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Cephalon’s Fentora lozenge, for acute cancer pain, could be headed for further labeling revisions and changes in its risk management approach, amid reports of four deaths associated with the product.
In light of the deaths, which occurred this summer, Cephalon and US regulators are re-evaluating the existing risk management program for Fentora as well as labelling, company spokesperson Stacey Beckhardt said. “We are looking at all aspects of the Fentora program,” she said, adding that, “Labeling revisions are on the table.”
Of the four deaths, one involved a suicide by a person who took Fentora without a prescription. The other three were given Fentora not in accordance with its label.
The listed Pennsylvania-based company has sent details about the deaths to physicians and other prescribers, and the US Food and Drug Administration issued a safety alert on its website 13 September. Shares of the company tumbled on news of the deaths, from a high that day of USD 76.92 to USD 71.98.
The FDA MedWatch site wrote that Fentora should be used in patients who already have developed a tolerance for narcotic painkillers, known as opioids, by taking them around-the-clock. Two of the deaths involved patients who were not taking opioids around the clock, but instead were being treated for migraines, Beckhardt said.
Current labelling for Fentora states that the product is not indicated for acute pain. But as a result of the deaths, Beckhardt said, the labelling will now clarify that the type of acute pain for which Fentora is not intended to include headache and sports injury.
In the other two deaths, one case was the result of inappropriate dosing and the other was a suicide. All three deaths are still under investigation and no information from autopsy reports has been made available, Beckhardt said. “We do not know the actual cause of death.” Media reports of respiratory failure as the cause of death were erroneous, though respiratory failure is a serious concern with opioid use, she said.
These deaths come as Cephalon is facing tough scrutiny in a congressional probe of alleged improper marketing of Fentora and Actiq, a narcotic painkiller in lollipop form.
In addition to the three deaths, there also were a small number of other adverse events recently linked to Fentora, Beckhardt said, declining to elaborate. Further, she said, the company has determined from phone records of consumer questions that there have been instances of “prescribing that we perceived as medication errors.”
The Fentora safety alert that Cephalon is circulating to the health care community states that the company’s other cancer pain drug, Actiq, should not be used as a substitute for Fentora.
Actiq cannot be substituted for Fentora on microgram-to-microgram basis, Beckhardt said, because Fentora is more readily absorbed in the body than Actiq. With Fentora, 65% of the drug gets absorbed in the bloodstream and gut, while 47% of Actiq gets absorbed this way, she said.
Dr Narinder Duggal, a clinical pharmacy specialist and medical director of Liberty Bay Internal Medicine in Washington state, said doctors are not well educated by the industry or by academics on how to switch patients to a new opioid, particularly those used for chronic use. “We have very poor data in terms of correlation of how much is a bioequivalent dose of one [opioid] drug to the other.” He urged industry and academics “to do that work for us, so that we have a good scale between the various medications available that can guide doctors... [A]lot of times it’s really hit or miss, which is unfortunate.”
Priscilla Merrill, a registered nurse at the University of Virginia’s cancer clinic, said her facility does not use Fentora or Actiq due to potential safety issues. “We are not currently using Fentora and given the current warning and limitations, we are not likely to do it soon. We will continue with our standard breakthrough regimens.” She also said the facility does not use Purdue Pharma’s OxyContin, which has been so widely abused in her region that area pharmacies do not carry it.
Both Fentora and Actiq are short-acting fentanyl products used to relieve pain associated with breakthrough cancer pain, a flare-up in the usual course of chronic cancer pain. Fentora currently is being studied in non-cancer patients with breakthrough pain.
It contains the narcotic fentanyl and belongs to a class of drugs known as opioids that carry a “black box,” the strongest warning issued by the US Food and Drug Administration. As with other narcotic painkillers, Fentora also is monitored by the US Drug Enforcement Administration, due to its potential for abuse or misuse.
All such opioids have risk management procedures that are supposed to help guide prescribing practices. Asked if the risk management program was effective, Beckhardt said, “I think we have taken strong action here and will continue to take action to ensure appropriate dosing and administration of this medication.”
Cephalon has a market cap of USD 4.89bn.
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