it gives greater prominence to information about the effectiveness of the drug than to its side effects. Efficacy information is presented in large, colorful letters while risk information is presented in a small, black font.
The brochure omits some common adverse reactions experienced with the drug, the FDA said. Though the brochure discloses that cardiovascular events may occur, it does not disclose such side effects as injection site pain, post-procedural pain, and headache.
In addition, the brochure misleadingly implies the drug is approved for children as young as 4 when in fact it is not approved for children under 6, according to the FDA letter, which was posted to the agency’s website Feb. 2.
The brochure overstates the efficacy of phentolamine mesylate by claiming the drug will increase patients’ “comfort” and help them “return to normal,” the FDA wrote. The agency said there was no evidence for these claims. In fact, the FDA said, the drug may have the opposite result.
Side effects from phentolamine mesylate “may prevent a patient from feeling comfortable” and “may also prevent a patient’s return to normal,” the agency wrote.