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.

Lab confirmed salmonella for Georgia peanut plant

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Posted on 29th January 2009 by Gordon Johnson in Uncategorized

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Date: 1/29/2009

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — A lab company president called to testify before Congress in the salmonella outbreak investigation said Thursday that manufacturers “can’t retest away a positive result.”

Charles Deibel, whose labs conducted tests for Peanut Corp. of America, said that if 100 containers were tested and only one or two turned up salmonella, the company should “throw the whole lot out.”

Federal health officials say Peanut Corp. shipped tainted peanut products from its Blakely, Ga., facility after retesting them and getting a negative result for salmonella.

Peanut butter, peanut paste and other goods from the plant are being blamed for an outbreak that has sickened more than 500 people, triggered a massive international recall and raised doubts about the food industry’s safety practices.

Deibel said his company — Deibel Labs Inc. — did not conduct day-to-day testing for the Blakely plant, but was asked on occasion to carry out certain tests. He said the company has turned over bacterial cultures to federal investigators.

Deibel and the president of another lab, J. Leek Associates Inc., have been called to testify Feb. 11 before the House Energy and Commerce Committee. The Deibel firm has been in existence since the 1960s and has its main lab in Chicago.

Rep. Henry Waxman, D-Calif., chairman of the panel conducting a hearing into the outbreak, said the investigation shows “major gaps” in the nation’s food safety system.

“I am extremely troubled by reports that the plant tested positive for salmonella numerous times but nothing was done to ensure that the product did not go on the market,” Waxman said.

Peanut Corp., based in Lynchburg, Va., said in a statement it “categorically denies any allegations that the company sought favorable results from any lab in order to ship its products.”

Deibel said his firm is still poring over records to determine what kind of testing was done, and at what times, for Peanut Corp.’s plant.

He said his lab tested some salmonella cultures that came from the J. Leek lab and identified the specific variety of the bacteria that was present. Those cultures have been turned over to investigators from the Food and Drug Administration and the Centers for Disease Control.

Darlene Cowart, president of the J. Leek lab, was not available Thursday.

Deibel his lab also tested samples of peanut products sent directly from the Blakely facility, but that he did not have the results of those tests available.

Salmonella can exist in a dormant state in products like peanut butter, isolated in pockets of a big batch. So experts say it’s possible to get positive and negative results from the same batch.

“The benefit of using multiple labs is you increase your chances of finding it,” said Deibel.

“Our recommendation to clients is that you can’t retest away a positive result,” he added. “We call it ‘testing into compliance,’ and that is frowned upon.”

Meanwhile, the Army joined the peanut recall Thursday. It’s removing some peanut butter items from warehouses in Europe.

In the civilian world, more than 430 kinds of cakes, cookies and other goods have been pulled off store shelves in what the FDA is calling one of the largest product recalls in memory. The Army’s recall does not affect Meals-Ready-to-Eat, but another kind of military grub called Unitized Group Rations-A, which provide a complete 50-person meal.

Nationwide, at least eight people may have died of illnesses linked to the outbreak.

The recall covers peanut butter, peanut paste, peanut meal and granulated products, as well as all peanuts — dry and oil roasted — shipped from the factory. FDA officials could not quantify the amount of products being recalled.

Officials recommend that consumers check the FDA web site, which lists all the products being recalled. Consumers who find any such products in their cupboards should toss them away. If they’re uncertain about eating a particular product, they should check it out first.

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On the Net:

FDA’s recall page: http://tinyurl.com/8srctw

Copyright 2009 The Associated Press.

FDA: Epilepsy drug may be risky for Asians

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Posted on 24th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/24/2008

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.

FDA questions Alpharma's abuse-proof pain pill

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Posted on 12th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/12/2008

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) _ Federal regulators questioned Wednesday whether Alpharma Inc. has provided enough evidence to show that its experimental morphine pill cannot be abused.

Alpharma has asked the Food and Drug Administration to approve Embeda as a tamperproof medication for patients with moderate to severe chronic pain. The pills are formulated so that the euphoric effects of morphine are blocked when a patient crushes, dissolves or chews them. Patients often abuse pain pills by grinding them up to snort or inject.

Friday, the FDA will ask a panel of outside advisers how effective Embeda is likely to be at discouraging such abuse.

Alpharma only studied the drug’s resistance to abuse when it was taken by mouth, but FDA reviewers noted that drug addicts often abuse pain pills by injecting them.

Embeda contains morphine along with an antagonist, a drug that neutralizes the effects of the narcotic when it is used inappropriately. However FDA reviewers questioned whether exposing patients to low levels of the antagonist might cause safety problems.

In its own studies, Alpharma said the most common side effects associated with the chemical were nausea and vomiting.

Cowen and Co. analyst Ian Sanderson wrote in a research note that the FDA’s review documents seemed favorable toward Embeda, and he expected a positive ruling from panelists on Friday. According to Sanderson, the agency is mainly looking to the panel for “advice on label language and risk management plan design.”

In its own briefing documents posted online, Alpharma said it planned to distribute pamphlets on the risks of morphine abuse to physicians who prescribe Embeda. The company also noted that the FDA has already demonstrated its commitment to approving similar medications that reduce the risk of abuse. Pills already on the market include Sanofi-Aventis SA’ Talwin NX and Reckitt Benckiser Pharmaceuticals’ Suboxone.

Bridgewater, N.J.-based Alpharma submitted Embeda to the FDA in late June. The agency agreed to give the application “priority review,” which takes six months, instead of the usual 10 months.

If Embeda is approved it would help offset lost sales of Alpharma’s morphine drug Kadian, which is expected to lose patent protection in 2010. The drug was Alpharma’s best-selling product last year with sales of $167.7 million.

Rival drugmaker King Pharmaceuticals Inc. is trying to buy Alpharma for $37 per share, or about $1.6 billion. Sanderson said that if Friday’s panel meeting goes poorly, King could drop that offer, which would sink shares of Alpharma. However, he said that outcome is unlikely unless the FDA panel “absolutely rejects” Alpharma’s application, which is not expected.

Shares of Alpharma rose $1.81, or 6.3 percent, Wednesday to close at $30.66.

Copyright 2008 The Associated Press.