Maharashtra Food & Drug Administration's (FDA) Mumbai testing lab, in its recent report, says the concoction of drugs ceftriaxone and cefotaxime which led to adverse reactions in patients at three state run government hospitals a fortnight ago in Mumbai are of standard quality. Maharashtra FDA is also in the process of directing stockists and hospitals to allow use of ceftriaxone and cefotaxime.
Maharashtra FDA had started a probe a fortnight ago into three other cases of adverse drug reactions at the state-run Indira Gandhi Memorial Hospital (IGM) in Bhiwandi and later at BMC-run K B Bhabha and Rajawadi hospitals in Ghatkopar. In the case of the Bhiwandi and Ghatkopar hospitals, all patients went home after some days, but the drug reaction at Bhabha Hospital claimed the life of a 47 year old lady.
Says a senior Maharashtra FDA official, "FDA lab investigated the samples for carrying several tests including microbiology and sterility tests. Over 50, 000 samples were distributed to 14 hospitals across the city and no such drug reaction has been reported. The incidents of adverse drug reaction were reported only in the female ward of the civic run Bhabha Hospital. Drugs are of standard quality and may be considered safe for use."
Meanwhile, experts continue to debate the drug reactions and say that ceftriaxone and cefotaxime are not known to cause serious reactions. Adverse drug reactions are known to occur frequently in females but such an observation has not been reported as yet with this group of drugs.
Based on the scientific literature available, experts also advocate that the drug injected should be checked for degradation and 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.
Cefotaxime which is used to treat bacterial infections was the common drug to be tested and drugs used were from separate batches at both hospitals. The Bhiwandi incident saw only children getting affected, whereas at Bhabha and Rajawadi, women suffered adverse effects.
FDA officials had 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 completion of investigation. Cefotaxime injection is currently being manufactured under the brand name, Sanocef, by Sanjivini Parenteral Drugs, Navi Mumbai.