra, however, these medications have raised health concerns as well. Other patients have been advised to treat their symptoms with NSAIDs such as ibuprofen or naproxen.

Vioxx Help Center The Vioxx MDL # is 1657: Section L. Correspondence with Judge Eldon E. Fallon may be sent to the following address:

Honorable Eldon E. Fallon
United States District Court,
Eastern District of Louisiana
500 Poydras Street, Room C-456
New Orleans, LA 70130
Tel:(504) 589-7545
Fax: (504) 589-6966
Web Site: Vioxx Product Liability

Wayne Walker is president of CapTran, the leader in litigation financial services. http://www.captran.com

© 2005 Capital Transaction Group Inc

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