FDA OVERLOOKS DANGERS OF OFF-LABEL FENTANYL
- August 28, 2018
When you hear the word fentanyl, your mind probably jumps straight to overdoses or contaminated cocaine. However, there is a class of fentanyl drugs that has a legitimate medical use for something called breakthrough pain – sudden, sharp bursts of pain that occur despite an existing around the clock pain regimen. Quick-absorbing fentanyl sprays, tablets, and lozenges called T.I.R.F.s (transmucosal immediate-release fentanyl) contain a narcotic up to 50 times stronger than heroin and up to 100 times stronger than morphine. These medications include Actiq and Fentora, made by Cephalon, and Subsys, made by Insys Therapeutics. Unfortunately, despite the fact that they were approved only for cancer patients with high opioid tolerance, doctors have been prescribing them for other conditions, like back pain and migraines, putting patients at risk. People taking these medications must stick to their around the clock regimen, otherwise their tolerance will decrease and they’ll be in danger of accidental overdose, respiratory depression, and death.
The Food and Drug Administration did create an oversight program in 2011, meant to reduce the number of off-label prescriptions, but enforcement was left to a group of pharmaceutical companies that make and sell the drugs. Some of the companies have been sued for illegally recommending other uses for the medications, and in one case even bribing doctors to prescribe higher doses. Needless to say, the program wasn’t terribly effective.
Now, researchers at the Johns Hopkins Bloomberg School of Public Health have obtained 5,000 pages of information – via the Freedom of Information Act – showing that the FDA was aware of the breadth of off-label prescribing but did little to stop it. Officials at the FDA responded that because the information they were receiving was from a variety of sources, such as prescriber surveys, insurance claims, and industry reports, it was too difficult to measure the actual harm to patients.
One of the FDA documents was a survey by the industry group from 2013. In it, nearly 40 percent of T.I.R.F. prescribers said they had recommended the drug to treat chronic pain in patients who did not have cancer.
In an article in the New York Times, one woman described her experience with the TIRF drugs. She made an appointment to see a doctor about pain from fibromyalgia and back injuries sustained in car accidents. When she met with the doctor, she was surprised to find another person sitting in on her appointment – a sales representative from Insys, the maker of the under-the-tongue narcotic spray Subsys. She was not told that the medication was for terminal cancer patients. A little over a year later, she was found dead with the amount of fentanyl in her blood between 15 and 20 times the proper level.
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