Healthy Skepticism Library item: 14284

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

Silverman E.
FDA Warns Forest Labs Over Bystolic Ads
Pharmalot 2008 Sep 9
http://www.pharmalot.com/2008/09/fda-warns-forest-labs-over-bystolic-ads/

Notes:

Link to warning letter:
http://www.fda.gov/cder/warn/2008/Bystolic-wl.pdf
Link to promotional material:
http://www.fda.gov/CDER/warn/2008/Bystolic-Promo.pdf

Full text:

The FDA sent a warning letter last month to the drugmaker for promoting its Bystolic high blood pressure med to docs without properly noting the medication’s risk. An 8-page ad, which ran in various medical journals, also implied the drug is better than rival meds even though there is no substantial evidence to prove such claims.
“Although the journal ad does include important safety information on its second page, it omits and minimizes certain risks,” wrote Thomas Abrams, head of the FDA’s Division of Drug Marketing, Advertising and Communications in the August 28 letter, which noted the ad specifically left off a warning about the drug’s use in patients with congestive heart failure.
The FDA also noted the ad claimed that the beta-blocker works better for patients who are obese, diabetic or have poor metabolism, even though clinical trials were not designed to show such an effect. Bystolic, approved in December 2007, has been linked to a number of serious risks such as cardiac failure and chest pain, according to the letter, and is not supposed to be used in a variety of patients, including those with various heart problems.
Frank Perier, Forest’s senior vp for finance and chief financial officer, tells Reuters the ad had been running in a variety of professional medical journals since January but was no longer in use.