Patient dies from suspected drug reaction to Emcure Pharma's Orofer FCM, Maha FDA issues nationwide recall

Acting on the complaint moved by the deceased's wife, the Food and Drugs Administration (FDA), Maharashtra issued a circular on Monday to recall all the injections (500 mg /10 ml) manufactured by Emcure Pharma from across the country. Orofer FCM injection is used to treat iron deficiency anaemia.

On November 4, the deceased's wife wrote to FDA-Maharashtra requesting an inquiry in the matter.

The deceased routinely came to Saifee Hospital for check-ups. "He was anaemic and regularly took the injection at our hospital. He was administered Orofer FCM on October 12, at the outdoor patient department (OPD)," claimed the hospital sources.

As soon as he took the injection, he had an anaphylactic reaction, his blood pressure dropped suddenly and the airways narrowed, which led to breathing issues. He died soon after.

According to a recent media report in HT, the hospital administration claimed that it had reported the case of the death due to adverse drug reaction to the Central Drugs Standard Control Organisation (CDSCO), Government of India. However, the deceased's spouse stepped in, filing a complaint with the State FDA in wake of the inaction by the Central authority.

"We tried our best to revive him. We are in shock too. We immediately informed the concerned authorities about the death and stopped using the drug from our stock, while waiting for further instructions from the FDA," the hospital source added.

Accordingly, the FDA team visited Saifee Hospital on November 10 and took seven vials from the same stock that the hospital had set aside. To mention, the drug maker has its corporate office in Hinjewadi, Pune, while the drug is manufactured from facilities in Thane and Bhosari, a Pune suburb.

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"We received the complaint from the patient's relative, on the basis of which we took the samples and investigated," Gaurishankar Byale, the FDA officer told HT

Subsequently, Emcure Pharmaceuticals, the manufacturer, was asked to recall the particular batch of the drug. On November 21 in his email communication, S B Patil, Joint Commissioner (Drugs) FDA stated, "You are requested to stop use of the drug under your jurisdiction and recall the stock from the market."

In line with the FDA notice, Emcure, announced that the entire batch of the drug will be recalled from the market.

However, the company opined that there could be spurious drugs available in the market in the name of Orofer injection and because of such spurious drug the suspected adverse reaction might have taken place.

An Emcure spokesperson told Medical Dialogues, "The matter is under investigation. We had earlier filed complaints regarding counterfeit products with various authorities including FDA and the police, as we learnt of incidences of adverse drug reaction due to counterfeit products in the market."

"As an abundance of precaution and at the direction of the authorities, we are recalling the mentioned batch, even though our product is of standard quality," it added.

The company also told the FDA that spurious versions of one of its other drugs was already being sold in the market.

The Mumbai FDA team is carrying out a probe in the matter and samples from the batch of the drug have been collected from the distributors and sent for analysis.

"We have informed the Delhi government that the stock which is under review, came from Delhi. The company also informed us that spurious versions of one of its other drugs was being sold in the market," Patil told PTI.