Pharmacy Daily | Voltaren Gel is misleading?

THE US Food and Drug Administration has issued a warning letter to Novartis Consumer Health, regarding what it sees as “false or misleading” direct-to-consumer Voltaren Gel information. According to the FDA, Novartis’ direct-to-consumer Voltaren Gel promotional materials breached several statutes in the US Food and Drug Act, by overstating the product’s efficacy and also by minimising “serious risks” associated with Voltaren’s usage. The direct to consumer email in question claimed that Voltaren Gel “[keeps] joint pain from interrupting your days ahead” and “[keeps you] living life with less painful interruptions”. The FDA took umbrage at the claims, saying they imply that Voltaren Gel has been proven to have a “direct, positive, and broad impact on a patient’s activities of daily living by reducing or eliminating daily interruptions due to joint pain”. The “FDA is not aware of substantial evidence or substantial clinical experience demonstrating that using Voltaren Gel results in an overall positive impact on the general activities of daily living as suggested,” the agency said. The FDA also found Novartis’ claims that Voltaren provides “targeted relief” were misleading because it suggested that Voltaren may be useful on any type of joint pain, whereas in fact it has only been FDA indicated for “relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands”. Novartis also received a warning over the minimisation of usage risks because the risks were presented “in extremely small black font, and in [difficult to read] single-spaced paragraph format” and in “complex medical terminology”. The FDA has now ordered Novartis to cease the distribution of all of the offending promotional materials, and has also requested a written response as to whether the company will comply, and exactly which other promotional materials contain the same “misleading” and “false” information.

---

The above article was sent to subscribers in Pharmacy Daily's issue from 19 Apr 10
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 19 Apr 10