When the Food and Drug Administration investigates a pharmaceutical product, they may determine that the drug carries extraordinary risks. In instances when the problem comes from non-compliance or some similar error on the manufacturer's behalf, the agency will issue a warning letter. When the drug's ingredients pose a significant risk to a patient, but may still yield positive results if carefully monitored, the agency uses a different warning system. In the most extreme cases, this can include the FDA's black box warning.
Named for the thick black border around the label, a black box warning is the FDA's strongest warning sign for both patients and doctors. When this label is applied, the manufacturers are supposed to release a risk evaluation and mitigation strategy, or REMS, to more clearly address possible health risks. Additionally, the warning is meant to be a clearly visible sign to both physicians and patients to have a serious conversation about the potential risks involved in taking the medication.
Lawyer Malpractice
Unfortunately, this does not always happen. In some instances, the warning label may not receive a significant amount of attention from a physician. As a result, the patient does not head into the treatment process with a sufficient understanding of what kind of side effects that could be experienced. Additionally, if a doctor wrongly prescribes these medications, the results can be catastrophic.
Especially with black box medications, malpractice can be a life-threatening problem. To learn more about the kind of legal recourse available to injured or suffering patients prescribed a dangerous treatment, contact a medical malpractice lawyer.
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If you have suffered because of a healthcare professional's mistreatment, contact the Philadelphia medical malpractice attorneys of Lowenthal & Abrams, P.C., today.
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