The FDA has issued a recall for thousands of bottles of duloxetine, a commonly prescribed generic antidepressant marketed as Cymbalta, due to the presence of the toxic chemical nitrosamine.

The voluntary recall of over 7,000 bottles of antidepressant drug duloxetine began on October 10, an SNRI (selective serotonin/ norepinephrine reuptake inhibitor) used to treat conditions like anxiety, depression, and other mood disorders.

How will the public know if the medication is recalled?

• The FDA issued a Class II recall, duloxetine 20 mg delayed-released capsules. This classification indicated that the product may cause temporary or medically reversible adverse effects, with a low probability of serious harm.

• The drugs were manufactured by Towa Pharmaceuticals Europe.

The affected duloxetine 20 mg delayed-released capsules are packaged in 500-count bottles, have a lot number of 220128, and expire in December 2024.

• Though it is a voluntary recall, the FDA advises consumers to consult their healthcare providers if their medication matches the affected lot.

• The FDA and Towa Pharmaceuticals Europe echoed, not to discontinue medications due to potential nitrosamine impurities.

• Updates on the findings will be provided to the public as the investigation progresses.

What is the potential risk?

The FDA clarifies that low levels of nitrosamine are generally safe and would not pose health risks even over a lifetime of exposure. However, elevated levels of N-nitroso-duloxetine pose a potential cancer risk and become toxic according to the U.S. National Library of Medicine.

• Nitrosamine may be present in drugs due to multiple factors, including:

  • The manufacturing process of the drug

  • the drug's chemical structure

  • Storage or packaging conditions

• Nitrosamines can also be formed when certain foods and drugs are metabolized in the body

• The FDA is actively testing and researching potential sources of nitrosamines in drugs.

In collaboration with global regulatory bodies, the FDA has established acceptable limits for nitrosamine in drugs. Any medication surpassing these limits is recommended for the recall.

(Input from various sources)

(Rehash/Josna Lewis/MSM)