Black Box Warnings
The federal government relies on the Food and Drug Administration to monitor and regulate the pharmaceutical industry in the United States. As a part of the FDA’s efforts to keep dangerous products out of the hands of consumers, the agency uses different methods to deal with particularly hazardous medications. Of all of the possible warnings the FDA can issue, the black box warning remains the strongest possible warning.
To discuss your legal options if you have suffered harm due to a dangerous pharmaceutical product, contact the Philadelphia medical malpractice lawyers of Lowenthal & Abrams, P.C., today at 215-238-1130.
Warning Labels and Malpractice
When a pharmaceutical product receives a black box warning, the manufacturer of the medication and physicians prescribing the drug are asked to take sufficient action to reduce misuse. In particular, the FDA requires manufacturers to submit what is known as an REMS, or risk evaluation and mitigation strategy. In many cases, these strategies consist of additional drug literature or a separate warning packaged with the drug. On the physician’s behalf, failure to heed a black box warning may result in the following problems:
- Wrongly prescribing a life-threatening medication
- Failing to inform a patient of the potential risks
- Ignoring or not knowing the medication side effects
One of the most important parts of treatment is the relationship between the physician and the patient. If a doctor does not adequately describe a patient’s health problems and the available treatment options, the patient may not know to relay certain side effect symptoms.
Contact Us
When a physician does not properly handle drugs with such serious and visible warnings as a black box label, the consequences for the patient can prove devastating. For more information on your legal options if you or someone you love has suffered because of a doctor’s negligence involving a prescription drug, contact the Philadelphia medical malpractice attorneys of Lowenthal & Abrams, P.C., by calling 215-238-1130.