A prescription morning sickness medication is back on the market for the first time in 30 years, but the honeymoon phase is already over. A letter sent to healthcare providers promoting the drug has captured unwanted attention, and triggered an untitled letter from the Office of Prescription Drug Promotion (OPDP).
The November letter to drug maker Duchesnay, which runs about two-and-three-quarter pages (not including signature lines) is far longer than the promotional item in question, which runs under 200 words (not including greeting and sign-off), a comparison that somewhat amplifies what OPDP finds lacking.
Among regulator’s issues with the letter that mentioned the drug’s mid-May launch: omission of all risk information associated with the prescription medication that is intended to alleviate pregnancy-related nausea and vomiting. OPDP wrote that failing to include this information in the letter “misleadingly suggests that Diclegis is safer than has been demonstrated.”
OPDP also takes the company to task over the failure to include the full FDA-approved product labeling, as well as providing only the brand name, Diclegis, and not the established name, doxylamine succinate and pyridoxine hydrochloride, as required.