Drug Companies worldwide have defined programs to collect reports of side effects and potential hazards of marketed preparations even after the drug is approved by FDA and launched. This helps the Regulatory Agencies and the Drug company to evaluate the risk:benefit profile of drugs in the market. Sometimes, compelling evidence can make the manufacturer withdraw the drug from the market or at least introduce contra-indications to prevent usage by certain high-risk group patients. This is called “Pharmacovigilance”.
|