Antidepressant recalled over possible contamination with cancer-causing chemical
Hundreds of thousands of bottles of a hugely popular antidepressant have been recalled over fears that they could contain a cancer-causing chemical.More than 370,000 bottles of duloxetine delayed-release capsules, sold by New Jersey-based Breckenridge Pharmaceuticals and commonly known as Cymbalta, were subject to the warning.The FDA raised the alarm after tests found the capsules contained higher than permitted levels of N-nitroso-duloxetine, which is considered to be a probable carcinogen to humans.No illnesses have been reported to date, but the agency warned this was a Class II recall, meaning exposure to the product could cause temporary or medically reversible events.The recall includes 360,000 bottles of 60 milligram (mg) capsules, sold in bottles containing 90 or 1,000 capsules.It also includes 14,000 bottles of 30mg capsules, sold in bottles containing 1,000 capsules. The prescription-only drugs were sold nationwide and have best-before dates up to May next year.No advice has been issued by officials on what to do if you have the recalled drugs at home, but, typically, people are advised to contact their doctors to seek alternatives. More than 370,000 bottles of duloxetine delayed-release capsules have been recalled
Physicians warn online that abruptly stopping the drug can lead to depression, fatigue, headaches and insomnia, or difficulty falling asleep.Duloxetine, also sold as Irenka, is one of the most popular antidepressants in the US and has about 18 million prescriptions written every year.Doctors use it to treat depression, anxiety or pain caused by nerve damage associated with diabetes. It may also be prescribed to treat fibromyalgia.The recall was revealed as two notices on the FDA's website. No press release has been issued as yet.The drug was manufactured by Towa Pharmaceuticals Europe, based in Spain, and distributed in the US by Breckenridge Pharmaceuticals. N-nitroso-duloxetine is a byproduct that can accidentally form during the manufacturing process.A list of the lot numbers in the recall is available in the first notice and second notice issued on the FDA website. People are exposed to trace levels of this chemical from the environment daily, but the FDA has safe limits for it in medications, at 26.5 nanograms per day. Shown above are the 90-capsule and 1,000-capsule bottles from Breckenridge that have been recalled Shown above is the 1,000-capsule 30mg duloxetine that has been recalled Experts say that prolonged exposure to higher levels of this chemical may raise the risk of developing cancer. Previous research in animals has linked nitrosamines, the group of chemicals that includes N-nitroso-duloxetine, to cancer in the colon and liver. The alert is at least the second recall of Breckenridge Pharmaceuticals-distributed antidepressants this year. In April, 165,000 bottles of its 60mg duloxetine delayed-release capsules were recalled over the presence of the same potentially cancer-causing chemical. These were all in 90-count bottles.In 2024, Breckenridge recalled 7,100 bottles of its 20mg duloxetine delayed-release capsules that were sold in 500-count bottles.
