Are black box warnings for prescription drugs important?

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Yes, all warnings for prescription drugs are important, but especially black box warnings. Black box warnings are warnings contained in a black box around text on the medication guide as well as the promotional materials for a particular drug.

Drugs only receive the black box label in the event of a serious, usually deadly adverse reaction. The reaction was typically reported to the FDA after the drug was approved. Unfortunately, in some cases, the manufacturers of the drugs hid their knowledge of the side effects to hasten the drug’s approval process.

A black box warning is the FDA’s most serious warning. It is the normally the last thing that happens before a drug is recalled. There are a number of criteria that must be used to place a black box warning on a medication. They include: the risk of the drug may outweigh its benefits, the drug must be administered by a doctor or in a specific setting, the drug must be administered a certain way, certain patients are at a higher risk for a serious or deadly side effect, and early knowledge of a side effect would allow doctors to monitor to prevent reactions.

Black box warnings were introduced in 1979. Since 2004, adverse events have been reported through a program run by the FDA. The program allows consumers, professionals, healthcare providers, or others to report any side effect associated with a particular drug. Once an event is reported, the CDC reviews the incident, and may open an investigation. After the investigation, the FDA may require that a black box warning be added to a drug’s materials.

There are a number of commonly prescribed drugs that contain serious black box warnings. In many cases, these warnings are not properly communicated to the patient, or the patient is not properly monitored after taking the drug.

If you believe that you or a loved one was negatively affected by a prescription drug, you may have a legal case against the drug’s manufacturer or the doctor who prescribed it. Call the Houston personal injury attorneys at Kennedy Hodges at 855-947-0707 to learn more about your legal rights. We can help. Call today to schedule a free consultation on your case, or visit us on Twitter to learn more about the firm.

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