FDA has taken action to recall duloxetine capsules due to the dangerous presence of a potentially cancer-causing impurity, raising health alarms nationwide.
At a Glance
- The FDA has recalled 7,107 bottles of duloxetine due to the presence of N-nitroso-duloxetine.
- This contaminant is thought to increase cancer risk at high concentrations.
- The recall, initiated on October 10, affects 20mg capsules with specific lot numbers and expiry dates.
- Patients should consult with their healthcare providers before discontinuing use.
Understanding the Recall
On October 10, the FDA initiated a recall of 7,107 bottles of duloxetine due to the presence of N-nitroso-duloxetine, a potential carcinogen. This impurity exceeds the recommended limits, which poses a cancer risk over time. Breckenridge Pharmaceutical is leading this recall, focusing on 20mg capsules sold in 500-count bottles, identified by lot number 220128 with an expiration date in December 2024.
Duloxetine, known by the brand name Cymbalta, is used to treat depression and anxiety. The recall is classified as Class II, indicating that it could cause medically reversible adverse health effects, with a minimal likelihood of severe consequences. Breckenridge wishes to alert the public to mitigate health hazards.
Duloxetine Recall: FDA Flags Carcinogenic Risk for Popular Antidepressant https://t.co/kyhHo5Q8b8 via @peoplespharmacy
— The Peoples Pharmacy (@PeoplesPharmacy) October 27, 2024
Nitrosamines: A Familiar Concern
N-nitroso-duloxetine is a compound suspected to increase cancer risk if absorbed above acceptable levels. The FDA, working with global regulatory bodies, has set intake limits for nitrosamines. This recall follows numerous recalls of drugs due to nitrosamine impurities, emphasizing thorough safety standards in drug production.
“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” per the FDA.
Impurities can emerge during production or storage, highlighting the critical need for strict monitoring. Such thorough standards protect against potential adverse effects.
Steps for Patients and Providers
The FDA refrained from issuing direct guidance but advised patients to consult with healthcare providers. Ensuring patients do not abruptly halt medications is critical, emphasizing the need for alternatives. Pharmacists are urged to offer uncontaminated options and communicate with patients about unaffected lots.
“FDA, in collaboration with regulatory counterparts around the world, has set internationally-recognized acceptable daily intake limits for nitrosamines. Nitrosamines below this level are acceptable in drugs. If drugs contain levels of nitrosamines above the acceptable daily intake limit, FDA recommends these drugs be recalled by the manufacturer,” the FDA stated.
Healthcare professionals play a pivotal role in educating patients on alternatives to maintain effective treatment regimens safely, underscoring the necessity for vigilant pharmaceutical practices.
