Painkillers: November 2006 Archives

HealthDay News -- Aspirin is often recommended by cardiologists for its blood-thinning properties, but the medication can lead to complications, including stomach problems.

The Cleveland Clinic says you should always check with your doctor before starting a daily aspirin regimen.

In general, the clinic says, people at risk for the following conditions may benefit from aspirin therapy:

• Heart attack
• Blood clots or stroke caused by blood clots
• Unstable angina
• Transient ischemic attacks (TIAs) or "mini-strokes

source - Healthday

Pfizer Inc. may fall short in convincing federal regulators that its painkiller Celebrex should receive expanded approval to treat children with a devastating form of arthritis, according to documents released Tuesday.

Pfizer wants Food and Drug Administration approval to sell Celebrex as a treatment for juvenile rheumatoid arthritis, or JRA, which affects as many as 60,000 U.S. children. The disease causes painful joint swelling and can affect growth and development.

However, an FDA review of the New York company's application questions whether the drug works for the pediatric disease. The FDA approved the drug for use in adults with osteoarthritis and rheumatoid arthritis in 1998.

With flu-shot season in full swing and widespread anticipation of the HPV vaccine to prevent cervical cancer, a new University of Rochester study suggests that using common painkillers around the time of vaccination might not be a good idea.

Researchers showed that certain nonsteroidal anti-inflammatory drugs (NSAIDs), also known as cyclooxygenase inhibitors, react with the immune system in such a way that might reduce the effectiveness of vaccines.

The research has widespread implications: study authors report that an estimated 50 to 70 percent of Americans use NSAIDs for relief from pain and inflammation, even though NSAIDs blunt the body's natural response to infection and may prolong it.

People starting treatment with methadone have died and suffered life-threatening side effects, health officials said Monday in warning of the dangers of overdosing on the painkiller.

Overdoses of the increasingly popular narcotic can cause slow or shallow breathing and dangerous changes in heart beat that patients might not feel, the Food and Drug Administration said.

Those side effects, including reports of deaths, have been seen in patients starting methadone treatment for severe pain or who switched to the drug after using other strong narcotic pain relievers, the FDA said in a public health advisory.

The FDA warned that methadone only provides pain relief for four to eight hours, but can linger in the body for eight to 59 hours. That can lead patients to take more of the drug before it has been eliminated by the body, causing the drug to build up in the body to toxic levels, the FDA said.

WASHINGTON -- Despite Celebrex's well-documented link to higher heart risks, Pfizer Inc. wants permission to sell its painkiller to treat children as young as 2 who have arthritis.

Even as critics call for the drug to be removed from the market, Food and Drug Administration advisers will meet Wednesday to consider the company's request to expand Celebrex use.

Celebrex was the first of a class of new-style painkillers, called cox-2 inhibitors , approved in December 1998, and it is the last one to remain on the market. The drugs were designed to relieve pain without causing the stomach distress associated with other treatments, but they have been plagued by safety concerns. Merck & Co. pulled Vioxx from the market in 2004 after its studies showed the painkiller doubled the risk of heart attacks and strokes. Merck now faces more than 20,000 Vioxx lawsuits. Pfizer, under pressure from the FDA, last year halted sales of another cox-2 inhibitor, Bextra , because of heart risks and potentially fatal skin reactions.

NEW YORK (AFP) - A US federal judge refused to allow a class-action lawsuit to proceed against Merck for health problems linked to its Vioxx pain medication, in a major victory for the pharmaceutical giant.

Judge Eldon Fallon, asked by an interstate judicial panel to consider how to handle the thousands of lawsuits filed over Vioxx, said the cases did not meet the criteria for a national class action suit, where one court would hear the case for all plaintiffs.

"While the majority of plaintiffs in this case allegedly suffered either a heart attack or stroke as a result of ingesting Vioxx, the extent of each plaintiffs subsequent injuries varies widely," he said in a 25-page decision.

OTTAWA - Forget heroin. Legal prescription drugs readily available in pharmacies are now the major source of illicit opioid drug abuse in several major Canadian cities, which raises questions about drug control in the country, a new study released today reveals. This tendency was also mentioned in U.S. prescription drug crackdown leads to heroin use.

Although heroin addiction has been one of the most significant drug problems in Canada for years, research shows users are turning to opioids, or prescription painkillers such as Oxycontin, Percocet and morphine, at an increasing rate.

"The intensity of the shift surprised me quite a bit,'' said Dr. Benedikt Fischer, study author and addictions researcher at the Centre for Addictions Research of British Columbia. "This study, for the first time, shows that systematically, and I would not have assumed, this is such a dramatic shift.''

WASHINGTON -- Researchers looking at the safety of various arthritis and headache remedies said on Thursday they had found some more evidence that the popular analgesic naproxen may cause heart problems.

