U.S. Food and Drug Administration Sends Warning Letter to Illegitimate Online Pharmacy
The U.S. Food and Drug Administration has sent a warning letter to an online pharmacy accused of selling controlled and unapproved substances in violation of the Federal Food, Drug and Cosmetic Act (FFDCA), according to a press release.
The pharmacy, Rx-promotion, reportedly operates nearly 300 internet domain names, through which it sells and dispenses medications with a prescription.
Among the drugs offered by Rx-promotion's sites is rimonabant, a medication intended to curb appetite. According to the letter, the drug failed to win approval from the FDA "because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness and suicidal thoughts." Sale of unapproved drugs constitutes a violation of the FFDCA.
Additionally, the sites sell isotretinoin, which was once commonly marketed in the United States as Accutane. Due to the medication's potentially dangerous side effects, medical practitioners and patients must register with a special FDA-operated program before being able to legally receive this medication. The letter states that "these safety controls are bypassed when this drug is purchased from foreign sources or over the internet, placing patients who use this drug at risk."