In a major drug recall, over 7000 bottles of Duloxetine, a popular antidepressant drug, were pulled off-the shelves on October 23, 2024 due to the presence of a chemical known to cause cancer called nitrosamine. The company recalled over seven thousand duloxetine delayed-release capsules after discovering that a particular nitrosamine impurity exceeded its acceptable level. The company that makes those duloxetine capsules, Towa Pharmaceutical, is Japan’s second biggest generic pharmaceutical company. It opened its International office in USA for which Breckenridge is the American affiliate. The company recently announced duloxetine recall.
Duloxetine – The 31st Most Prescribed Medication in the USA
Duloxetine is an FDA approved antidepressant medicine that is also used in managing anxiety, fibromyalgia and the persistent pain of diabetic neuropathy and other musculoskeletal pain. Duloxetine accounted for approximately 14 million prescriptions that made the drug the 31st most prescribed medication in the USA in 2022. It is used in major depressive disorder (MDD) and generalized anxiety disorder (GAD). It is a prescription-only medicine and larger doses can cause severe adverse effects and toxicity. The drug must be taken only on the advice of a healthcare practitioner.
Why Duloxetine recall? Which batches of duloxetine recalled?
Recently, the firm issued a notice indicating “Please be advised that Breckenridge Pharmaceutical, Inc. (Breckenridge) is performing a Retail Level Class II Recall of Duloxetine Delayed-Release Capsules, USP, 20mg, 30mg, 60mg, manufactured by Towa Pharmaceutical Europe, S.L”.
Different lots were pulled off including the 90-count, 500-count and 1000-count bottles with expiry dates of varying periods from November 2024 to December 2025.
As per USFDA, 7107 bottles of duloxetine delayed release capsules 20mg, 500-count bottles manufactured by Towa Pharmaceutical, Europe, S.L. Distributed by BPI, NDC Lot # 220128 and expiry date 12/2024 were recalled voluntarily by the firm Breckenridge Pharmaceutical, Inc. The recall was initiated on October 10. https://www.accessdata.fda.gov/scripts/ires/. The reason was presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the acceptable limit.
What are Nitrosamines?
Nitrosamines are usually found in many different products, water and foods. The processed meats, dairy products, alcohol, cosmetics, cigarette smoke and even vegetables contain a little amount of nitrosamine that exposes one to that quantity. However, high amounts of nitrosamines, far beyond the permissible limits and for a prolonged duration of time, are potent carcinogens and potentially increases the risk of cancer. They are capable of producing cancer in various organs such as lungs, brain, liver, kidney, bladder etc. FDA, therefore, mandates testing of the possible sources of nitrosamine in drugs. Among the sources, improper storage conditions and certain impurities as well as the chemical reactions in the process of drug manufacturing can all contribute.
What is Class II Recall by USFDA?
United States Food and Drug Administration (US FDA) defines recall as a process of withdrawing or correcting products who does not conform to laws of US FDA. It is a voluntary activity undertaken by manufacturers and distributors to protect the health and well-being of the public. In case of duloxetine, the manufacturer is Towa Pharmaceutical and the distributor is Breckenridge.
The FDA categorizes recall into three classes:
- Class I Recall –product that causes serious adverse health consequences or death
- Class II Recall – product that causes temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III Recall – product is unlikely to cause adverse health consequences.
The voluntary recall by Breckenridge, distributor of Towa Pharmaceuticals, was termed Class II recall by USFDA. While the recall has been carried out but the potential damage done has yet to be measured.
FDA published a guidance document, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) in Apr 2023. This guidance document provides the recommendations for acceptable limits of NDSRIs based on the predicted carcinogenic potency.
What to do if I am already taking Duloxetine?
Towa Pharmaceuticals are not the only manufacturers for Duloxetine. The drug Duloxetine is marketed by some other brand names as well, which includes Cymbalta, Drizalma Sprinkle and Irenka, etc. However, these brands are currently not affected or recalled and can be used. It is only some specific batches of generic version of Duloxetine manufactured by Towa Pharmaceuticals and distributed by Breckenridge and sold under the brand name Cymbalta that is recalled.
Despite the recall warning, individuals already on one of the affected lots of duloxetine delayed-release capsules should not stop the medication abruptly because severe withdrawal related adverse effects results from abrupt discontinuation. A patient already taking the medication should meet their doctor immediately and should discontinue the drug only after the advice from their healthcare provider.
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