By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — Call it the cold case file of drug safety.

Federal health officials convened a public hearing Friday on whether to ban Darvon, a painkiller first approved in 1957, when there were few alternatives for treating pain except aspirin and powerful narcotics.

Now mainly marketed as Darvocet, which includes a dose of acetaminophen, the drug remains one of the top 25 most commonly prescribed medications. More than 20 million prescriptions were written in 2007.

The consumer group Public Citizen said the FDA should withdraw Darvon from the market because the drug offers relatively weak pain relief and poses an overdose risk, with the potential to be used in suicides.

“It has unique risks and no unique advantages,” said Dr. Sidney Wolfe, a drug safety expert with Public Citizen who first sought a ban in the 1970s. “It has been a big drug of abuse for quite a long time.”

Two companies that market the drug — Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals— say the medication is safe and effective when used as directed. In documents filed with the FDA, the companies say doctors need a range of options to treat pain, and note that many other painkillers have become drugs of abuse.

Dr. Jerry Avorn, a professor of medicine at Harvard and a critic of the pharmaceutical industry, is glad the FDA is taking a hard look at Darvon.

“I have been astonished at how widely used this drug is,” Avorn said. “It’s no longer the most abusable and most dangerous drug in its class, but the fact that there are worse drugs doesn’t make Darvon a good drug.”

The United Kingdom banned its version of Darvon in 2005. The FDA, however, may take a more cautious approach, such as requiring stiffer warnings, safety studies or special education efforts aimed at doctors and patients.

The FDA awaited recommendations Friday from a panel of independent advisers.

In an analysis prepared for the hearing, the FDA’s safety office said it had searched the agency’s database of reported drug problems, but the result was “insufficient” to allow reviewers to make a clear-cut recommendation. The safety office found more than 3,000 reports of serious problems. The top three were suicide, drug dependence and overdoses.

In a separate analysis, the FDA office that handles painkillers said Darvon is a weak pain reliever. Most studies show that in Darvocet, the widely used combination drug, the Darvon component appears to contribute “little or no” additional pain relief beyond that provided by the acetaminophen component, reviewers said.

Wolfe presented the advisory panel with new data from the government’s Drug Abuse Warning Network, which tracks emergency room visits and deaths. It showed that Darvon-related deaths rose to 503 in 2007, from 446 in 2006. In both years, about 20 percent were suicides. The network covers only about one-third of the U.S. population.

Data from the Florida’s medical examiner reporting system showed that in 2007 Darvon was present in the bodies of 341 people who died from drug-related causes. Medical examiners identified it as the cause of death in 85 of the cases, or 25 percent.

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On the Net:

FDA meeting agenda: http://tinyurl.com/cg5k5a

Copyright 2009 The Associated Press.

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — The blockbuster asthma drug Advair does not appear to have an increased risk of serious complications seen with similar new medicines, federal health officials said Friday.

But a less widely used medication, Serevent, had a significantly higher rate of serious complications, and even deaths, the Food and Drug Administration said. Both medicines are made by the same company, GlaxoSmithKline.

The FDA is concerned about asthma drugs known as LABAs, long-acting medications that relax tight muscles around stressed airways and free patients from the need to take a puff from their inhaler every few hours. For many asthma sufferers, that means they can sleep through the night.

But LABAs, for reasons that are still being debated, can increase risks of death and complications in some patients. The risk is lower when a LABA is used together with a steroid to treat underlying inflammation deep inside the airways.

Advair combines both kinds of medicine in one inhaler. But Serevent is a LABA-only product, although medical treatment guidelines call for patients taking the medication to also use a steroid.

The FDA analyzed reams of clinical data on four drugs: Advair, Foradil, Serevent and Symbicort. All four already carry strong warnings, but the findings could lead to more specific instructions for patients and greater restrictions on some of the medications. The agency has called a special meeting of outside advisers next week to discuss the data and make recommendations.

GlaxoSmithKline said the analysis underscored its confidence in Advair, its best-selling medication, with U.S. sales of $2.9 billion in the first nine months of this year. But a spokeswoman declined to comment on whether the data could lead to a withdrawal of Serevent, which had U.S. sales of $97 million in the same period. About 4 million U.S. patients now use the Glaxo medications.

Asthma is a chronic respiratory illness that leaves patients short of breath, wheezing, and can sometimes send them to the emergency room because of difficulty breathing. Some 22 million people in the United States suffer from asthma, and children account for nearly one out of every three patients. Nearly 3,600 people still die from asthma in this country each year, although symptoms can be controlled with medication to prevent the most serious complications.

Copyright 2008 The Associated Press.

WASHINGTON (AP) _ Treatment with certain epilepsy drugs may expose some Asian patients to serious skin reactions, federal health officials warned Monday.

The Food and Drug Administration said it is investigating whether medications like Dilantin, Phenytek and Cerebyx, which are used to control epileptic seizures, can lead to severe skin blisters and bleeding for some Asian patients.

Patients who test positive for a gene known as HLA-B1502 appear to be at increased risk of developing the skin problems, preliminary data indicate. About 10 percent to 15 percent of patients from parts of China, Thailand, Malaysia, Indonesia and the Philippines may carry the gene, as do 2 percent to 4 percent of South Asians, including Indians.

The FDA urged doctors to monitor patients closely, but said there is not enough information yet to recommend genetic testing. In most cases, patients who develop the skin problems do so in the first few months after starting to take the medications.

Because of the problem with skin reactions, the FDA last year recommended genetic testing for Asian patients taking another epilepsy drug, carbamazepine, sold under several brand names including Tegretol and Carbatrol. Doctors should also avoid Dilantin and the other medications for patients who have already tested positive for the gene, the FDA said.

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On the Net:

FDA safety alert: http://tinyurl.com/5fcnlf

Copyright 2008 The Associated Press.