The Federal Drug Administration (FDA) regulates prescription drugs. This responsibility includes approving the warnings included with prescription drugs so that doctors and patients know the risks associated with that drug.
FDA Black Box Warnings are Serious
The FDA has different levels of warnings that must be included with prescription drugs. The most serious warnings are called black box warnings. The FDA requires a black box warning when a drug potentially has serious or life-threatening side effects. It is the final step before the FDA pulls the drug from the market. A pharmaceutical company that is required to include a black box warning on a specific drug is also required to develop a medication guide for that drug to provide more details about the risks for doctors and patients.
In recent years the number of FDA black box warnings has increased. Often, black box warnings are issued after people have experienced serious or fatal side effects, because only limited clinical testing is required before a drug gains FDA approval. It isn’t until after a larger population has used the FDA-approved drug that the true dangers are recognized.
When the FDA requires a black box warning for a drug, the manufacturer can still be held accountable for injuries caused by that drug. The warning is not a legal shield for the pharmaceutical company.
Call a Milwaukee Pharmaceutical Injury Lawyer If You’ve Been Injured
If you have suffered the serious side effect of a prescription drug, then it is important to contact an experienced Milwaukee class action attorney today to discuss your rights and possible recovery. You can reach our attorneys by using the contact form on this website or calling us directly at 1-800-800-5678 or 414-223-4800.