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FDA Issues a Warning to Makers of Suprenza

FDA Issues a Warning to Makers of Suprenza

The weight loss products industry generates $20 billion every year, according to a report by ABC News. With so many weight loss pharmaceuticals on the market, the Food and Drug Administration (FDA) keeps a close eye on manufacturers who make specific claims about the effectiveness and safety of their products.

In June, the FDA issued a strongly-worded warning letter to two companies responsible for manufacturing and marketing a weight loss drug called Suprenza. The manufacturer, Citius Pharmaceuticals, and the company in charge of marketing the drug, Akrimax Pharmaceuticals, were both reprimanded for failing to include any risk or contraindication information about the drug. The FDA also instructed the companies to remove language referencing the word “lean” from the Suprenza website, as there is no evidence to support the claim or inference that using the drug can make an individual leaner.

Although the manufacturer included a link to “prescribing information” on the Suprenza website, the site itself failed to mention any of the known side effects associated with the drug. Specifically, the FDA letter stated: “The webpage includes numerous efficacy claims and presentations for Suprenza; however, it omits all of the contraindications and adverse reactions associated with its use… By omitting serious and frequently occurring risks associated with Suprenza, the webpage misleadingly suggests that Suprenza is safer than has been demonstrated.” The FDA bolded the word “all” in its letter, obviously stressing the seriousness of the omission.

The exclusion is especially egregious in light of Suprenza’s link to the notorious diet drug, fen-phen, which was pulled from the market in the early 2000s after it resulted in serious illness and death in users who suffered dangerous heart and lung damage. Suprenza is the commercial name for the drug phentermine, which is one-half of the fen-phen combination.