At a time of heightened concern over abuse and dependence issues surrounding medicines, the Food and Drug Administration slammed a small drug maker for sending an email to physicians that appeared to “intentionally” omit any mention that its insomnia pill is a controlled substance.
In a Sept. 13 warning letter sent to Galt Pharmaceuticals, the agency complained to the company that the email made numerous claims about the benefits of its Doral pill for treating insomnia. But the email completely failed to mention the warning and precaution language in the prescribing label about the withdrawal syndrome associated with benzodiazepines, such as Doral.
The FDA also noted that the email contained information comparing Doral with other insomnia salves, but did so in a way that minimized the risks of abuse and dependence, while also suggesting the pill is safer than other prescription or over-the-counter medicines. Doral is classified as a Schedule IV controlled substance, which means it has a low potential for abuse and a low risk of dependence.
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