Potent pain patches used to treat breakthrough pain in cancer patients already on around-the-clock pain medication are being recalled by the manufacturer because the patches may release too much of the painkiller Fentanyl which can lead to serious adverse events including death.
Potent pain patches used to treat breakthrough pain in cancer patients already on around-the-clock pain medication are being recalled by the manufacturer because the patches may release too much of the painkiller Fentanyl which can lead to serious adverse events including death.
Cephalon, maker of the potent pain killer Fentora, has filed a citizen petition to the Food and Drug Administration (FDA) claiming that Watson Pharmaceutical's copycat version of Fentora differs chemically from Fentora and thus should have to go through a lengthier approval process reserved for new drugs rather than the shorter process reserved for generic drugs. This is Cephalon's latest attempt to block generic competition for Fentora, which had sales of $87 million during the first six months of 2010.
Fifty-six patients from one health care clinic have died and 96 others were sent to the emergency room with overdoses after taking a powerful painkiller for a use not approved by the Food and Drug Administration (FDA). The drug in question is Cephalon's Actiq, a opioid approved by the FDA to treat breakthrough pain in cancer patients already being treated around-the-clock with opioids.
The Food and Drug Administration (FDA) has approved a new version of the painkiller OxyContin that is designed to be harder to abuse. OxyContin is a potent prescription narcotic pain reliever that slowly releases opioid oxycodone in patients who require around-the-clock medical management to treat moderate to severe pain. OxyContin is part of a class of painkillers known as opioids that includes morphine, Actiq and Fentora. Like all opioid narcotics, OxyContin can produce a sense of euphoria and thus puts patients at greater risk of addiction and dependence on the drug.
When the Food and Drug Administration (FDA) approved the new opioid medication, Onsolis, last summer, it did so with care. The potent fentanyl delivered through the mouth's mucous membranes by way of a lozenge on a stick similar to a lollipop, is only approved to treat breakthrough pain in cancer patients 18 and older already receiving around-the-clock opioid treatment.
In 2007, drug maker Cephalon sent a letter to pain management specialists reminding them that its potent painkiller Fentora should only be used to manage breakthrough pain in cancer patients who are already taking and are known to be tolerant to opioids, painkillers in the same class as morphine. Cephalon informed these health care professionals that some patients had died while using Fentora and some serious adverse events occurred because of what the company called "improper patient selection (e.g. use in opioid non-tolerant patients), improper dosing, and/or improper product substitution." Reports revealed that two deaths occurred in patients given Fentora to treat headaches. A third person died because he took the wrong dose, and a fourth patient took the drug to commit suicide.
Ed McAteer relies on the powerful opioid Actiq to help him "survive as a human being." He suffers from painful migraines so severe he says that a whiff of fresh-cut grass can cause him extreme headaches. His doctor prescribed him Actiq, a fentanyl citrate that comes in a lollipop lozenge. It is only approved by the Food and Drug Administration (FDA) for the treatment of breakthrough pain in cancer patients already on around-the-clock opiods. But McAteer's doctor, a renowned pain specialist at Beth Israel Medical Center in New York, felt the application would be both safe and effective for his patient.
Fentora is a powerful painkiller in the opioid family, similar to morphine, and is approved by the Food and Drug Administration (FDA) for the very limited use for the treatment of breakthrough pain in cancer patients currently on around-the-clock opioid therapy. The active ingredient in Fentora is fentanyl buccal. Fentora comes in the form of a lozenge on a stick, like a lollipop. The lozenge is placed above the rear molar tooth between the upper cheek and gum. Patients sometimes experience a gentle bubbling sensation where the tablet was placed as it dissolves.
Meet Mark. He is a 40-year-old father of three, former college basketball player, and an opioid addict. In February, Mark began a week-long effort to end his addiction before his wife came home from a trip. He says she is the source of his drug abuse. Not intentionally, but her occasional offerings of the powerful painkillers such as Actiq and Fentora to curb his constant headaches drove him to depend on the drugs. Coming clean, he says, has been emotionally and physically painful. He talks about his withdrawal symptoms and urges others to use caution with the drugs in a series of videos he calls the Actiq Diaries designed to show "the evils of the drug called Actiq."
