Drug Maker Agrees to Pull Painkiller From the Market

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July 14, 2005 www.latimes.com

Drug Maker Agrees to Pull Painkiller From the Market

The FDA says Palladone could be fatal when taken with alcohol. No

deaths are reported.

By Gellene, Times Staff Writer

Connecticut drug maker Purdue Pharma agreed to withdraw a powerful

new painkiller from the market because it could be fatal when taken

with alcohol, the Food and Drug Administration said Wednesday.

Palladone, a once-daily capsule, is similar to OxyContin, a widely

abused painkiller also made by Purdue.

The drug has a time-release mechanism that is intended to make it

less susceptible to abuse than OxyContin, a tablet that could be

crushed to provide a powerful high.

Alcohol, however, defeats the time-release function, potentially

accelerating the effect of the drug to a fatal level, the FDA said.

The agency said it knew of no fatalities associated with Palladone.

About 11,500 patients have received the medicine since it reached the

market in February, Purdue said.

Purdue conducted two tests on the interaction of alcohol and the

drug. The first experiment, which took place before the painkiller

was approved in September, involved placing the capsule in a beaker

of alcohol.

Although the test suggested that alcohol could enhance the drug's

effect, the FDA was focused on " street use " of the drug and missed

the potentially grave significance of the test for patients, said

Meyer, director of the FDA office that regulates painkillers.

" The study was done to see if there was any way if people who wish to

abuse the drug could get it all out, " Meyer said. " We did not

appreciate the risk to patients…. It's a lesson learned for us. "

The second test, conducted after the capsule was cleared for sale by

the FDA, used volunteers who consumed the painkiller and alcohol.

Purdue spokesman Heins said the company conducted the second

test in healthy volunteers to assess " abuse liability. "

Volunteers were given varying doses of alcohol and the medication. To

ensure their safety, volunteers were also given a drug that blocked

the effect of hydromorphone, the narcotic in Palladone.

It was this second test — which confirmed in the human body results

of the earlier test — that raised concerns at the FDA. Purdue

suggested adding a warning to Palladone's label, Meyer said. But

after performing its own chemical tests and reviewing Purdue's

results, the agency Tuesday asked the company to withdraw the drug.

The FDA was concerned that patients might forget about the warning

and consume a lethal amount of alcohol.

" We went through a rigorous discussion internally to make sure all

considerations were properly weighed, " Meyer said. " We take the

treatment of pain seriously and consider it a public health problem. "

Meyer said the fact that alternative painkillers were available also

factored into the FDA's decision.

Heins said Purdue hoped to reformulate the drug and one day return it

to the market.

The withdrawal is bad news for Purdue, a closely held company based

in Stamford, Conn. OxyContin, which had sales of $1.3 billion in

2004, now faces generic competition and declining sales. Last month

the company announced a plan to cut 1,000 jobs.