7,000 Bottles Of Antidepressants Recalled By FDA
The Food and Drug Administration recalled more than 7,000 bottles of an antidepressant due to a chemical, according to a report in USA Today. The recall was initiated earlier this month on October 10. The antidepressant, Duloxetine, reportedly known under brands like Cymbalta is used to treat mental health conditions like anxiety and depression.
The report says that the product was distributed across the country and manufactured by Towa Pharmaceutical Europe. FDA says that the medication had the “presence” of nitrosamine drug substance impurity, N-nitroso-duloxetine.
According to FDA, nitrosamine impurities “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.” However, it added, “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.”
FDA says that #220128 was the recalled lot which had an expiry date of December 2024.
Nitrosamines are chemical compounds, some of which are carcinogenic. They are formed by the reaction between nitrites and secondary amines. They can happen in several products such as processed meats, cosmetics, rubber and pharmaceuticals among others.
Nitrosamines can be a cause of concern because they can form during food processing or preservation, especially when nitrites are used to prevent bacterial growth. High cooking temperatures, such as frying or grilling can also help in their formation.
In the human body, nitrosamines are linked to an increased risk of cancers, especially, stomach, oesophagus and liver cancers as they can cause DNA damage.
Regulatory agencies have established limits for nitrosamine levels in pharmaceuticals and foods to reduce these risks. To reduce exposure, it is important to limit the consumption of processed meats, use less nitrate-preserved foods and choose fresh and minimally processed ingredients.
There have several cases where nitrosamines have been discovered in medications in recent years. This has led to recalls and increased scrutiny of manufacturing processes. More than 12 million bottles of blood pressure-lowering drugs such as valsartan and losartan have been removed from the market since 2018 because they had nitrosamines.
The same family of contaminants triggered past recalls of the heartburn drug Zantac, the diabetes drug metformin and the smoking cessation medication Chantix.
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