The US FDA last week issued a public health advisory recommending not to use cough and cold products including decongestants, expectorants, antihistamines, and cough suppressants for the treatment of these indications in infants less than two years of age. Despite serious concerns expressed by medical experts over the use of cough and cold products in the past, parents continue to give various brands of cough and cold remedies to their children in the US. These preparations are found to be treating only symptoms and not the underlying conditions. There are a wide variety of serious adverse events also reported with the use of cough and cold products including death, convulsions, rapid heart rates, and decreased levels of consciousness, according to US FDA. Some of the major pharma companies like Wyeth and Johnson & Johnson have already withdrawn their cough and cold products voluntarily from the market in October last year. But several other brands continue to remain in the market. Last week's FDA advisory is only a first step in its drive against unsafe pediatric medicines in the US. It will be making a final recommendation about use of cough and cold medicines in children aged between 2 and 11 years after the review of medical data for children in this age group is completed. And that should be happening very soon.
The action took by US FDA should be an eye opener to the Central drug control authority in India where hundreds of cough and cold preparations are being marketed without any therapeutic scrutiny for several decades now. Some of the brands like Benadryl, Corex and Phensydyl are probably top selling pharmaceutical products having nearly Rs 100 crores or more in annual sales. It is true that almost all these products are licensed for manufacture by the state drug authorities and not the office of DCGI. And they may not be as dangerous as some of the drugs which are either banned or withdrawn now from the world markets such as cisapride, nimesulide, rofecoxib, valdecoxib, etc. But, their ill effects on infants and children should not be under estimated. Several medical experts in India have gone on record in the past demanding a critical evaluation of all cough syrups and cold preparations marketed in the country. Usually they contain some sugar, honey and other non pharmaceutical ingredients which cannot cure cough or cold. As they are strongly promoted through physicians and pharmacies, pharmaceutical companies achieve huge sales and profits out of these products. In fact, in India a large number of cough and cold preparations also contain a banned substance, phenylpropanolamine (PPA). In the US, the use of PPA was banned as early as November 2000 amidst stiff opposition from multinational companies. Now, as a review of irrational drug combinations has been already launched in the country, the office of the DCGI should also scrutinize the entire spectrum of cough and cold preparations for their therapeutic rationale.