The U.S. Food and Drug Administration (FDA) has issued a recall for more than 7,100 bottles of the antidepressant duloxetine due to the possible presence of a cancer-causing impurity. Duloxetine, commonly prescribed to treat depression and anxiety, is part of a drug class known as selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It is also sold under the popular brand name, Cymbalta.
FDA headquarters is on the White Oak campus in Silver Spring, Maryland
The initial recall, announced by the FDA on October 10, highlighted concerns over a substance called a nitrosamine impurity found in the medication. The impurity was detected above the FDA's acceptable safety limits, leading to the recall of duloxetine delayed-release capsules manufactured by Towa Pharmaceutical Europe.
The FDA has categorized this recall as Class II, which indicates that the use of the product could potentially lead to temporary or medically reversible health problems. The agency also noted that the risk of severe health consequences is considered low, but it remains a concern for those exposed to the impurity over extended periods.
Nitrosamine impurities are known to increase cancer risk when individuals are exposed to high levels for a prolonged time. In this particular case, the recall involves 7,107 bottles of 20 mg duloxetine delayed-release capsules, each containing 500 pills. These capsules were produced by Towa Pharmaceutical Europe.
Despite requests for comments, neither Towa Pharmaceutical Europe nor its U.S. subsidiary, Breckenridge Pharmaceutical Inc., has responded. However, Towa has expressed its commitment to working with the FDA and other regulatory bodies to address the issue, stating, "Patient safety remains our top priority."
The FDA advises anyone currently taking duloxetine who may have concerns about nitrosamine impurities to consult their healthcare provider before stopping the medication. Patients are encouraged to discuss any risks and explore alternative treatments with their doctors.
For more information on the recall and guidance for affected patients, the FDA's website provides additional resources and updates.
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