FDA recalls Orofer FCM after Saifee patient’s death

Mumbai: A month after a 55-year-old man died of suspected adverse drug reaction when he was injected with Orofer FCM (ferric carboxymaltose), an iron supplement given to patients to increase hemoglobin, at Saifee Hospital, in Charni Road, Food and Drugs Administration (FDA)-Maharashtra issued a circular on Monday to recall all the injections (500 mg /10 ml) manufactured by Emcure Pharmaceuticals Ltd, from across the country

Mumbai: A month after a 55-year-old man died of suspected adverse drug reaction when he was injected with Orofer FCM (ferric carboxymaltose), an iron supplement given to patients to increase hemoglobin, at Saifee Hospital, in Charni Road, Food and Drugs Administration (FDA)-Maharashtra issued a circular on Monday to recall all the injections (500 mg /10 ml) manufactured by Emcure Pharmaceuticals Ltd, from across the country.

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Emcure Pharmaceuticals Ltd’s corporate office is in Hinjewadi, Pune, while the drug is manufactured from facilities in Thane and Bhosari, a Pune suburb. The company has a well-oiled distribution system, its primary distributor being in Delhi.

According to hospital sources, 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),” said the source. 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.

Hospital administration claimed that it had reported the case of the death due to adverse drug reaction to the Central Drugs Standard Control Organisation, Government of India.

“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,” said the hospital source.

Given the inaction by the Central authority, on November 4, the deceased’s wife wrote to FDA-Maharashtra requesting an inquiry. Following this, the FDA team visited Saifee Hospital on November 10 and took seven vials from the same stock that the hospital had set aside. The stock is now being sent for tests along with other samples from the manufacturer’s godown Hadapsar, Pune.

“We received the complaint from the patient’s relative, on the basis of which we took the samples and investigated,” said Gaurishankar Byale, the FDA officer.

After FDA’s notice, Emcure, announced that the entire batch of the drug will be recalled from the market. Joint Commissioner (Drugs), Pune Division, S B Patil, in his email communication to the drug controllers on November 21 stated, “You are requested to stop use of the drug under your jurisdiction and recall the stock from the market.”

Patil also added that the company has stated that there could be spurious drugs in the market, which may have caused the suspected adverse reaction in the Mumbai patient. “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,” he said.

An Emcure spokesperson stated, “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.”