The US Food and Drug Administration (FDA) offers an online form for the voluntary reporting of severe adverse reactions (SARs) to FDA regulated drugs, medical devices, and other products. While advocacy groups are reporting that they’re seeing an increase in severe adverse reactions, such as SJS and TENs, from prescription and over the counter medications such as ibuprofen, the FDA indicates that they are not aware of any increase.
It is believed that significantly more severe adverse reactions occur in the United States each year than are reported to the FDA. The FDA indicates that it takes submissions to the MedWatch Online Voluntary Reporting Form into account when evaluating the number of severe adverse reactions.
SEG Law hopes that the FDA will require ibuprofen manufacturers to place warnings about the risk of SJS and TEN from using their products. We’re fighting in the courtroom to hold manufacturers of ibuprofen responsible for exposing consumers to this terrible risk without adequate warning.
Before you submit your SAR on the MedWatch form, contact us to discuss your Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis case – for free and without obligation. We’ll advise you on the legal implications of reporting your reaction.
You had a right to know the risks. Contact us today at 1-866-632-7574.
