Made-in-India ADHD medicine recalled from US market: What should Indian customers do? Doctor explains

Due to the detection of impurities, an ADHD (Attention Deficit Hyperactivity Disorder) medication by Glenmark Pharmaceuticals Inc, a subsidiary of Mumbai-based Glenmark Pharma, was recently recalled from the US market. Around 15 lakh bottles of Atomoxetine capsules in various strengths were recalled due to CGMP (Current Good Manufacturing Practices) deviations. The US FDA (Food and Drug Administration) said that the presence of N-Nitroso Atomoxetine impurity, above the FDA-recommended limit, was detected in these tablets. As per reports, the market removal is a Class II recall, which means that exposure to the medicine can cause temporary or medically reversible health issues. Renowned Psychiatrist Dr C J John says that Atomoxetine is a tablet that is commonly prescribed in India as well. “However, we do not have a mechanism or a centralised complaint number to raise our concerns if we see such issues with medicines. All that doctors can do is probably alert the supplier or give alternative medications to patients,” he says. What can Indian patients who are using the medicine do in such a case?

Safety tips for India
At a time when ADHD is commonly diagnosed in children in India and the tablet a usual prescription, what users can do is to be alert, says the doctor. “ADHD medicines are supposed to help manage its symptoms by improving focus, control hyperactivity and help with attentiveness. However, if it isn’t doing the same and you observe side effects, alert the doctor who prescribed of the same and decide on how to proceed,” he explains.
If impurities like N-Nitroso Atomoxetine are present, it can cause health risks as it is a potential carcinogen, aka cancer-causing substance, according to various health platforms. Long-term exposure to it can also damage DNA and cells and cause organ damage.
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