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FDA Panel Rejects Expanded Use of Fentora | cialis online

FDA Panel Rejects Expanded Use of Fentora

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A Food & Drug Adminstration (FDA) advisory panel rejected Cephalon Inc.’s proposal to expand uses of the narcotic painkiller Fentora, over fears that the highly-addictive drug will be misused, leading to overdose deaths. Fentora contains fentanyl, an opiate that is 80 times more potent than morphine. Cephalon has reported five patient deaths due to negative reaction or overdose of the drug. In September 2007, the FDA issued a public health advisory, warning that several Fentora-related deaths had occurred in patients who were prescribed the drug for off-label use. The FDA advisory warned that Fentora should not be used for any other conditions including migraines, post operative pain or pain due to injury.

Despite the overdose dangers, Cephalon has continued to push the FDA to expand Fentora’s approved uses. At yesterday’s advisory panel meeting, however, FDA scientists testified that widening approval of Fentora could have dangerous effects because of the risks for improper prescribing and abuse of the drug, which is more potent than other pain medications.

While Fentora is only approved for cancer patients, it is known that as many 80 percent of people using it do so “off-label” to headaches and back pain. Once a drug has been approved by the FDA doctors are free to prescribe it as they see fit, but drug companies are legally barred from promoting off-label use. Cephalon has been the subject of several investigations into off-label promotion of Fentora and other narcotic painkillers. In November, the company reached an agreement with the US Department of Justice to pay $425 to settle charges stemming from the illegal marketing of Fentora, as well as another of its narcotic painkiller, Actiq.

Cephalon tried to ease fears over Fentora misuse by proposing a plan that would require pharmacists to electronically confirm a patient’s symptoms before dispensing the drug. While some panelists like that idea, they want Cephalon to perform more studies to prove its plan will help reduce medication errors and abuse of the drug. Several panel members also said Cephalon should conduct more studies to determine if Fentora offers more benefits to non-cancer patients than other painkillers already approved for such conditions.

Patients suffering from ailments like back pain and migraines already have access to many approved narcotics, causing many panelists to question the need for expanded Fentora approval. “How many people are we going to help with the release of this product and how many are we going to hurt?” asked panel member Dr. Charles Cortinovis, of the Veterans Administration Hospital in Pittsburgh. “In my mind it is very scary to release such a large amount of powerful opiate into the American population.”

In the end, the advisory panel voted 17-3 against recommending that approved uses of Fentora be expanded. The FDA is expected to make its final decision on Fentora by mid-September. Though the agency is not bound by the recommendations of advisory panels, it usually follows them.

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