Black Box Warnings
Of the many duties performed by the Food and Drug Administration (FDA), one of the most important is the regulation of pharmaceutical products. While pharmaceutical companies have benefitted society by creating medications that cure disease and improve individuals’ quality of life, they do occasionally make errors. Unfortunately, when errors are made in the pharmaceutical industry people can become incredibly ill and can even die.
The black box warning is the strongest warning label that the FDA has. It is reserved for drugs that may have very serious adverse effects. If you have been given a dangerous drug and you were not informed of its potential dangers, someone may have made a serious error in prescribing it. Call 610-667-7511 to speak with a Pennsylvania medical malpractice attorney at Lowenthal & Abrams, P.C., about your situation today.
Labels, Malpractice, and Pharmaceutical Errors
Manufacturers of a drug that receives a black box warning must take action, including submission of risk evaluation and mitigation strategy (REMS). A REMS consists of separate warnings and additional literature about the troubles associated with the drug. Furthermore, the black box is a signal to physicians to exercise extreme caution when prescribing this medication to patients. For medications with black box warnings, it is important that the benefits of the medication outweigh the possible damage of a bad side effect.
Examples of distributing these drugs inappropriately can include:
- Wrong Prescription – resulting in a patient receiving a black box drug unnecessarily
- Failure to Inform – not telling a patient he or she may experience damaging side effects
- Ignoring Side Effects – not heeding these warnings, which is reckless
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You need to be able to trust your physician, and if he or she betrays your trust by prescribing you a drug that could potentially cause severe or life-threatening damage to your health, they have violated the tenets of that relationship. If this has happened to you, remember that you have rights. Call 610-667-7511 to discuss your situation with the Pennsylvania medical malpractice lawyers at Lowenthal & Abrams, P.C., today.