This recall comes afterover 7,000 bottles of the same antidepressantwere recalled in October.
This is the second-highest category of the FDAs three recall classes.
Long-term exposure to high levels of nitrosamine impurities, like N-nitroso-duloxetine, may increase cancer risk.
Dhiraj Singh / Bloomberg / Getty Images.
The California Board of Pharmacy has a comprehensive list of recalled duloxetinehere.
How Did the Drugs Get Contaminated?
It remains unclear how the duloxetine antidepressants became contaminated.
However, contamination could occur during manufacturing or storage.
Nitrosamines are found in the environment, including in water and certain foods.
The FDA sets acceptable daily limits for nitrosamine exposure but notes that its impossible to avoid these compounds entirely.
Cumulative lifetime exposure is likely the most important factor for many cancer-causing chemicals, she added.
Drugmakers may recall products if nitrosamine levels exceed set limits.
What Should You Do If You Take Duloxetine?
This drug treats anxiety, depression, and certain pain conditions.
There are certainly alternatives available.
There are other SNRIs available, including venlafaxine (Effexor) and desvenlafaxine (Pristiq), Alan said.
Speak with your healthcare provider before stopping treatment, as abrupt discontinuation can cause withdrawal symptoms.
National Library of Medicine: PubChem.N-nitroso duloxetine.
Food and Drug Administration.Recalls background and definitions.
Food and Drug Administration.Information about nitrosamine impurities in medications.
