FDA Says Drug Makers Will Stop Producing Fentanyl 'Lollipops'

Follow Drugslib on

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 20, 2024.

By Robin Foster HealthDay Reporter

FRIDAY, Sept. 20, 2024 -- Controversial fentanyl lollipops and similar products will no longer be made by drug makers, the U.S. Food and Drug Administration has announced.

Known as TIRF medications, these products contain fentanyl and are used to manage breakthrough pain in cancer patients who have become tolerant to around-the-clock opioid therapy, the FDA said in a statement released this week.

The decision by drug makers to stop selling such medicines follows decades of investigations and lawsuits against the drugmakers that had marketed the fast-acting painkillers too aggressively, CBS News reported.

In 2020, the FDA first tightened prescribing restrictions on the products, in response to data suggesting they were being given to patients who are not opioid-tolerant.

Drugmaker Cephalon had the FDA's approval to market these drugs for years under brand names like Actiq, a sweetened lozenge on a stick, or Fentora, a tablet that dissolves in the mouth.

Generic pharmaceutical manufacturer Teva Pharmaceuticals acquired Cephalon in 2011, when the market for Actiq was worth around $173 million a year, CBS News reported.

Teva officials did not respond Thursday to a request for comment on why it will stop selling the products, CBS News reported.

In 2022, Teva settled lawsuits from state and local governments that had accused the company of promoting Actiq and other powerful fentanyl painkillers for patients without cancer and downplaying addiction risks.

Teva will stop selling the products on Sept. 30, the FDA said.

"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 added.

Sources

  • U.S. Food and Drug Administration, news release, Sept. 16, 2024
  • CBS News

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2024-09-21 12:00

    Read more

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords