Health Highlights: Sept. 26, 2007

Mar. 23 -- Here are some of the latest health and medical news developments,compiled by editors of HealthDay:

FDA Warns About Cancer Pain Drug Fentora

Due to recent reports of deaths and other problems associated with the cancer pain drug Fentora (fentanyl buccal) tablets, the U.S. Food and Drug Administration on Wednesday issued a warning about the drug to doctors and patients.

Fentora is a powerful opioid pain drug used only for the treatment of breakthrough pain in cancer patients who no longer respond to standard opioid pain treatment, the FDA said. Breakthrough pain refers to intense increases in pain that occur with rapid onset, even when opioid pain control drugs are being used.

The reported deaths of patients receiving Fentora were the result of improper selection of patients, dosing or improper product substitution, according to the Public Health Advisory and Health Care Professional Sheet issued by the FDA.

The agency reminded doctors and other health professionals that it is critical to follow product labeling when administering Fentora, and that it's dangerous to use Fentora for any short-term pain such as headaches or migraines. Fentora must not be used in patients who are not opioid tolerant.

Patients must be under a doctor's care and close supervision when taking Fentora and the dose should be carefully adjusted to control breakthrough pain adequately, the FDA said.

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The agency told Fentora manufacturer Cephalon Inc. to strengthen warnings and improve the dosing instructions on the drug's product labeling. The company must also improve its education plan for prescribers and pharmacists on proper patient selection, dosing instructions, and restrictions on substituting Fentora for other products.

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