• Posted September 20, 2024

FDA Says Drug Makers Will Stop Producing Fentanyl 'Lollipops'

Controversial fentanyl lollipops and similar products will no longer be made by drug makers, the U.S. Food and Drug Administration has announced.

Known as TIRF medications, these products contain fentanyl and are used to manage breakthrough pain in cancer patients who have become tolerant to around-the-clock opioid therapy, the FDA said in a statement released this week.

The decision by drug makers to stop selling such medicines follows decades of investigations and lawsuits against the drugmakers that had marketed the fast-acting painkillers too aggressively, CBS News reported.

In 2020, the FDA first tightened prescribing restrictions on the products, in response to data suggesting they were being given to patients who are not opioid-tolerant.

Drugmaker Cephalon had the FDA's approval to market these drugs for years under brand names like Actiq, a sweetened lozenge on a stick, or Fentora, a tablet that dissolves in the mouth.

Generic pharmaceutical manufacturer Teva Pharmaceuticals acquired Cephalon in 2011, when the market for Actiq was worth around $173 million a year, CBS News reported.

Teva officials did not respond Thursday to a request for comment on why it will stop selling the products, CBS News reported.

In 2022, Teva settled lawsuits from state and local governments that had accused the company of promoting Actiq and other powerful fentanyl painkillers for patients without cancer and downplaying addiction risks. 

Teva will stop selling the products on Sept. 30, the FDA said.

"FDA did not request this discontinuation. It is important to note that FDA does not manufacture medicine and cannot require a pharmaceutical company to make a medicine, make more of a medicine or change the distribution of a medicine," the agency added.

More information

The U.S. Drug Enforcement Administration has more on fentanyl.

SOURCE: U.S. Food and Drug Administration, news release, Sept. 16, 2024; CBS News