Drugmakers to stop making controversial fentanyl lollipops, FDA says
Drugmakers have decided to stop selling a kind of controversial fentanyl painkiller at the end of this month, the Food and Drug Administration said this week, marking an end to a controversial brand of “fentanyl lollipops” and other formulations blamed for playing a part in fueling the opioid overdose epidemic.
The end of sales of the drugs, which doctors call transmucosal immediate release fentanyl or TIRF medications, follows decades of investigations and lawsuits against the drugmakers that had aggressively marketed the fast-acting and powerful painkillers.
“As of the date of this announcement, there are fewer than 150 patients receiving treatment with TIRF medicines,” the FDA said in a statement published this week. Patients who are currently on a one of these medicine may continue treatment while the supply is available, according to the statement.
Drugmaker Cephalon had the FDA’s approval to market these drugs, old under brand names like Actiq, as a sweetened lozenge on a stick, or Fentora, a tablet that was designed to dissolve in the mouth, for treating cancer patients who had developed a tolerance to less powerful opioids.
But investigators found the company’s salespeople were flouting FDA rules curbing marketing of the painkillers, getting doctors to more widely prescribe the addictive drugs “off-label” outside the narrow scope of the agency’s approval.
Generic pharmaceutical manufacturer Teva Pharmaceuticals moved to acquire Cephalon in 2011, at a time when the market for Actiq was worth around $173 million a year.
It is unclear why Teva has moved to stop selling the drugs. A spokesperson for Teva did not respond to a request for comment.
The FDA moved in 2020 to tighten restrictions on prescribing of the products, in response to data suggesting they were still being prescribed to “patients who are not opioid tolerant.”
Researchers in 2019 had questioned the FDA for failing to crack down on inappropriate prescribing of the painkillers, with “as many as half of patients” taking the drugs ineligible for them.
In 2022, Teva said it had settled with lawsuits from state and local governments that had accused the company of promoting Actiq and other painkillers for patients without cancer and downplaying addiction risks.
On a website run by Teva and the other pharmaceutical manufacturers behind other formulations in this class of painkillers, they say that providers and doctors should work with their patients to “transition to a non-TIRF treatment.”
The FDA signed off on warnings about the looming discontinuation last month for Actiq and Fentora, FDA records show, in response to a request submitted by the drugmaker.
“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 says.
