![]() ![]() These over-the-counter monographs are like "a recipe book, covering acceptable ingredients, doses, formulations and labeling," she said. "I can't speculate as to whether this will result in changes to the label," Yao said, while explaining that the FDA regulates over-the-counter products through drug monographs. The agency noted that they represent only a small fraction of total consumer usage of these products. FDA scientists uncovered these cases during safety surveillance. There were 43 cases reported - from 1969 to 2011 - to the FDA of burns linked to over-the-counter topical muscle and joint pain relievers containing the active ingredients menthol, methyl salicylate and capsaicin. It depends on the FDA Adverse Event Reporting System, other databases and medical literature. Relying on a variety of sources, the agency will research a concern as far back as necessary. "The FDA plays an important role in ensuring products are safe and effective throughout their life cycle, and we continuously monitor for any adverse events," spokeswoman Stephanie Yao said. It is common for the FDA to issue safety warnings to alert consumers and health professionals, so they can make informed decisions about product usage. Some people were hospitalized because of serious complications. In many instances, the burns surfaced after only one application, and severe burning or blistering ensued within 24 hours, according to FDA Consumer Health Information. These topical pain relievers include creams, lotions, ointments and patches. While such injuries are rare, consumer complaints to the FDA have spanned the spectrum from mild to severe chemical burns from the use of brand-name products such as those identified by the FDA as Bengay, Capzasin, Flexall, Icy Hot and Mentholatum. Food and Drug Administration warned today. ![]() Tiger balm patch vs salonpas skin#Some consumers have contracted serious skin burns after applying certain over-the-counter topical pain relievers to ease mild muscle and joint aches, the U.S. ![]()
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