The trouble with new drugs

When a drug is approved by the FDA, it may seem like it’s only a matter of time before some unexpected side effects are discovered. Perhaps it seems that way because it’s true! According to a study of all drugs approved between 2001 and 2010, the FDA announced alerts, warnings, or recalls on about one-third of them in the years after their approval. Some of the side effects were minor and easily managed. For example, there might be a warning to avoid taking a new medication at the same time as another medication. But sometimes the “side effect” is death. And that’s the case with a new warning about the gout drug febuxostat. An ancient disease, new treatments, new concerns Gout can cause joint pain that’s excruciating and debilitating, but it is highly treatable and even preventable. In recent years, a number of new drugs have been approved, including febuxostat. Although it was approved in 2009, some of the early studies raised concerns that people who took febuxostat might have a higher rate of cardiovascular events such as heart attacks. As a result, the FDA required the drug’s maker to perform additional research after its approval. The additional research confirmed that the safety concerns were justified: when compared with people taking allopurinol, an older gout drug, researchers observed a small but significant increase in the rates of cardiovascular death, and death from all causes, among people taking febuxostat. This led the FDA to issue a “black box...
Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Drugs and Supplements Health Source Type: blogs