Deaths Linked to Cephalon’s Cancer Pain Drug, Fentora

After receiving reports of deaths and other serious side effects, FDA is alerting consumers and health care professionals to concerns about the use of Fentora (fentanyl buccal) tablets, a potent opioid pain medication.

Fentora is used only for treating breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it—those who take a regular, daily, around-the-clock narcotic pain medicine. Breakthrough pain is intense increases in pain that occur rapidly, even when opioid pain-control medication is being used.

People who develop tolerance to narcotic pain medicines are more resistant to the dangerous side effects of these medications than those who take narcotic pain medication less frequently.

The deaths reported indicate that some cancer patients

  • should not have been prescribed this medicine
  • were prescribed the wrong Fentora dose
  • took too many Fentora doses
  • received Fentora as a substitute for another fentanyl-containing product that is not equal to Fentora

Important Safety Information

  • Ask your doctor if you are opioid-tolerant before taking Fentora. The drug should only be used for breakthrough pain in opioid-tolerant patients with cancer.
  • Fentora should not be used to treat any type of short-term pain, including headaches or migraines, pain after an operation, or pain due to injury.
  • People who only take narcotic pain medications occasionally should not use Fentora.
  • Do not substitute Fentora for other fentanyl medicines, including Actiq. The dosage strength of fentanyl in Fentora is NOT equal to the same dosage strength of fentanyl in other fentanyl-containing products. Using the same dose can result in a fatal overdose.
  • Read the Medication Guide that comes with Fentora,and follow the directions exactly.

Watch For These Signs

Get medical attention right away if you have any of these signs:

  • trouble breathing or shallow breathing
  • tiredness, extreme sleepiness, or sedation
  • inability to think, talk, or walk normally
  • feeling faint, dizzy, or confused

FDA Actions

  • requested the manufacturer, Cephalon Inc., strengthen warnings and improve the dosing instructions in the drug’s product labeling and Medication Guide for patients
  • requested the company improve their education plan for prescribers and pharmacists
  • published a Public Health Advisory and Health Care Professional Sheet warning health care professionals that it is critical to follow Fentora’s product labeling
  • monitoring the Fentora issue closely and reviewing available information, including adverse events
  • working with the manufacturer to ensure the safest use of the medicine
  • providing updates as new information is available

Adverse events related to Fentora should be reported to MedWatch, the FDA’s voluntary reporting program.

Source: FDA


  1. quiact says

    The Dangerously Euphoric Violet Delight

    Often, medications for pain are made from what are called opoid plants. These purple-flowered plants produce poppies that are used in the production to make the analgesic, opium.
    Poppy plants exist and are grown in areas of Asia. The country of Afghanistan is the number one producer of poppy plants. The United States is the number one country that consumes what is derived from these plants.
    Opium is what we in the U.S. call narcotics, and they essentially dull and numb those in pain who ingest these opium-based medications. The narcotics are the drugs of choice for pain management.
    Some narcotics are from natural opium, such as cocaine. In addition, the opiates from the poppy seeds can be used to create semi-synthetic narcotics, such as Heroin. Heroin was marketed by Bayer Pharmaceuticals for 12 years, and during that time this company told potential users of Heroin that it is a non-addicting form of morphine (pure opiate drug).
    This was believed to be a welcome relief for those many soldiers who became addicted to morphine after the U.S Civil War. During that same period of time, Bayer marketed heroin for other medical conditions, such as young children with coughs.
    Of course, we now know that Heroin is very addictive in fact. Ironically, Morphine has been given to Heroin addicts who are recovering.
    Opium-derived medicines once could be bought freely in the U.S. by anyone less than 100 years ago. Yet now, they are classified by the Drug Enforcement Agency as narcotics, and are scheduled accordingly to monitor and limit the use of such drugs by others, as there is a very real element of danger with narcotic usage by others.
    Internationally, the opium trade has been actively placed throughout the world. Historically, brutal force has been implemented by various nations to control what opium plants provide that others desire, as there is a pleasant euphoria experienced by the consumers of narcotics in addition to relieving pain.
    While prescribed to patients for such issues aside from pain on occasion, such as chronic coughing and diarrhea, the intended use of opium drugs is for pain management. Vicodin, which is comparatively a mild narcotic, is the most frequently prescribed and abused drug in the United States presently out of the narcotics available by prescription. Overall, there are about 10 opium-based medications available, and each has a length of effectiveness after administration for a period of about 4 hours
    If patients take opium-derived drugs for long periods of time, tolerance may develop with such patients. When this occurs, this patient needs and desires more of the opiate medication to acquire a level of relief. As a result, such patients may develop a dependence on these types of drugs, which is what often leads to addiction and possible abuse of the narcotic drug. This is why overdose of these types of drugs have occurred. The reasons for taking these drugs initially become replaced with a desperate need for relief due to addiction in some who take narcotics for a long period of time.
    Dan Abshear

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