Are Pharmaceutical Market Withdrawals Preventable? A Preliminary Analysis

Abstract

Some drugs have been removed from the market once it had been determined that their risks outweighed their benefits. Withdrawals negatively impact patients using the drugs as well the pharmaceutical companies who devoted tremendous resources to research, development, and marketing. Therefore, there is a desire to minimize drug withdrawals by learning from previous incidents. Hints of the problems that lead to eventual market withdrawal might be found in the initial New Drug Application (NDA). If inappropriate approvals could be prevented, patients’ safety might be protected and withdrawals would not be necessary. Drugs withdrawn between 2001 and 2010 (n = 15) were considered for this investigation. The primary adverse events that led to the withdrawal of these 15 drugs were compared with the data available in the original NDA medical review. From the 15 drugs considered, sufficient information for analysis was available for only 7 drugs. Among the 7 drugs analyzed, the safety data found for 2 particular drugs suggested potential safety signals. Preliminary analyses suggest that the drug withdrawals could not have been predicted for the majority of drugs removed from the market.