FDA announces drug manufacturers will halt production of fentanyl “lollipops”

FRIDAY, Sept. 20, 2024 (HealthDay News) — Controversial fentanyl lollipops and similar products will no longer be manufactured by drugmakers, the U.S. Food and Drug Administration has announced.

These products, known as TIRF drugs, contain fentanyl and are used to treat breakthrough pain in cancer patients who have developed tolerance to around-the-clock opioid therapy, the FDA said in a statement released this week.

The pharmaceutical companies' decision to stop selling such drugs followed decades of investigations and lawsuits against the manufacturers, who had marketed the fast-acting painkillers too aggressively, CBS News reported.

In 2020, the FDA tightened prescribing restrictions on the products for the first time in response to data suggesting they were being given to patients who do not have opioid tolerance.

For years, drugmaker Cephalon had FDA approval to market these drugs under brand names such as Actiq, a sweetened lozenge on a stick, or Fentora, a tablet that dissolves in the mouth.

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

CBS News reported that Teva officials did not respond to a request for comment on Thursday about the reasons for stopping sales of the products.

In 2022, Teva reached a settlement with state and local authorities that accused the company of promoting Actiq and other powerful fentanyl painkillers to non-cancer patients and downplaying addiction risks.

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

“The FDA has not required this discontinuance. It is important to note that the FDA does not manufacture drugs and cannot require a pharmaceutical company to manufacture a drug, manufacture more of it, or change the distribution of a drug,” the agency added.

More information

The US Drug Enforcement Administration has further information on fentanyl.

SOURCE: US Food and Drug Administration, press release, September 16, 2024; CBS News

What this means for you

Pharmaceutical companies will stop producing fentanyl lollipops and other similar products used to treat breakthrough pain in cancer patients who are already receiving opioid therapy.

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