Black box warnings on prescription drugs are very important. Actually, all warnings are important, but particularly black box warnings. Black box warnings are warnings on the promotional materials for a drug and on the medication guide. They are contained in a black box.
Black box warnings are issued only if a drug could have a serious or deadly adverse reaction, and someone using the drug has had such a reaction in the past. Normally, the deadly reactions were reported to the FDA after the drug was approved. Black box warnings are the FDA’s most serious warning, and normally it is the last step before a drug is recalled.
In order for the FDA to put a black box warning on a drug, there are a few criteria that are considered, including: if the drug must be administered in a certain way, if the drug must be administered by a doctor or in a medical setting, if the risk of the drug may outweigh its benefits, if early knowledge of a side effect would allow doctors to monitor the drug to prevent negative reactions, and if certain patients are at a higher risk for a serious or deadly side effect.
If you have been harmed by a prescription drug, you have legal rights. You may be able to hold the drug’s manufacturer accountable for your injuries or the doctor who prescribed it. Call me, Conal Doyle, Los Angeles personal injury attorney at 310-385-0567. My team may be able to help you obtain compensation for your injuries. Call today to learn more or to schedule a free consultation on your case.