Merck Vioxx News and Press Releases

December 26, 2004 - Arthritis patients have been under intense pressure lately and it has more to do with heart problems associated with a variety of painkillers as opposed to arthritis itself, and it all started with the recall of Vioxx. For example, the US Food and Drug Administration says Pfizer's Celebrex and Bextra, both Cox-2 inhibitors, should be reserved for patients at high risk of gastrointestinal bleeding. The agency issued the advisory after Celebrex was shown to increase the risk of heart attacks and strokes by more than three times during a high dose cancer trial.

Vioxx, also a Cox-2 inhibitor, was withdrawn from the market by Merck in September when a study showed it increased the risk of heart attacks and strokes by two times, compared with a placebo.

Aleve, with the active ingredient Naproxen, available over-the-counter in the US, was also associated with increased heart risks recently. The FDA advisory also include a warning to patients taking this non-steroidal anti-inflammatory drug. The FDA said consumers taking Aleve should strictly follow label instructions and not exceed recommended doses. The FDA also warned people not to take the drug for more than 10 days, unless instructed to do so by a physician.

The entire issue over drug safety emerged earlier this year when Vioxx, one of the most effective arthritis medications was associated with major cardiovascular events. For the past three months arthritis patients have seen their drug options dwindle to a point where some people suffering from arthritis have refused to take any medication for their pain.

Arthritis patients and doctors have difficult choices to make. The FDA is advising doctors to weigh the benefits against risks when prescribing Cox-2 inhibitors for their patients. However, many people suffering with arthritis have lost faith in the system.

It may have started with Vioxx, but many people are asking,"Where will it end"?

FDA Panel Mulls Vioxx Risk

By Melissa Davis
Senior Writer

2/16/2005 - Medical experts spent Wednesday trying to digest both the risks and rewards of blockbuster painkillers already swallowed by millions of patients across the country. As a three-day hearing kicked off, the Food and Drug Administration began weighing testimony about the safety of drugs that it approved for widespread use more than five years ago. The so-called superaspirins once promised safe pain relief without stomach problems but have since been linked to heart problems.

Merck (MRK:NYSE) voluntarily withdrew one of the drugs, Vioxx, last year following a study that exposed significant cardiac risks after extended use. But this week's session could help decide whether the entire class of drugs, known as Cox-2 inhibitors, should carry harsher warnings or perhaps even follow Vioxx off of pharmacy shelves.

Ned Braunstein, senior director of Merck Research Laboratories, said that recent data "strongly suggest" that the class as a whole may be posing risks. "Long-term comparative studies are needed," he said. "More work needs to be done."

Originally, Merck adopted a different stand when pulling Vioxx from the market. The company said that it chose to withdraw Vioxx because patients could choose alternative treatments with no proven links to heart problems. Merck's biggest rival, Pfizer (PFE:NYSE - commentary - research), manufactures two Cox-2 inhibitors -- Bextra and Celebrex -- that remain on the market. Similar drugs, including one by Merck, still await FDA approval.

One physician complained Wednesday about Merck's shift in attitude. He noted that the company had always portrayed Vioxx as the sole drug in its class clearly labeled to reduce stomach problems. Thus, he questioned why the company suddenly decided that alternatives existed when Vioxx presented heart problems. "It sounds like you're trying to have your cake and eat it, too," he declared. Shares of Merck fell 1.5% to $28.91 Wednesday afternoon. Pfizer slid 1.7% to $27.48.

Vioxx, Bextra, Accutane, Crestor, Meridia, Serevent and Now Celebrex and Even the OTC Medication Aleve… Are the Drugs We Take Really Safe?

New York, NY (PRWEB) January 6, 2005 -- The headline of the New York Times on November 14, 2004 perhaps said it best. "Despite Warnings, Drug Giant Took Long Path to Vioxx Recall." The article describes Merck"s decision in May of 2000 to directly test "a disturbing possibility that Vioxx, a painkiller, might pose a heart risk." The study was rejected by executives at the company.

With the blockbuster drug Vioxx being pulled from the market, and now, with several other widely-written prescription drugs such as Celebrex coming under closer scrutiny by the government, combined with the potential problems with OTC drugs such as Aleve---drug safety has become –and rightly so—a major focus for all of us.

Scott Hendler of Hendler Law in Austin, Texas and New York, New York (www.Hendlerlaw.com) practices pharmaceutical litigation and closely monitors the pharmaceutical and over-the-counter drug industries. And now with what may become the largest investigations of drug company and FDA testing methods in US history, Hendler passes along what he tells his friends, his own family members and his clients.

What can you do to insure drug safety for you and your family regarding drugs such as Vioxx, Bextra, Celebrex and Aleve? Scott Hendler is available for interviews. Please call Amy Krakow 212 699 9024.

For more than a decade, Hendler Law, an international plaintiff's trial firm, has devoted its practice to helping people who have been victimized by corporate misconduct, specializing in toxic injury and pharmaceutical drug litigation. With offices in Austin, TX and New York, NY, the firm provides professional legal representation and offers a range of support services to clients and their families as they seek accountability for their injuries and cope with their illnesses. For more information, please visit www.HendlerLaw.com.

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