FDA Labeling Changes Often Come too Late
The FDA tracks “adverse events” related to drugs in its Adverse Event Reporting System (AERS). Potential safety issues revealed in this manner may lead the agency’s Center for Drug Evaluation and Research (CDER) to require the manufacturer to make changes in the drug’s labeling in one or more places: boxed warnings, contraindications, precautions, adverse reactions, and patient package insert/medication guide.
While the FDA at least attempts to keep up with newly emerging risks, harm has usually been done by the time the problem is discovered. Is it too much to ask for medications to be proven safe before they are prescribed and sold?
If you believe you have been harmed by an unsafe drug, contact Hodes Milman Liebeck for a free case evaluation. We’re aggressive personal injury and medical malpractice lawyers based in Los Angeles, serving all of California. We have the experience to take on the legal teams of pharmaceutical companies and have achieved multi-million dollar verdicts for our clients. Call us toll-free at 866-730-1976 or submit the contact form via our website, www.hodesmilman.com.