FDA Nagpur recalls 158 vials of Amphotericin B emulsion as patients suffer reactions

NAGPUR: The food and drugs administration (FDA), Nagpur, has called back 158 vials of Health Biotech Limited’s anti-fungal drug Amphotericin B emulsion, used for treating mucormycosis, after several patients reportedly developed reactions. One patient suffered a cardiac problem, requiring him to be shifted to intensive care unit (ICU), said doctors.
Sources in the FDA stated that around 200 vials of the drug had been distributed in Nagpur district some days back.Of these, 42 had been used on patients. FDA then received information of several patients developing reactions at different hospitals on use of this batch. FDA then stopped sale, distribution and use of the rest of the stock of the injections of batch number HIVP2103 till the report of the government analyst from the Drugs Control Laboratory is received.
Assistant commissioner of FDA (in-charge) PM Ballal said drug inspector Lohkare has collected samples from 28 vials of Health Biotech’s Amphotericin B emulsion, which were sent to the laboratory for checking, but the stock has been called back from hospitals until the government analysis report is received.
Ear, nose and throat (ENT) surgeon Dr Samir Choudhari of Neuron Hospital narrated the scary incident of how a patient nearly collapsed due to cardiac complications after taking Health Biotech’s Ambibio -E (Amphotericin B emulsion) injection but was saved by his team. “This particular injection was brought by the patient’s relative from outside the hospital. The patient had to be salvaged with some quick efforts after he slipped into cardiac complications immediately,” he said.
ENT surgeon, and also secretary of the Association of Otolaryngologist of India, Vidarbha branch, Dr Samir Thakare said he had received information from various sources regarding reactions suffered by patients after being administered the emulsion. “There is information regarding Amphotericin B emulsion injection procured from outside hospitals triggering reactions. Apart from heart problems, anaphylaxis conditions or allergic reactions too developed in some patients taking the lupid emulsion,” he said.
Thakare said Amphotericin B Lupid emulsions without filter can cause such reactions if there is particulate material left behind in it.
ENT surgeon Dr Prashant Kothalkar of Seven Star Hospital said he had some patients who came back from their home town outside Nagpur with reactions after taking Amphotericin B emulsions.
Commenting generally, Dr Kothalkar said mucormycosis is a ‘medical disease’, which requires team effort to manage the complications. “Treatment with Amphotericin requires lot of care and teamwork as it can lower potassium, sodium and magnesium, and also induce kidney and liver complications which must be attended and tackled simultaneously,” he said.
ENT surgeon Dr Swata Lohiya said a couple of patients had developed complications and reactions like fever and chill after being administered Lupid emulsion, after which her hospital decided to send back the entire stock. “These kinds of reactions happen when one of the ingredients in the drugs is not fit for use,” she said, adding some patients are prone to develop reactions while some tolerate drugs in a better way.
Dr Lohiya suggested using drugs of same brands and companies be administered to patients rather than changing them frequently for whatever reason.
Dr Choudhari also said, “Generally, these anti-fungal drugs require proper storage, the cold chain has to be maintained with ice boxes and such precautions are required to be taken otherwise there are chances of reactions, reduced efficacy and so on.”
BOX
DRUG REACTION
200 vials of Health Biotech Limited’s anti-fungal drug Amphotericin B emulsion distributed around Nagpur some days back
Mucormycosis patients had been given 42 vials of the drug, and some developed reactions, with one suffering cardiac problem
On receiving information, FDA stopped sale, distribution and use of the rest of the stock of injections of batch number HIVP2103
28 samples sent for analysis at Drugs Control Laboratory