3 deaths prompt drug-firm warning

WASHINGTON - Shares of drug-maker Cephalon fell sharply yesterday, following warnings from the company that three people died from improper use of a powerful painkiller intended for cancer patients.

Cephalon, based in Fraser, Chester County, Pa. , told doctors in letters sent Monday that the fatalities were caused by errors in prescribing the drug, Fentora, to non-cancer patients - two of whom were being treated for headaches.

The letters were posted online yesterday by the Food and Drug Administration, which approved Fentora last year to treat intense bursts of pain experienced by cancer patients already taking more conventional painkillers.

Cephalon is one of several drug companies under investigation by Congress for allegedly promoting its drugs for uses not approved by the FDA. Doctors are allowed to prescribe medications for any use they deem appropriate, though companies are only allowed to market products for uses approved by the government.

A company representative said the deaths were not linked to allegations that Cephalon improperly promoted the drug for so-called off-label use.

Earlier this year, the House Oversight Committee ordered Cephalon to turn over all promotional materials for Fentora, as well as an earlier version of the drug, Actiq. The Connecticut Attorney General's office is conducting a similar investigation of the company.

The company said yesterday it is working with FDA on a new drug label to clarify when and how it should be used.

"We believe it's very important to clarify the information already on the label to make sure medical community is using the medication as safely as possible," spokesman Stacey Beckhardt said.

In its letters to physicians, Cephalon warned them not to prescribe the medication for types of pain it is not approved to treat. The letter also stresses that patients never take more than two pills per pain episode and should wait at least four hours before treating another pain episode.

Thomas Weisel Partners analyst Donald Ellis said prescribing errors are common with new drugs and that the news probably won't hurt sales of Fentora.

However, Ellis said the safety concerns could make it tougher for Cephalon to win approval for additional uses for Fentora.

Cephalon plans to ask FDA to approve the drug to treat severe pain that is unrelated to cancer in the fourth quarter.

Shares of Cephalon fell $3.99, or 5.21 percent, yesterday to $72.55 in afternoon trading. *