Pharmaceuticals suspend sales of controversial fentanyl painkillers
Drugmakers will stop selling controversial fentanyl medications, blamed for fueling the opioid crisis, following FDA investigations and lawsuits. Patients may continue treatment while supplies last.
Pharmaceutical manufacturers have announced that they will cease the distribution of a controversial class of fentanyl medications known as transmucosal immediate release fentanyl (TIRF) products by the end of this month. This decision, communicated by the Food and Drug Administration (FDA) earlier this week, puts an end to a contentious brand of "fentanyl lollipops" and other formulations that have been implicated in exacerbating the opioid overdose crisis.
The Concerns Surrounding TIRF Medications
Decades of investigations and legal actions against these drugmakers have shed light on the aggressive marketing tactics employed to promote these potent pain relievers. The cessation of TIRF sales is a response to concerns over the role these products have played in contributing to the opioid epidemic. The FDA noted that as of the time of the announcement, there were fewer than 150 patients currently undergoing treatment with TIRF medications.
The controversial TIRF medications, marketed under brand names such as Actiq and Fentora, were initially sanctioned by the FDA for use in cancer patients who had developed a tolerance to less powerful opioids. Despite this narrow scope of approval, investigators discovered that the sales teams of the drug manufacturers were not adhering to FDA regulations. Instead, they were encouraging healthcare providers to prescribe these highly addictive drugs for "off-label" uses beyond the approved patient population.
Acquisitions and Settlements
In 2011, Teva Pharmaceuticals, a generic pharmaceutical manufacturer, acquired Cephalon, the company behind the TIRF medications, at a time when the market for Actiq was valued at approximately $173 million annually. The reasons behind Teva's decision to halt the sale of these products remain unclear, as the company did not provide a response to inquiries on the matter.
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