The US FDA published a list of 20 drugs last week which are found to have potential safety issues. The aim is to alert the public who are using these drugs for various health problems. Some of the widely used drugs listed are heparin, natalizumab, extraneal, Insulin U-500 and duloxetine. Such information is being published each quarter detailing drugs that have been identified as having potential safety issues based on reports in the FDA's Adverse Event Reporting System (AERS). FDA reviewers select the drug products based on millions of adverse events that are reported to the Agency by drug manufacturers, healthcare professionals and patients. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. The listing of a drug by FDA and a potential safety issue does not mean that the Agency is suggesting prescribers not to prescribe the drug or those patients taking the drug should stop taking the medication. New rules requiring publication of potential safety risks have been brought in September last year in the context of growing number of drug failures in the US market. It is possible that FDA, after further evaluation of the drug for the associated risk, may take follow up actions including requiring changes to the labeling of the drug, development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
Such regulatory practices are necessary for effective monitoring of drugs even after they are allowed for marketing. Pharmaceutical companies normally do not carry out Phase IV studies even though such studies are mandatory in several countries including India. ADRs of a new drug are fully known only after it is launched in the market and when several thousands of patients start using it. Tracking these reactions and compiling them are very critical to assess the safety and efficacy of the new drug. And that has to be done on a scientific and systematic manner. Establishment of Drug Information Centres in India by the state pharmacy councils since 2003 was to help pharmacists, doctors and patients to get focused information of a drug. To a great extend, these DICs help doctors in monitoring ADRs. But, a much committed and coordinated initiative is required to track unsafe drugs moving in the market. It is a fact that National Pharmacovigilance Advisory Committee was set up in 2004 with the objective of building a comprehensive pharmacovigilance data system in the country. After four years, NPAC is yet to generate credible data of ADRs of new drugs introduced in the market. This is a matter of serious concern considering the fact several new drugs are being approved by the office of DCGI every year. The Union health ministry should provide sufficient funding and manpower to carry out critical task of NPAC.