If the FDA approves a medication that later is shown to have severe side effects, is that a sign that the FDA was careless in their duty?
There is no such thing as a medication with no possible side effects. Drugs are chemicals, after all, and even the most seemingly innocuous chemicals can be dangerous when used inappropriately. When deciding whether or not to approve a new drug or medical device, FDA must weigh the known risks of the products against their effectiveness. And, often, FDA approves new treatments knowing that, even the recommended use can pose a risk of health problems, such as toxicity. When the agency does so, these risks are typically included on the product’s label, so doctors can be made aware of them and can monitor patients for possible complications. In other cases, previously unknown health risks appear only after a drug or device is approved for commercial use. Even when a product is subjected to very large clinical trials, the drug or device is tested on only a few thousand patients. When such treatments are then used commercially in patient populations totaling in the millions, some previously
