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Off-label use of letrozole suspected behind a death, Kerala Health dept orders inquiry
P.B.Jayakumar, Chennai | Saturday, June 5, 2004, 08:00 Hrs  [IST]

The vigilance wing of the Kerala Health Department is conducting an enquiry into the circumstances that led to the death of a woman who was allegedly undergone treatment with the controversial cancer drug letrozole at an infertility clinic near Thiuvananthapuram, it is learnt.

The enquiry follows a police complaint filed by her husband against the clinic and its doctors for medical negligence, and a subsequent directive to the government a few weeks ago by the Chief Judicial Magistrate, Thiruvananthapuram, to probe the issue by a panel of experts. An enquiry team led by an additional director has already started investigation.

According to sources, one 28-year-old Sindhu, a high school teacher, died at an infertility clinic at Pattoor near Thiruvananthapuram during December last year due to cardiac arrest as per the medical records. At the time of her death, she was administered with an injection for anesthesia, as part of a laparoscopic procedure related to the treatment.

According to a complaint lodged by her husband Davidson, an assistant engineer with the State Electricity Board, the doctors at the clinic had prescribed Letrozole to his wife as part of the infertility treatment process, with a dosage of 5 mg tablets every day for inducing ovulation.

This act indicates the doctors were using a drug illegally in the treatment process as Letrozole had been banned in infertility treatment by the drug controller general of India. Hence the authorities should take action against the doctors, her husband demanded.

Sources said the couple undertook treatment with the clinic during November and December, last year. The doctors had prescribed many expensive tests and medicines to the tune of over Rs 5000 per month, including Letrozole.

Davidson maintained that his wife was killed due to medical negligence. An ECG taken a few weeks before the death vouchsafes his wife lacked any complications related to heart, and her overall health was very good. The clinic lacked adequate infrastructure and experienced paramedics to handle emergency situations that could creep up as part of surgical procedures, said the complainant.

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