• Regulatory NewsRegulatory News

    Public Citizen Sues FDA Over OTC Drug Risks

    Nonprofit Public Citizen on Thursday sued the US Food and Drug Administration (FDA) alleging that the agency has failed to act on safety issues related to the over-the-counter (OTC) drug benzocaine. The lawsuit, filed on the grounds that FDA is in violation of the Administrative Procedures Act for "withholding or unreasonably delaying action" on a citizen petition filed by Public Citizen in 2014 that calls on the agency to add a warning that benzocaine can cause ...
  • Regulatory NewsRegulatory News

    FDA Recommends Against Use of Painkillers for Teething Pain

    US Food and Drug Administration (FDA) regulators are warning that young children who are teething and experiencing pain should not be given lidocaine, a topical painkiller, due to the serious and even fatal risks associated with the drug. In a 26 June announcement , FDA said that the application of oral viscous lidocaine 2% solution had been associated with at least 22 reports of serious adverse reactions, "including deaths," in young children and infants. At leas...