Healthy Skepticism Library item: 17646

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Voltaren Gel is misleading?
Pharmacy Daily 2010 Apr 19
www.pharmacydaily.com

Full text:

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.