The US Food and Drug Administration (FDA) recently announced that TIRF (Transmucosal Immediate-Release Fentanyl) drugs, which include fentanyl lollipops and similar products, will no longer be manufactured.
These drugs, which contain rapid-release fentanyl, have been used for years to treat breakthrough pain in cancer patients who have already developed tolerance to ongoing opioids. However, their future is now shaped by years of research, litigation and changing public perceptions about the use of potent opioids like fentanyl.
The FDA, in a statement issued this week, explained that TIRF drugs, Used primarily to treat sudden, severe pain episodes in patients receiving ongoing opioid therapywill no longer be available due to the decision of the manufacturers themselves to withdraw them from the market.
Teva Pharmaceuticals, which acquired Cephalon in 2011 — the company that originally developed products such as Actiq, a lollipop-shaped fentanyl pill, and Fentora, a fast-dissolving oral tablet — has decided to stop producing these drugs as of September 30, 2024.
The context behind this decision has roots in decades of controversy. Since their initial approval, TIRF products have been the subject of controversy due to their marketing and misuse.
Over the years, lawsuits and criticism have swirled around the promotion of these fast-acting painkillers, accusing pharmaceutical companies of selling them too aggressively, downplaying the risks of addiction and recommending them to patients who did not meet the criteria for safe use, particularly those who did not have cancer.
One of the key moments in the history of these drugs took place in 2020, when The FDA has implemented stricter restrictions on its prescriptionThis was in response to alarming data indicating widespread misuse of TIRF medications in patients who had not developed opioid tolerance, significantly increasing the risk of overdose and addiction.
Multiple demands
These changes came after years of evidence suggesting that abuse of these drugs had contributed to the growing opioid crisis in the United States.
Teva Pharmaceuticals has been the leading manufacturer of these drugs since its acquisition of Cephalon in 2011. During that decade, Actiq, one of the best-known products in the TIRF line, had a market value of about $173 million annually.
However, pressure on the company increased when it became embroiled in multiple lawsuits filed by state and local governments. In 2022, Teva settled several of these lawsuits alleging it had promoted products like Actiq to ineligible patients and downplayed the risks associated with fentanyl.
Although Teva has decided to stop producing and marketing TIRF drugs, the FDA clarified that it was not the agency that requested such suspension. In its statementThe FDA also stressed that it does not have the ability to force any company to manufacture or distribute drugs.since its function is limited to regulating the safety and efficacy of drugs that reach the market.
However, the agency reaffirmed its commitment to ensuring that patients with chronic pain and cancer can continue to access safe and effective treatments for their care.
With the suspension of production of TIRF drugs, an important chapter in the history of opioid analgesics has come to a close. These products, which were once considered revolutionary for the treatment of pain, have left a trail of controversy, addiction and litigation that has affected both patients and pharmaceutical companies.
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