More than a dozen kidney patients in Mumbai have reported severe infections and related complications, possibly from the use of contaminated dialysis solution made by a multinational drug firm.
Some 15 patients who used the solution between April and June this year developed peritonitis, an infection caused by faulty dialysis.
The company that manufactures the solution denied there was anything remotely wrong with the product. But, as a precaution, the firm ‘voluntarily’ recalled two batches of the solution, a company representative said in an email.
The infection among Mumbai patients was revealed in a research paper presented on August 16 by nephrologists Dr Vishwanath Billa, Dr Deepa Usulmarti and others, to 250 colleagues at the annual conference of the Peritoneal Dialysis Society of India at Pune.
Peritoneal dialysis (PD) is used to extract toxins from the blood that failed kidneys can no longer filter. Peritoneal infection, which can be life-threatening, can be bacterial, fungal, or chemical in origin.
According to Dr Billa, peritoneal dialysis is one of the two methods used by patients with kidney failure. “Infectious peritonitis arises out of faulty technique used by the patient for doing the dialysis, while chemical peritonitis is caused entirely by an error by the PD fluid manufacturer.”
Investigations by doctors treating the patients suggested that all the infected patients in Mumbai were using the PD solution with the same batch number. The paper said that a sample of the PD solution was put through tests at the Indian Institute of Technology (IIT) - Bombay, which showed that the particular batch was contaminated.
“The tests done at IIT established that there was undoubtedly extraneous matter in the solution,” said Dr Billa.
In its response, the manufacturer raised questions about the research paper findings. It said: “The result does not conclusively mention that there is evidence of chemical peritonitis. In fact, as per that report, additional investigation reports are awaited.”
Furthermore, the company maintained that in its own lab tests, the product did not reveal any contamination.
“Our quality teams, both in India and globally, has conducted an extensive investigation to identify the root cause leading to reported cases of peritonitis in Mumbai,” said the company’s spokesperson.
Dr Billa said four of the patients who developed the infection had to undergo a surgical procedure to remove the catheter that enables patients to carry out peritoneal dialysis at home.
Among the patients are 74-year-old Colaba resident Rajam Rajamani and 56-year-old Manvi Bose (name changed).
Rajamani, a retired media professional and academician, needs to undergo three sessions of dialysis a day, owing to her advanced kidney disease.
However, in June, she developed an infection for the first time. “The infection took a toll on my life. Apart from money spent on treating myself, the consequences on my physical and mental health were immense; all the more because of my age,” said Rajamani.
It was a spurt of cases like Rajamani’s that led to the suspicion that it may have been the solution used that was responsible. While Rajamani could manage with medication alone, Bose had to undergo a surgical procedure, hospitalisation and intensive medication to ward off the adverse effects of the infection she contracted.
As patients developed complications, the company is reported to have called users who were using the product in the last week of August, asking them to not use the PD solution with a particular batch number.
The company said it recalled two batches that were used by patients who developed peritonitis as a precaution.
Rajamani said she was called after she had already used one of the eight units of solution in a box. “I asked the company executive what was wrong with that particular batch. The person just said that it has leakage issues and I must not use the rest. They would replace the remaining seven units. But, when I asked what precaution I needed to take given that I’d already used one of the “leaked bags”, the executive brazenly said just don’t use the rest and you don’t need to do anything about what you’ve used,” Rajamani said.