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.