Vioxx might be put back on the shelves in Canada

Forbes is reporting (via AP) that a Canadian panel is recommending Vioxx be put back on the market:

An expert panel is recommending that Health Canada allow the controversial painkiller Vioxx back onto the market.

By a 12-1 vote, panel members concluded the benefits of Vioxx in providing pain relief outweigh the increased risk of heart attack and stroke. Merck & Co. withdrew the drug from the worldwide market last September after a study showed it doubled patients risk of heart attacks and strokes.

Earlier this year, a panel of outside experts narrowly voted to recommend to the U.S. Food and Drug Administration to allow Vioxx back on the market.

Merck spokesman Guy Bizzoco said the company hadn’t decided whether to reintroduce Vioxx in Canada and looked forward to discussing the issue with local officials. He added there are continued discussions with U.S. regulators about Vioxx’s future.

The Canadian panel unanimously recommended that Celebrex continue to be sold but gave thumbs down to returning a third drug in the same class, Bextra, to the market. Celebrex and Bextra are made by Pfizer Inc.

“It’s now up to Health Canada to decide if it will accept the recommendations,” the article said.

Medical whistleblowers speak out against FDA

EurekaAlert has published a very interesting article about medical whistleblowers speaking out…

The US Food and Drug Administration (FDA) was “the single greatest obstacle to doing anything effective” about Vioxx, said FDA drug safety officer David Graham at an unprecedented roundtable of medical whistleblowers sponsored by the Public Library of Science (PLoS) and the Government Accountability Project.

In comments that echoed his now infamous testimony to the US Senate Finance Committee, Graham said that, “Nearly 60,000 people probably died from that drug. That’s as many of our soldiers that were killed in the Vietnam war [who] died as a result of Vioxx use. And FDA had the opportunity, the responsibility, to stop that and didn’t.”

Graham was one of five high profile medical whistleblowers invited by the medical investigative journalist Jeanne Lenzer to meet together in Washington DC on May 15th 2005 to share their accounts of practices in medicine and medical research that they believe are risking the public’s health or safety. Lenzer’s account of the roundtable, in which she outlines the lessons we can learn from these whistleblowers, is published in the open access international medical journal PLoS Medicine. One of the lessons, says Lenzer, is that “ties between drug regulators and industry may influence new drug approval.” Graham said at the roundtable that the FDA was in “a collaborative relationship” with industry, and that the FDA gets money from drug companies through the Prescription Drug User Fee Act “to approve new drugs and approve them more quickly.” A senior official at the FDA, said Graham, had told him, “industry is our client.”

“The pharma-FDA complex has to be dismantled,” he said, “and the American people have to insist on that, otherwise we’re going to have disasters like Vioxx that happen in the future.”

If the FDA had been more objective, could many of today’s class action suits have been avoided? Hm…

Viagra: a class action future?

The FDA is looking into blindness as possible side effect of Viagra, the AP reported today.

WASHINGTON -— Federal health officials are examining rare reports of blindness among some men using the impotence drugs Viagra and Cialis, a disclosure that comes at a time when the drug industry can ill afford negative publicity about another class of blockbuster medicines.

The Food and Drug Administration still is investigating, but has no evidence yet that the drug is to blame, said spokeswoman Susan Cruzan.

This type of blindness is called NAION, or non-arteritic anterior ischemic optic neuropathy. It can occur in men who are diabetic or have heart disease, the same conditions that can cause impotence and thus lead to Viagra use.

The FDA has 42 reports of the blindness, 38 among users of Viagra and four among users of Cialis. There were no cases reported among users of Levitra, the third impotence drug.

“Analyst Jason Napodano of Zacks Investment Research Inc. said he doesn’t think Viagra sales will stumble because of the new reports because the number of cases is so small.”

Doctors and patients have become increasingly wary of the downsides of prescription drugs after Merck & Co. yanked its pain reliever Vioxx from the market last year because of its potentially lethal side effects.

Merck potentially faces thousands of lawsuits over Vioxx and analysts have estimated its liability may reach $18 billion.

