United States: The manufacturers of those not so health-friendly fentanyl painkillers are to keep off the shelves of the market at the close of this month, the FDA announced.
This means there will be withdrawal of the controversial “fentanyl lollipops” as well as other types of formulations, which have been blamed for playing a part in fueling the opioid overdose epidemic.
More about the news
The pause in the sales of the drugs, also known as transmucosal immediate-release fentanyl/TIRF medications, came after several research and litigations against the drug manufacturers who had promoted quick-acting and high-intensity painkillers.
According to the FDA, “As of the date of this announcement, there are fewer than 150 patients receiving treatment with TIRF medicines,” CBS News reported.
Those who are at the moment on one of these medicines may, however, continue to be treated with the medicine as long as it is available.
What more are the officials stating?
The FDA had allowed a drugmaker, Cephalon, to market these drugs, originally under brand names like Actiq, a sweetened lozenge on a stick, and a Fentora tablet that dissolved in the mouth of cancer patients who developed a tolerance for inferior opioids.
However, investigators quickly learned the company’s salespeople were violating FDA regulations regarding the limitation of the marketing of the painkiller that directed doctors to prescribe the addictive drugs “off-label” beyond the specific uses approved by the FDA.
Additionally, Teva Pharmaceuticals – a generic pharmaceutical manufacturer, needed to acquire Cephalon in 2011, and at this time, the market for Actiq was approximately USD 173 million per year.
The FDA in 2020 strengthened restrictions to the dispensing of the products as evidence they were still being prescribed to ‘patients who are not opioid-tolerant’ persisted, CBS News reported.
In 2019, researchers accused the FDA of not acting on the issue of the prescription of painkillers, with “as many as half of patients” taking the drugs ineligible for them.
Teva stated in 2022 that it had resolved legal claims by state and local governments that accused the company of marketing Actiq and other opioids for patients who did not have cancer or immortalizing the risks of addiction.
Moreover, as the agency stated, “FDA did not request this discontinuation. It is important to note that the 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.”