Using New Drugs – A Word of Caution!

Using New Drugs – A Word of Caution!

Dr Guruprasad Mohanta, Professor, Annamalai University.

We are all fascinated and obsessed with new things; and the drugs are not exceptional. But the new drugs are more likely to bring new surprises. The world still remembers the outcome of the use of the then new drug, thalidomide in 1960s. The innovator company promotes the drug aggressively and the new drugs are prescribed more often than is really needed.

Many drugs have been withdrawn from the market at different times after their introduction because of actual or perceived threat. One of the studies showed that one-third of the drugs withdrawn was within two years of launch and half were within five years. There are different expert opinion about the scope of using new drugs. One of the researchers advises not to use or avoid new drugs for three years, if possible. The researcher claims that that 22 of 528 new drugs Health Canada, Drug Regulatory Authority of Canada, approved between 1990 and 2010 were pulled out from the market. This accounts for 4.2 percent. Nineteen were pulled out because of specific safety concerns; two were pulled out because they caused harm more than the benefits. 11 drugs were withdrawn in less than three years of launching.

            Another group of researchers advises the seven years waiting period unless the new drugs are real therapeutic breakthrough.  548 new chemical entities (drugs marketed for the first time in the United States) were approved during 1975 and 1999. By 1999, 45 drugs (8.2%) acquired one or more black-box warnings and 16 (2.9%) were withdrawn from the market. Half of these black-box warning changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years.

            These studies justifies the safety concern of new drugs. In India, a drug is known as new drug till four years of its approval. Whether, it is three years or seven years, therapeutic need of the patients should be the primary concern. The pharmacopeia drugs are the best option. The Medical Care providers should play safe and should restrained from recommending new drugs unless there are real innovations in the new drugs or no other treatment options available. Let’s the patient safety be the priority in medicine use!