Pfizer recalls anti-anxiety drug 'Ativan' from Indian markets; doctors say 'patient safety paramount'

Hyderabad: Pfizer has recalled Ativan 1mg and Ativan 2mg Tablets (Lorazepam 1mg and 2mg Tablets I.P.) from the Indian market.

The recall is in response to a revised manufacturing protocol, following consultation with the Directorate of Food and Drug Administration in Goa, India.

The recall pertains to products manufactured from December 2022 onwards, and there are no reported adverse events associated with the impacted products.

Rajasekhar Parcha, representing Goapptiv Private Limited, conveyed the recall information, stating, "Please note that this recall is only for the stock manufactured from Dec'2022 onwards."

The directive urges wholesalers to return the affected product batches to the nearest GoApptiv super distributor. In case of product unavailability, wholesalers are requested to submit a "Nil Stock Statement" for appropriate record-keeping.

“This move ensures compliance with regulatory standards and emphasizes Pfizer's commitment to quality and safety. The recall aligns with the company's dedication to maintaining the highest manufacturing standards, as advised by the Directorate of Food and Drug Administration” said Parcha.

Medical aspect of Ativan

Ativan is used in treating anxiety. Lorazepam, the active ingredient, belongs to the benzodiazepine class, acting on the central nervous system to produce a calming effect by enhancing the effects of the natural chemical GABA.

Some potential side effects of Ativan can be drowsiness, dizziness, loss of coordination, headache, nausea, blurred vision, and changes in sexual interest, ability, or appetite.

While no adverse events have been reported with the impacted products, it's crucial to remain vigilant.

As an added layer, quotes from Hyderabad doctors provide local perspectives, enhancing the awareness and understanding of the recall's significance. L

This voluntary recall of Ativan 1mg and Ativan 2mg Tablets (Lorazepam 1mg and 2mg Tablets I.P.) in the Indian market has prompted a closer look at the implications and medical considerations associated with this move.

"As healthcare providers, our priority is patient safety. The voluntary recall by Pfizer demonstrates a commitment to ensuring that the medications meet the highest standards. Patients and healthcare professionals need to be informed about such recalls to make well-informed decisions," reacted Dr. Ananya Sharma, a prominent Hyderabad-based psychiatrist.

Discussing a local perspective, Dr. Rahul Desai, a neurologist practicing in Hyderabad, said: "Lorazepam, the active ingredient in Ativan, is commonly prescribed for anxiety disorders. While the recall is a precautionary measure, patients need to consult their healthcare providers for guidance on alternative medications or management strategies during this period."

The recall is rooted in Pfizer's adherence to a revised manufacturing protocol, as clarified by Dr. Priya Reddy, a pharmacologist based in Hyderabad: "Manufacturing standards play a crucial role in ensuring the quality and safety of pharmaceutical products. This recall, driven by a commitment to regulatory compliance, aims to address any potential deviations from these standards."

Despite there being no reported adverse events linked to the impacted Ativan products, Dr. Karthik Rajan, a Hyderabad-based emergency medicine specialist, emphasized the need for vigilance: "The absence of reported adverse events doesn't negate the importance of the recall. Patients who have been prescribed Ativan should reach out to their healthcare providers promptly to discuss any concerns or to seek guidance on alternative medications."