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Vioxx, Celebrex and Aleve

Ills of a too-free market?

Philly.com - Dec. 23, 2004 - Major drugmakers are having a run of bad luck that could make for a sequel to the box-office hit Lemony Snicket's A Series of Unfortunate Events - but for the fact that this is no mock-Gothic story line, and that real-life patients' health is at risk. Merck & Co.'s arthritis pain medicine Vioxx is off the market after studies cited an increased risk of heart problems. Pfizer Inc. this week halted advertising for its popular pain-reliever Celebrex on the same grounds.

New warning labels are due for a companion Pfizer drug, Bextra, and even an over-the-counter alternative - naproxin, commonly known under the Bayer brand name Aleve - is under scrutiny. It's clear that these drugmakers failed to learn early enough all the dangerous side-effects from these supposed wonder drugs. In the case of Vioxx, officials at Merck had suspected it was risky for several years prior to the Sept. 30 recall. While their drugs helped millions of people cope with pain, the companies now must answer regulators' questions - and conduct their own internal reviews - as to how the danger of heath problems for some patients slipped notice for so long.

Each of these medications won federal regulatory approval. With drugs so heavily marketed with direct-to-consumer advertising, though, any second-guessing on safety by drugmakers may be deterred by the profitability of these products. Who wants to kill the golden goose, right? Well, if profit motives do come into play, the recent disclosures prove it's a case of pay now or pay later. The firms are facing a fearsome incentive to make sure their products are safe: from both Wall Street and the courts. Investors, for instance, punished Pfizer in recent days by driving down its stock price in heavy trading. That's how the system is supposed to work on behalf of stockholders, and it benefits consumers as well.

The other incentive for these firms is to avoid the likely huge legal costs stemming from lawsuits by patients who believe they were harmed by medications. Merck faces hundreds of such Vioxx claims already, with legal costs estimated to run into the billions. The potential for these legal claims to change corporate behavior is why it's so important to preserve citizens' access to the courts. That flies in the face of the constant drumbeat from the Bush administration and U.S. Chamber of Commerce about the need for Congress to rein in supposedly "frivolous" lawsuits. Access to the courts is all the more important with drug approvals - including some of the painkillers now under a cloud - subject to fast-track consideration by regulators.

Those regulators, meanwhile, are taking their deserved share of criticism. The troubling back story to the Vioxx, Celebrex and now Aleve announcements is that the U.S. Food and Drug Administration has provided inadequate scrutiny of drugs it approved as safe for consumers. That has to change, and improve. Consumers have more right than ever to demand better oversight. They cannot be reassured, though, by recent reviews of the FDA, including a broadside from the influential Journal of the American Medical Association. JAMA in late November faulted the agency's system of permitting drugmakers to self-report dangerous side-effects of approved drugs, describing it as "the fox in charge of the henhouse."

Without radical changes at the FDA, the JAMA editors contend, the United States will be "far short of having an effective, vigilant, and trustworthy" drug safety system. While the White House defends the FDA's performance, the agency has announced steps to improve safety reviews and heed more dissenting views from drug reviewers. Its first order of business should be to change a culture in which one in five of the FDA's scientists says they have felt pressured to approve new drugs despite qualms about safety, quality, or effectiveness.

It's encouraging to see bipartisan congressional support for a thorough review of the agency, as well as House and Senate scrutiny of drugmakers' actions in bringing these medications to market.

What medicine to take?

Staff reports
5/15/2005 - Figuring out what to take for pain relief, particularly for the aches and pains associated with chronic ailments like arthritis, has never been more confusing.

In September, the blockbuster pain relievers called COX-2 inhibitors — Vioxx, Bextra and Celebrex — began toppling off their pedestals. First, Merck announced that it was taking Vioxx off the market because a company study discovered a higher heart attack and stroke risk in users than in those on a placebo.

Then, in February, a Food and Drug Administration advisory committee concluded that all three drugs raised heart attack and stroke risk.

Finally, Pfizer took Bextra off the market in April at the FDA's request, leaving Celebrex as the only COX-2 inhibitor available in the USA. To top it off, the FDA announced that Celebrex and older prescription anti-inflammatory pain relievers, such as ibuprofen and naproxen, will have to carry a black-box warning — the strongest type of drug warning — about their heart attack and stroke risk. With each development, doctors received more calls from concerned patients about what to take for pain relief.

A new USA TODAY/ABC News/Stanford University Medical Center poll found that 1 in 4 American adults have taken at least one of the COX-2 inhibitors. (The poll of 1,204 adults has a margin of error of plus/minus 3 percentage points.)

In the poll, 14% of Celebrex users and 12% of the Vioxx or Bextra users said they have "personally experienced serious side effects" from the medications. The poll did not specify, but side effects of these drugs, as well as the older anti-inflammatory pain relievers, include fluid retention, swelling and indigestion. (The margin of error rises to 7 percentage points when looking at this group.)

The poll also found that 37% of those who took Vioxx/Bextra and 35% of those on Celebrex have found another medication that works as well, suggesting that many former users are still looking for an effective pain reliever.

Some of the major pain relievers now on the market in the U.S.
A few common examples (brand names in italics) Possible side effects/special notes

Non-Steroidal Anti-Inflammatory Drugs
• Ibuprofen: Motrin; Advil; Mobic
• Naproxen: Aleve
• Aspirin: Anacin; Bayer; Bufferin; Excedrin
• For all NSAIDs: Abdominal or stomach cramps, pain or discomfort; diarrhea; dizziness; drowsiness; edema (swelling of the feet)
• headache; heartburn or indigestion; nausea or vomiting
• Before taking these drugs, let your doctor know if you drink alcohol or use blood thinners or if you have had any of the following: sensitivity or allergy to aspirin or similar drugs, kidney or liver disease, heart disease, high blood pressure, asthma or stomach ulcers.
• Patients on long-term NSAIDs should have blood counts and liver enzymes checked periodically.

COX-2 inhibitor
Celebrex
• Same as for traditional NSAIDs.
• Unlike low-dose aspirin, there is no evidence that Celebrex protects against heart attack or stroke. Celebrex may be used with low-dose aspirin, but the combination may increase ulcer risk.
• Before taking Celebrex, tell your doctor if you have had a heart attack, stroke, angina, blood clot, hypertension or sensitivity to aspirin or other NSAIDs.
Narcotics
• Morphine: MS-Contin
• Methadone: Percocet
• Codeine: Vicodin
• Oxycodone: OxyContin
• Drowsiness, nausea and constipation.
• All of these drugs have the potential for abuse, so they are controlled substances under the jurisdiction of the U.S. Drug Enforcement Administration.
• A doctor's prescription is needed.

Other pain relievers
Acetaminophen: Datril; Tylenol
• Upset stomach.
• Call you doctor immediately if a skin rash occurs.
• Tell your doctor if you have ever had liver disease or a history of alcohol abuse.
• Should not drink alcohol while taking this drug.

Sources: www.arthirtis.org; The Pill Book, 11th edition; www.nhtsa.dot.gov; MedlinePlus; FDA GAO report 2004

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