FDA Warns Two Pharma Companies Over Misleading Ads

Posted 16 December 2016 | By Zachary Brennan 

FDA Warns Two Pharma Companies Over Misleading Ads

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent two warning letters earlier this week for misleading advertisements.

One of the warnings was sent to Salt Lake City-based Spiraso due to “false or misleading claims and/or representations about the risks associated with Tuxarin ER” on the company’s website. Tuxarin is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years and older.

Claims on the website “are misleading because they suggest that Tuxarin ER is safer than its competitors based on differences in dosage formulations and the safety profiles of individual ingredients,” FDA said. “No references were cited in support of these claims and we are not aware of evidence to support the suggestion that Tuxarin ER is safer than its competitors because of its tablet formulation or because it is not associated with 'dosing errors' or 'serious safety issues.'"

The other letter was sent to Hauppauge, NY-based United-Guardian over an email that makes false or misleading claims about the risks and benefits associated with Renacidin, which is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures.

“The e-mail contains multiple claims and/or representations about Renacidin; however, it fails to communicate any risk information. We note the statement, 'CLICK HERE for complete prescribing information[,]' is included in the e-mail. However, this statement does not mitigate the omission of the risk information from the e-mail,” FDA said.

Earlier this week, OPDP also sent untitled letters to Celgene and Sanofi-aventis due to their misleading television commercials.

Spiraso, Warning Letter (PDF) and Promotional Material(PDF)

United-Guardian, Warning Letter (PDF) and Promotional Material(PDF)

Categories: Regulatory News

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