Drug to treat Mucormycosis no longer available in market, say Kerala hospitals

‘Amphotericin B’, the critical drug which does not have an alternative, is no longer available in the open market for purchase.
Health workers in PPE inside critical care unit
Health workers in PPE inside critical care unit
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As Kerala is starting to witness an increase in the number of people being infected by the deadly fungal infection Mucormycosis, also known as ‘black fungus’, there is an acute shortage of the vital drug that is used to treat the disease. According to various private hospitals in Kerala, the drug ‘Amphotericin B’, the critical drug which does not have parallels, is no longer available in the open market for purchase.

Mucormycosis or ‘black fungus’ is caused by mucormycetes molds, affecting the central nervous system, eyes, sinuses, lungs etc. The disease which has been largely found to affect immunocompromised persons, people with diabetes (especially with ketoacidosis) etc., can result in death. The non-contagious infection rapidly spreads in the body affecting critical organs. Kerala has officially reported at least six deaths following the second wave of COVID-19 pandemic.

According to experts, the disease is being treated by an intravenous drug named Amphotericin B and is the only effective one to treat critically ill patients affected by Mucormycosis. Since the cases of Mucormycosis used to be rarely reported before, considerable stock of medicine was not available in the state, hospitals say. But now with increasing cases in Kerala as well as in other states, there is an acute shortage of the drug.

“Situation is really pathetic. If more patients come seeking treatment, we may not even be able to admit them. There is no shortage, the drug is not at all available in the market at present,” an official of a private hospital in Ernakulam district told TNM.

According to experts, not more than 20 Mucormycosis cases are expected in the state normally in a year. “Therefore the availability of the medicine stock has also been less. But now, even if there is demand, the drug is not available. Though there are Indian companies which produce the drug, prime raw materials which go into making of the drug comes from abroad from countries like China. So there is a difficulty,” says a medical expert.

Considering the lack of availability of medicine, the increase in the number of cases are also alarming, doctors state. “In our hospital alone, from the first week of April to May first week, six patients sought treatment. This was even prior to when the state government started tracking the disease,” said another private hospital official in Kerala.

According to experts, the drug Amphotericin B comes in three formulations -- liposomal, conventional and lipid complex. Among the three, liposomal Amphotericin B is widely used. “It is the most safe to use. But it is expensive, one vial measuring 50 ml costs from Rs 5,400 to Rs 8,000. On an average, a patient will require 5 milligram per kg daily. So on an average, during the course of treatment, a patient might need 60 mg per kg and it will cost around Rs 40,000 as the MRP of the drug alone,” says Dr Vineeth Viswam, senior consultant ENT surgeon of Aster Medicity in Kochi.

“Lipid complex amphotericin B costs Rs 3,000 to Rs 4,000 is also comparatively safe to use, but the conventional amphotericin cannot be tolerated by most people and they can injure kidneys,” he adds.

Dr Vineeth also adds that the administration of amphotericin can affect kidneys and fluctuate sodium-potassium levels in blood. “Therefore it is also very crucial that the drug is only administered while the patient is hospitalised,” he adds.

Though there are two other drugs -- Posaconazole and Isoconazole -- which are administered as tablets, they are not effective in critical patients. But even these drugs have a shortage in the state.

“There is not other alternative for Amphotericin B. Only once the patient’s condition improves, we can administer drugs like posaconazole and isoconazole,” says Dr Sujith Nayanar, senior Ophthalmologist of Aster MIMS in Kozhikode.

Meanwhile, due to the acute shortage, the state government has centralised the management of the available stock of amphotericin in various hospitals. As per the specific requirement of the patient, the government is distributing the existing stock from hospitals to wherever it is needed. Though this is seen as a positive intervention by the government, medical experts raise concern on how much long this could be continued.


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