Pfizer was asked to remove its pain reliever Bextra from the market because of its side effects and sales of its other arthritis drug Celebrex are falling. Vioxx, Celebrex and Bextra all fall into a category of drugs known as Cox-2 inhibitors.

Industry critics have been demanding that drug companies conduct more post-marketing studies in order to do a better job of discovering side effects once drugs hit the market.

For more than two decades, Americans have mostly pressed for quicker approval of what they hope can be lifesaving drugs for such diseases as AIDS and cancer. But many now are wondering if medicines — a $200 billion industry annually — are coming out too fast and doing too much harm.

Viagra also is at the center of controversy over Medicaid’s payment for prescriptions of the drug to convicted sex offenders in New York and other states.

Viagra is made by Pfizer and was approved by the FDA in 1998.

FDA’s MedWatch

If you’re at all concerned about Vioxx, Bextra, Celebrex, Accutane, or Zyprexa, you may want to bookmark the FDA’s MedWatch page, which is “your Internet gateway for timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration.”

MedWatch is “The FDA Safety Information and Adverse Event Reporting Program,” and it contains a wealth of information and updates on adverse reactions to various medications, devices, and so forth.

For instance, today the front page includes recently updated info on counterfeit drugs coming from Mexico, external defibrillators, and meds like Zometa, Aredia and Natrecor.

Find Legal Help

Findlaw not only helps the public find attorneys, it also provides news on legal cases, helps students interested in legal professions, and provides businesses with resources to get started and operate. An extensive listing of topics under “For the Public” includes Baycol, Serzone, Bextra, Prempro, Vioxx, Celebrex, mesothelioma, asbestos, as general medical malpractice. A search on “class action lawsuits” returns 1050 entries, and the Class Action and Mass Tort Center contains its own search engine to narrow your quest for information on a particular subject. Special sections list recall and safety information about consumer products, drugs and medical devices, and food safety and inspection. The website has numerous newsletters you can sign up to receive from general legal news to specific courts (federal and some states) and issues (environmental, constitutional, immigration).

Older NSAIDs (Motrin, Advil, Aleve) as risky as Vioxx and Bextra?

Timesleader.com (out of Northeastern PA) runs an interesting Q & A column authored by pharmacist Richard Harkness. Recently, Richard was asked about Bextra and Vioxx:

Bextra has followed Vioxx in being pulled off the market because of increased risk of heart attack and stroke. Now I hear that the older types of these drugs (NSAIDs) have been found to carry this same risk. I thought this was a problem only with the newer drugs. Can you explain?

Here’s what he had to say:

It seems we’ve been blindsided once again by this latest news on NSAID-type drugs. Vioxx, Bextra and Celebrex are newer NSAIDs called COX-2 inhibitors. They and traditional NSAIDs such as Motrin (ibuprofen) are mainstays for pain and arthritis symptoms.

Reading news releases during the past months has been like watching an infection spread. First to get the cardiovascular risk bug was Vioxx. Next, Celebrex came down with it, then Bextra. Finally, the traditional NSAID naproxen appeared to catch it, causing suspicions to spread through the entire lot.

So far, only Vioxx and Bextra have been yanked from the market, leaving Celebrex as the only COX-2 inhibitor left standing, though on shaky ground itself. Bextra also had been linked to a serious skin reaction called Stevens-Johnson syndrome.

Besides the new “black box” warning on prescription versions of NSAIDs, each prescription fill will include a special pamphlet that outlines the warnings in consumer friendly language.

Additionally, the FDA will require stronger warnings on labels of OTC NSAIDs relating to dose and duration of use, as well as additional information about cardiovascular and stomach risks. These include ibuprofen (Advil), naproxen (Aleve) and ketoprofen (Orudis KT).

Now to your question: How might traditional NSAIDs increase cardiovascular risk?

First, the evidence implicating traditional NSAIDs is weaker than that for COX-2 inhibitors. In a prior column I hinted at a possible answer. That column sought to explain how COX-2 inhibitors could increase cardiovascular risk based on their effects on blood platelets, cells that enable blood to clot.

In short, COX-2 inhibitors could favor blood clot formation and thus might promote heart attack or stroke. In contrast, traditional NSAIDs would seem to have a neutral effect on platelets and clotting.

