Vioxx Drug Recall Information

Drugmaker Merck & Co. is pulling its best-selling arthritis drug Vioxx off the market, based on data indicating the drug increases the risk of heart attack and stroke among users.

Vioxx Summary

Vioxx is a non-steroidal, anti-inflammatory drug (NSAID), and is in a class of drugs commonly referred to as a "Cox-2 Inhibitors." It comes in liquid or pill form and is manufactured by Merck & Co. Vioxx is prescribed to relieve the symptoms of Osteoarthritis. It can also be used to treat acute pain in adults such as those patients who experience severe pain associated with menstruation. Vioxx works by blocking COX-2 enzymes in the body that trigger pain and inflammation.

Vioxx was approved by the US Food and Drug Administration in June of 1999. It has been widely prescribed since its introduction - over 52 million times. As this drug, along with the similar drug Celebrex, came onto the market it was touted by its manufacturer as, "effective at reducing arthritis pain, inflammation and stiffness… also effective for the relief of pain and inflammation of one of the most severe forms of arthritis, rheumatic arthritis." Doctors and patients thought that they may have a perfect drug to stop arthritic and other types of pain, without the stomach irritation that was otherwise associated with NSAIDs. However, recent reports linking Vioxx to serious health problems has caused great concern for the millions of Americans taking these drugs.

Drugmaker Merck & Co. is pulling its best-selling arthritis drug Vioxx off the market, based on data indicating the drug increases the risk of heart attack and stroke among users. The Whitehouse Station, N.J.-based pharmaceutical manufacturer said the immediate withdrawal of Vioxx was based on data from a three-year colon cancer clinical trial that showed a heightened risk of cardiovascular complications began 18 months after patients started taking Vioxx.

In addition to heart attacks and strokes, Vioxx has also been associated with several other life-threatening side effects, including blood clots, angina and nonbacterial meningitis, severe intestinal damage, ulcerations and bleeding, and kidney damage.

Many recent Vioxx lawsuits bring to light questions as to when Merck was first made aware that fatal side effects were associated with Vioxx, and whether the company failed to inform public health authorities of these side effects, in a timely manner. Additionally, Merck extensively marketed Vioxx as highly safe and effective, while minimizing its risks compared to other drugs on the market.

Additional Vioxx Recall Information

Prescription For Disaster
November 14, 2004, 60 Minutes - Did the manufacturer of Vioxx know that the painkiller could cause heart attacks and strokes long before it withdrew the drug from the market?

Add The Feds to Those Questioning Vioxx
November 9, 2004, Forbes.com, NEW YORK - Add the U.S. Justice Department and the Securities and Exchange Commission to the club circling Merck and Vioxx.  Yesterday, Merck, in an otherwise routine quarterly filing, revealed that federal investigators were investigating what Merck knew in advance of its recent withdrawal of its popular painkiller on the grounds that it boosted the risk of heart attacks in long-term users.

Wall Street Study Projects 50,000+ Lawsuits
Estimate assumes jury awards or settlements would require Merck to pay anywhere from $100,000 to $300,000 for each lawsuit, and that Merck might also pay another $1 billion to $2 billion in suits by Vioxx users who claim some other harm.

Merck falls as e-mails suggest Vioxx smoking gun
NEW YORK, Nov 1 (Reuters) - Merck & Co. Inc.'s <MRK.N> Vioxx recall is mushrooming into a product-liability nightmare that erased another $23 billion of the company's valuation on Monday, but analysts said it will likely withstand the crisis.  Merck may eventually pay $5 to $15 billion payout.

Merck Shares Plunge on Vioxx Denial News
November 1, 2004, Forbes.com, Shares of Merck & Co. plunged more than 7 percent Monday after a media report said that documents show the pharmaceutical giant hid or denied evidence for years that its blockbuster arthritis drug Vioxx cause heart problems.

Recall Rattles Patients ; Vioxx Heart Risk Should Vanish By Discontinuing Use of Drug, Physician Says.
October 19, 2004, RedNova.com, Some arthritis sufferers who appreciated the anti-inflammatory medicine Vioxx for its power over pain are now worried that the medicine might have hurt their heart.  Dr. Brent Mohr, a rheumatologist at the South Bend Clinic, said it will take a while for him and his staff to help patients make the transition to a different pain reliever.

Vioxx was long under research microscope
October 12, 2004, Newsday.com, The study's findings were dramatic: 20 patients on Vioxx had heart attacks. Only four had heart attacks on the comparison drug. But that's not the study that prompted Merck & Co. to yank Vioxx off the market two weeks ago.....

How did Vioxx debacle happen?
10/12/2004 USA Today -- Merck yanked Vioxx on Sept. 30 because a new study had found a higher rate of heart attacks and strokes in patients taking the drug than in those on a placebo...

Merck Braces For Wave of Vioxx Lawsuits
Sat, Oct. 02, 2004, Philadelphia Inquirer (Philly.com) -- "Our preliminary estimate is that about 16,632 people may ultimately file a legitimate lawsuit" against Merck over Vioxx, analyst Tim Anderson wrote in a report issued yesterday by the Prudential Equity Group...

Drug-Safety Reviewer Says F.D.A. Delayed Vioxx Study
In a series of testy e-mail exchanges with his bosses, a federal drug-safety reviewer contends that an effort to publish his study demonstrating the dangers of Vioxx was delayed and demeaned by top officials at the Food and Drug Administration. Click here to read more.

Internal FDA Memorandum Regarding COX-2 Selective and Non-Selective NSAIDS, including Vioxx.
Memorandum from David J. Graham, MD, MPH, Associate Director of Science, Office of Drug Safety to Paul Seligman, MD, MPH, Acting Director, Office of Drug Safety entitled, "Risk of Acute Myocardial Infarction and Sudden Cardiac Death in Patients Treated with COX-2 Selective and Non-Selective NSAIDS", 09/30/04

CNN: Arthritis drug Vioxx being pulled
NEW YORK (Reuters) -- The arthritis drug Vioxx, used by millions of people around the world, is being pulled off the market after a study confirmed long-standing concerns that it raises the risk of heart attack and stroke, the manufacturer, Merck & Co., said today.

Dow Average Falls After Merck Withdraws Vioxx; Nasdaq Advances
Sept. 30 (Bloomberg) -- The Dow Jones Industrial Average dropped after Merck & Co. retracted its third-quarter profit forecast because the company said it will no longer sell the Vioxx painkiller that generated $2.5 billion in sales last year.

Merck Vioxx Announcement: Merck Announces Voluntary Worldwide Withdrawal of VIOXX
Press Release for VIOXX Provided by Merck Pharmaceuticals (PDF Format)

ABC News: "A Disaster": Merck Recalls Arthritis Drug Vioxx
Merck Recalls Vioxx Because Data From Clinical Trial Finds Higher Risk of Heart Attack, Stroke

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