The medications, known as transmucosal immediate release fentanyl, include products such as Actiq, a fentanyl lozenge on a stick often referred to as a “fentanyl lollipop,” and fentora, a dissolvable tablet. These drugs, initially approved for managing breakthrough pain in cancer patients who are opioid tolerant, have been linked to fueling the opioid overdose crisis in the U.S., CBS News reported Sept.19.
The decision to cease production comes after decades of controversy and lawsuits surrounding the marketing practices for these drugs. Both TIRF drugs were aggressively marketed beyond their approved use, leading to widespread “off-label” prescriptions, the report said.
Despite FDA restrictions, drugmakers, including Cephalon and later its parent company Teva pharmaceuticals, faced lawsuits for downplaying the drug’s addiction risks and promoting the medication to patients without cancer, according to CBS News.
The FDA said in a Sept. 16 news release that patients already using the drugs may continue treatment while supplies last, while encouraging healthcare providers to transition patients to alternative therapies.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
