FDA holds safety hearing on 50-year-old painkiller

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Posted on 30th January 2009 by Gordon Johnson in Uncategorized

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Date: 1/30/2009

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.

Gov't launches criminal probe in peanut recall

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Posted on 30th January 2009 by Gordon Johnson in Uncategorized

Date: 1/30/2009

By SHARON THEIMER and RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — The government has opened a criminal investigation into the Georgia peanut-processing plant at the center of the national salmonella outbreak, federal officials said Friday.

Stephen Sundlof, head of the Food and Drug Administration’s food safety center, said the Justice Department will join FDA investigators in looking into possible criminal violations. The Peanut Corp. of America plant shipped allegedly tainted products to dozens of other food companies.

“It is an open investigation at this time,” said Sundlof. “We can’t really talk much about the investigation itself.”

More than 500 people have been sickened as a result of the outbreak, and at least eight may have died because of salmonella infections. More than 430 products have been pulled off the shelves in a recall that reaches to Canada and Europe.

In another development Friday, officials urged consumers to be cautious about “boutique” brands of peanut butter, which had not previously figured in the recall.

Although national brands of peanut butter are unaffected, some smaller companies may have received peanuts from the processing plant in Blakely, Ga., the FDA said.

Meanwhile, the White House pledged stricter oversight of food safety.

Press secretary Robert Gibbs said Friday that President Barack Obama plans to name a new FDA commissioner and other oversight officials in coming days. Gibbs said they will establish a “stricter regulatory structure” to prevent breakdowns in food safety.

“I think the revelations have no doubt been alarming,” said Gibbs. That a company which found salmonella in its own testing would continue to ship products “is beyond disturbing for millions of parents,” he added.

FDA officials said they last inspected the Blakely facility in 2001, when it wasn’t being used to make peanut butter.

It did not get much attention from the federal government again until earlier this year, when a shipment of peanuts from the plant was returned from Canada because it was contaminated with metal fragments. The FDA then asked Georgia authorities to inspect.

But the state inspections did not detect what FDA officials say was a salmonella problem at the plant dating back to at least June of 2007.

The return of the contaminated shipment of peanuts was first reported by the Associated Press.

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Copyright 2009 The Associated Press.