Off-label use of drugs on patients is a dangerous trend in medical practice perpetuated mainly at the instance of top pharmaceutical companies. Even in developed countries, checks and controls on such practice are either ineffective or go undetected. Terbutaline, a drug approved by US Food and Drug Administration for asthma treatment, is being widely prescribed to prevent premature labour in that country. It is very common amongst the doctors in the US to prescribe epilepsy drugs for treating depression, hot flashes and weight loss. A recent Knight Ridder investigation has found that eight out of 10 prescriptions for the epilepsy drug, Topamax, are not written for epilepsy. For patients with rare or fatal diseases with no known remedies available, off label prescribing can prove to be beneficial. Their number, however, is too insignificant. But there are thousands of victims of off- label drug use who have suffered heart attacks, strokes, permanent nerve damage and lost eyesight in recent years in the developed countries. Despite sharp rise in off label drug use, the drug control authorities including the US FDA have done little to prevent or discourage such a practice.
In most cases of off label use of drugs, it is the pharmaceutical companies, which are engaging the doctors to conduct such trials on unsuspecting patients. And the doctors are willing partners to this illegal practice for a suitable compensation. Patients are, usually, neither informed about such a trial being conducted on them nor briefed about the harmful effects of the experiment they are subjected to. This is precisely what has happened in the case of Letrozole in India a few months ago. Top companies like Sun Pharma, Dabur, Natco and Fourrts have been promoting this breast cancer drug through doctors for treating female infertility. Such promotion was in clear violation of the section 122-E(b) of the Drugs and Cosmetics Rules. DCGI granted marketing approvals to these companies for marketing the drug as a breast cancer therapy. But, only after Pharmabiz brought the off label promotion of this drug to the notice of the government, DCGI, had initiated action against these companies. The side effects of letrozole on patients are grave including ovarian tumours, liver cancer, hyperplasia of ovaries, etc. In another case of off label drug use, it was found that some medical practitioners in Rajasthan have been using Misoprostol, an anti-ulcer drug, for terminating pregnancy amongst illiterate women in that state. In this case, there is no involvement of any pharmaceutical company in the off label use of Misoprostol. It is possible that cases of off label uses of drugs could be rampant and cannot be detected easily in the vast semi urban and rural areas of the country. And that calls for a comprehensive monitoring system to check such illegal practice by the pharmaceutical companies and medical profession in the interest of public safety.