Posts Tagged ‘remedies’

Over The Counter Remedies

Saturday, November 10th, 2012

By Robert A. Schwartz

Managing Attorney, Pharmaceutical Litigation

Robert A. Schwartz - Managing Attorney, Pharmaceutical Litigation

Over-the-counter (OTC) or nonprescription drugs are those that are deemed to be “safe and effective” for use without treatment or prescription by a doctor. There are over 300,000 OTC drugs. Since it is not required that the Food and Drug Administration (FDA) approve over-the-counter drugs, the manufacturer only has to make sure the drug’s labeling is consistent with the established, standardized format for the OTC drug labeling. The FDA does monitor the labeling for compliance. So, without a mandatory, pre-approval process to determine if the product is, in fact, safe and effective, the FDA can only monitor reports of adverse events related to OTCs.

On September 13, 2012, the FDA alerted the public about reports it had received regarding serious burns caused by topical (applied to the skin’s surface) muscle and joint pain relievers. In this particular instance, the FDA records showed 43 reports of such cases. Typically, these items take the form of creams, lotions, ointments and patches, and are marketed under brand names such as Bengay, Flexall, Icy Hot and Mentholatum. The majority of second- and third-degree burns occurred with the use of products containing menthol as the single active ingredient and products containing both menthol and methyl salicylate, in concentrations greater than 3 percent menthol and 10 percent methyl salicylate.

Skin reactions such as those that made the basis of the FDA’s September 13, 2012, action can be so serious that they require hospitalization. The two main injuries are Stevens-Johnson Syndrome (SJS) and Topical Epidermal Necrolysis (TEN), and they are no different from and require the same medical treatment as any other second- and third-degree burns. The injuries and treatments are extremely painful, and usually the injury will result in scarring on the affected areas.

If you have been diagnosed with a Stevens-Johnson Syndrome or Topical Epidermal Necrolysis injury from over-the-counter drugs such as Bengay, Flexall, Icy Hot or Mentholatum, you may be entitled to compensation. Call Bailey & Galyento discuss your legal rights and potential claim.