Following the death of 47-year-old Saira Shaikh hours after suffering from adverse drug reaction (ADR) in civic run Kurla Bhabha Hospital, FDA officials have instructed stockists and hospitals to stop use of cefotaxime injection manufactured under the brand name, Sanocef, by Sanjivini Parenteral Drugs, Navi Mumbai.

Food and Drug Administration (FDA) officials seized treatment records of the deceased who died within 24 hours of having taken the antibiotic jab of Schedule H1 drugs - cefotaxime and ceftriaxone. However, state FDA says death could not yet be directly linked to a drug reaction for which samples of cefotaxime, ceftriaxone and water for sterility have been drawn for investigation and analysis.

Says a senior FDA official, "We are investigating the samples for carrying microbiology and sterility tests. Over 50, 000 samples have already been distributed to 14 hospitals in the city and no such drug reaction has been reported as yet. The incidents of an adverse drug reaction were reported only in the female ward of the civic run Bhabha Hospital and no adverse reaction has been observed in patients of gents ward. It will take around 14 days to arrive at a conclusion whether it is a clear case related adverse drug reaction."

Based on the scientific literature available, pharma expert Dr Bijoy Panda explains that the drug injected should be checked for degradation, the allergic history for the penicillins and cephalosporins of the dead patient should be cross verified. Ceftriaxone is the common drug which is associated with adverse drug reactions. Many of the reactions subside after the discontinuation of the drug.

"Fatal events have been reported where ceftriaxone is administered to the patient who had a previous history of allergic reactions to ceftriaxone, penicillin or both. Ceftriaxone induced hepatic or renal injury and death is very rare, but few have been reported till date," he adds.

"The manufacturing units of drug cefotaxime in Navi Mumbai have been inspected and an email has been sent to the drug controller in Himachal Pradesh to investigate the case from their end," the FDA official explains.   

The death of woman, which came a fortnight after 18 children in Bhiwandi in Maharashtra had a similar reaction to one of the drugs - cefotaxime. Most of the women admitted to the Kurla hospital were undergoing treatment for fever, typhoid, malaria and other seasonal ailments. The adverse effects started soon after they were injected with cefotaxime and ceftriaxone, antibiotics commonly used for bacterial infections.

Meanwhile, a three member expert committee consisting of a microbiologist, a clinical pharmacologist and a physician has been constituted to investigate the cause of ADR. The other inquiry committee under Dr Vidya Thakur, who is in charge of BMC peripheral hospitals in eastern suburbs, will check whether drugs were administered correctly.

Sanjivini Parenteral Limited, through an official statement, explained, "However, the use of the batch (of medicines) will be stopped as a precautionary measure until the investigation is complete. We here by assure you that the products manufactured are of standard quality."

FDA officials have instructed stockists and hospitals to stop use of over thousand vials of ceftriaxone injection (batch number 314-331) manufactured under the brand name, Sefxim, by Zee Labs, Himachal Pradesh, and sterile water for injection (batch number 3WT-259) manufactured by Parenteral Drugs Limited, Baddi, Himachal Pradesh, until the investigation is completed.

India lacks a mechanism to report and monitor adverse drug reactions (ADR) as is followed globally. Prevention of incorrect use of medicines and awareness amongst the patients and pharmacist community is the need of the hour. Around 30 lakh people in India are impacted by ADR and over four crore globally. Solution to the problem lies in avoiding self medication and strict implementation of the law by the regulatory agency as ADR is the fourth largest killer in the world.