Discontinuation of Controversial Fentanyl Lollipops Announced by FDA

Discontinuation of Controversial Fentanyl Lollipops Announced by FDA

The Food and Drug Administration (FDA) announced that drugmakers will cease the sale of controversial fentanyl painkillers, known as “fentanyl lollipops,” by the end of the month. These medications, referred to as transmucosal immediate release fentanyl (TIRF), have been implicated in the opioid overdose epidemic due to aggressive marketing practices. Despite being approved for cancer patients tolerant to less potent opioids, investigations revealed off-label prescriptions were widespread, which contravened FDA guidelines.

Cephalon, later acquired by Teva Pharmaceuticals, marketed these drugs under brand names such as Actiq and Fentora. The decision to discontinue comes after numerous lawsuits and regulatory scrutiny over inappropriate prescription practices. While the FDA tightened prescribing rules in 2020, it remained concerned about the drugs reaching non-opioid-tolerant patients.

Currently, fewer than 150 patients continue to use TIRF medications, with existing supplies available for their treatment. The FDA clarified it did not request this discontinuation, nor does it have the authority to mandate production or distribution changes. Teva has not provided a comment on the decision. The company has previously settled lawsuits over its marketing practices for these painkillers.

Source: CBS News

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