Drug Companies Warned Against Compounding of Topical Ointments

In December 2006, the Food and Drug Administration warned several U.S. pharmaceutical companies against “compounding” or altering topical ointments used for a variety of purposes. These companies all produced similar anesthetic ointments using medications such as lidocaine, commonly used to treat premature ejaculation ( PE ). Each company was warned to stop compounding these ointments.

Some of the side effects of overly high concentrations of medications like lidocaine are seizures and cardiac arrhythmias. While compounding is not against the law, the FDA is concerned that compounding medications like lidocaine, benzocaine, prilocaine, and tetracaine, among others could be hazardous to public health.

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