Pharmaceutical companies are set to stop producing a controversial fentanyl-based painkiller by the end of the month, according to the Food and Drug Administration (FDA). The drugs in question, known as transmucosal immediate release fentanyl (TIRF) medications, include formulations like the “fentanyl lollipops” and tablets that dissolve in the mouth, which have been linked to the opioid overdose crisis.
These medications, such as Actiq and Fentora, were originally approved by the FDA for treating cancer patients who had developed a tolerance to other opioids. However, decades of investigations and lawsuits have revealed that drug companies were marketing these powerful painkillers beyond their approved use, encouraging doctors to prescribe them “off-label” to patients who did not meet the strict criteria, fueling widespread misuse and addiction.
The FDA noted that fewer than 150 patients are still receiving TIRF medications, and they can continue their treatment while supplies last. The discontinuation follows years of controversy, with drugmaker Cephalon, and later Teva Pharmaceuticals, which acquired Cephalon in 2011, facing legal challenges for promoting these drugs irresponsibly. Cephalon was found to have violated FDA regulations by promoting the painkillers to doctors for a broader patient base than initially approved, contributing to the opioid epidemic.
The decision to stop producing these drugs comes after the FDA tightened restrictions on their prescribing in 2020 due to ongoing concerns about their misuse. Research had shown that as many as half of the patients receiving the drugs were not opioid-tolerant, raising serious safety concerns. Additionally, in 2022, Teva settled lawsuits with state and local governments that accused the company of promoting Actiq and other painkillers for non-cancer patients and downplaying the risks of addiction.
While Teva has not provided a specific reason for discontinuing the drugs, the FDA has clarified that it did not request this move. The agency also emphasized that it does not have the authority to mandate the production of medications. Teva has advised healthcare providers to work with patients currently taking TIRF medications to transition to alternative treatments.