The researchers themselves cautioned about reading too much into their findings, and outside experts discounted them.

Nonetheless, the researchers said they thought it was important to present their evidence to help experts sort out what the real dangers are.

WASHINGTON (Reuters) - A crackdown on illegal use of prescription narcotics like the powerful painkiller OxyContin has caused some addicts to switch to heroin, a Justice Department report said on Wednesday.

The report by the department's National Drug Intelligence Center identified the main drug threats in the United States for the coming year.

"In some areas, such substitutions among prescription drug abusers have been widespread, creating new challenges for local law enforcement and public health agencies compelled to address a widening local heroin user population," it said.

PARIS  -- Saliva from humans has yielded a natural painkiller up to six times more powerful than morphine, Paris researchers say.

The substance, dubbed opiorphin, may spawn a new generation of natural painkillers that relieves pain as well as morphine but without the addictive and psychological side-effects of the traditional drug.

One gram of opiorphin injected into rats' paws for every 2.2 pounds of body weight achieved the same painkilling effect as 3 grams of morphine, NewScientist News Service reports.

Celebrex - the only Vioxx-like drug still on drugstore shelves - could soon be sold specifically as a treatment for rheumatoid arthritis in children if the Food and Drug Administration approves a Pfizer request to do so.

The FDA has already approved Celebrex (celecoxib) to fight pain and inflammation but not specifically for use in children. Only 20 percent to 30 percent of FDA-approved drugs are specifically labeled for pediatric use.

But now Manhattan-based Pfizer is seeking FDA approval to market Celebrex specifically in children 2 years and older who have rheumatoid arthritis.

CHICAGO - The first published studies of Arcoxia, the drug that Merck & Co. hopes will take the place of its withdrawn painkiller Vioxx, are getting mixed reviews from doctors, some of whom say the results do not make a case for the medication's approval.

The critics cite not just Arcoxia's side effects but also that Merck tested it against diclofenac, an older painkiller known to raise heart risks. A fairer comparison would have been to a medicine that does not do that, such as naproxen, sold as Aleve, they say.

"The development program for Arcoxia is fatally flawed," said Dr. Steven Nissen, a Cleveland Clinic cardiologist who formerly headed the Food and Drug Administration's cardiac drug advisory panel. "My advice to the FDA is that they should not approve this drug."

NEW YORK -- Merck & Co. agreed to drop some of its objections to plaintiff lawyers' request for fees in a Vioxx case, but only if it doesn't have to disclose its own legal fees to a judge.

Plaintiff lawyer Ellen Relkin said Merck dropped some of its objections because it fears a N.J. judge may publicly disclose what it spent on a trial that ended earlier this year. Merck lawyer Ted Mayer said the drugmaker's legal fees have no relation to the plaintiff lawyers' request and that companies always want to be careful when asked to reveal such sensitive information.

Any disclosure of what Merck spent on a case would provide a window into how much the drugmaker's strategy of individually trying each of the roughly 24,000 cases it faces will ultimately cost. So far, Merck has set aside about $1.57 billion to cover legal expenses.

The FDA today announced a recall of about 11 million bottles of store-brand acetaminophen 500-milligram caplets.

Those caplets are over-the-counter drugs for pain relief and fever reduction. They're sold by about 130 companies, including Wal-Mart, CVS, and other drug stores, grocery stores, and wholesalers.

The recall is due to "small metal fragments found in a small number of these caplets," states an FDA news release.

The fragments range in size from "microdots" to 8-millimeter pieces of wire, according to the FDA.

The FDA and the caplets' maker, Perrigo Company of Allegan, Mich., are investigating how those metal fragments got into the caplets.

So far, no illnesses, injuries, or consumer complaints have been reported to the FDA or Perrigo, according to the FDA.

NEW YORK (CNNMoney.com) -- Novartis plans to bring a new arthritis painkiller to the U.S. market, but analysts say its similarity to the disgraced drug Vioxx could kill its chances of becoming a billion-dollar blockbuster.

The Swiss drug giant Novartis AG (up $0.32 to $61.55) said Tuesday that its painkiller Prexige was given a green light in the European Union for the treatment of arthritis. Novartis plans to "resubmit" the drug to the Food and Drug Administration in 2007, following the agency's request for more information in 2003.

Compared to Vioxx from Merck & Co., Inc., (up $0.33 to $46.14, Charts) Prexige has a better profile with regard to heart attack and stroke risks. Nonetheless, the drug is a member of the Cox-2 inhibitor class of drugs -- the same as Vioxx -- and could have a hard time winning the approval of American doctors and patients, not to mention the FDA.

"Doctors will be afraid to use this drug and ultimately that's what limits its potential," said Gbola Amusa, analyst for Sanford C. Bernstein. "Even when it's approved, doctors will see a safety issue with the drug and not use it as much."