So what might explain their link to cardiovascular risk?

Here’s the hint I mentioned: Both traditional NSAIDs and COX-2 inhibitors tend to cause fluid retention (edema) and increased blood pressure. For this reason, a long-running recommendation has been to use NSAIDs cautiously in individuals with high blood pressure or congestive heart failure. This might be how traditional NSAIDs affect cardiovascular risk. It could also be that these drugs are not strictly neutral on blood clot formation.

But all this is guided speculation. Right now we just don’t know for sure how NSAIDs boost these risks.

Celebrex gaining Bextra’s prescriptions

BusinessWeek is reporting that the “Pfizer Inc. arthritis drug Celebrex has been the biggest beneficiary of last month’s withdrawal of Bextra, a pain reliever made by the same company. Celebrex has grabbed roughly a third of Bextra’s prescriptions while Mobic, a pain reliever marketed by Boehringer Ingelheim GmbH and Abbott Laboratories Inc., has captured around 26 percent.”

Analysts said the shift to Celebrex is a glimmer of good news for Pfizer, but they note the glory days of the drug are firmly behind it, as doctors have increasingly shifted patients to other prescription medications or over-the-counter products.

And here are some more details:

For the week ended May 6, Celebrex picked up 34 percent of Bextra’s prescriptions, according to Verispan, which tracks prescription data. A week earlier, it grabbed 32 percent. For the week ended May 6, Celebrex’s new prescriptions totaled 228,898, while new prescription reached 92,674 — its best showing in at least three months.

What medicine to take?

USA Today ran an interesting article about medicines recently:

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.

Here are some stats from a USA TODAY/ABC News/Stanford University Medical Center poll:

• 1 in 4 American adults have taken at least one of the COX-2 inhibitors
• 14% of Celebrex users and 12% of the Vioxx or Bextra users said they have “personally experienced serious side effects” from the medications.
• 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.

Bextra Back on the Shelves?

Pfizer still thinks that Bextra could be beneficial to certain patients and will be meeting with the FDA to find out how they can get their product back on the market:

Pfizer predicts a return of Bextra
Drug maker plans meeting with FDA about conditions under which it might be sold.

Reuters

Pfizer on Tuesday said it will meet with the Food and Drug Administration over withdrawn arthritis drug Bextra after its chief executive expressed confidence about the drug’s eventual return to the market.

Pfizer, the world’s largest drug maker, said it believes Bextra could be an important treatment option for certain patient populations. It said it plans to discuss with the FDA the options under which Bextra could be made available to such patients.

Earlier Tuesday, Pfizer CEO Hank McKinnell told Reuters it was “fairly likely” the drug would return to the market.

Pfizer suspended sales of Bextra in April after U.S. and European regulators said the risk of serious side effects from the drug outweighed its benefits.

Bextra is part of a class of drugs known as COX-2 inhibitors that also includes Pfizer’s drug Celebrex and Merck & Co Inc’s Vioxx, which was withdrawn last year due to increased risks of strokes and heart attacks.

The Food and Drug Administration has said Bextra provides no added advantage as a painkiller and can cause a potentially life-threatening skin condition called Stevens-Johnson syndrome, an allergic reaction that usually begins as a blistering of the mouth and lips and can spread to the rest of the body.

Pain Relievers’ Safety Questioned (Motrin, Advil?)

The AP is reporting that doctors are now questioning the safety of drugs such as Motrin and Advil:

THE ISSUE: The removal of Vioxx and Bextra from the market because of heart risks has led to worries that other pain relief medications carry similar danger.

WHAT: A study on preventing oral cancer in smokers in Norway examined their use of a variety of painkillers.

RESULTS: Those taking daily doses of non-steroidal anti-inflammatory drugs, or NSAIDs, had double the risk of dying of heart-related problems.

WHICH DRUGS: Nonprescription NSAIDS include ibuprofen (brand names include Motrin, Advil and Medipren), naproxen (Aleve) and ketoprofen (Orudis, Actron). No additional risk was seen from aspirin or from Tylenol, which is not an NSAID.

Raed more here

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