Teva to halt fentanyl lollipop sales by September 30

The FDA announced that Teva Pharmaceuticals will cease sales of fentanyl lollipops and other transmucosal immediate release fentanyl (TIRF) medications by September 30. This decision follows decades of scrutiny and legal challenges against drugmakers for their role in the opioid crisis, particularly regarding the aggressive marketing of these potent painkillers. Currently, fewer than 150 patients are using TIRF medications, and they may continue treatment until supplies run out. Teva acquired Cephalon in 2011, which had previously marketed these drugs under brand names like Actiq and Fentora for cancer patients tolerant to less potent opioids. However, investigations revealed that Cephalon's sales practices often violated FDA regulations, leading to widespread off-label prescriptions. In 2020, the FDA tightened prescribing restrictions due to concerns that many patients receiving these medications were not opioid tolerant. In 2022, Teva settled lawsuits from various state and local governments that accused the company of promoting these drugs for inappropriate uses while downplaying addiction risks. The FDA had previously faced criticism for not adequately addressing the inappropriate prescribing of TIRF medications, with reports indicating that up to half of the patients using them were ineligible. As the discontinuation approaches, Teva and other manufacturers have advised healthcare providers to transition patients to non-TIRF treatments. The FDA clarified that it did not request this discontinuation, emphasizing that it does not have the authority to mandate pharmaceutical companies' production or distribution decisions.