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FDA Warns Drug Maker Over Misleading Ads

Wednesday September 17, 2008

The US Food and Drug Administration (FDA) on Tuesday sent a stern warning to drug maker Forest Laboratories about claims raised in advertisements for one of Forest's high blood pressure medications. An eight page ad for the drug Bystolic (nebivolol) claims that the drug is superior to other high blood pressure treatments and that it works in a novel way to combat the problems of high blood pressure.

The FDA disagrees, saying that there have never been any studies comparing Bystolic to other, similar, medicines, and that the claims made in Forest's advertisements cannot be substantiated with evidence.

On the FDA website Tuesday, a spokesperson commented that Forest's claims were dangerous to the public because they suggest "that Bystolic is safer and more effective" than it actually is.

Nebivolol is a type of beta blocker, one the most commonly prescribed medicines for the treatment of high blood pressure and heart disease.

Comments

September 22, 2008 at 4:32 pm
(1) dan says:

Dear Dr. Weber,

While reviewing blogs that discuss health related topics, I noticed that yours seems to be well-read and well-informed. Your readers may be interested in the redesigned healthfinder.gov. The site offers quick and easy prevention information and tools to help people stay healthy and prevent disease.

Healthfinder.gov’s new Quick Guide to Healthy Living uses everyday language and examples to:
• Describe “small steps” users can do to improve their health
• Give users positive reasons to change their behavior
• Provide tools and encouragement, such as personal health calculators, menu planners and recipes, tips for caregivers, and printable lists of questions to take to the doctor

The new “myhealthfinder” tool gives users personalized health recommendations based on sex, age, and pregnancy status, from the U.S. Preventive Services Task Force.

The redesign of healthfinder.gov was informed by health literacy and usability principles, and the site was tested with more than 650 users. We’re excited about the result – a consumer health Web site that’s easy to understand and navigate, especially for people with limited health literacy.

The healthfinder.gov project is coordinated by the U.S. Department of Health and Human Services’ Office of Disease Prevention and Health Promotion (ODPHP) and its National Health Information Center. Thanks for helping us spread the word.

Regards,
Dan Jeffers
Internet Marketing Specialist for
Office of Disease Prevention and Health Promotion

September 23, 2008 at 9:22 am
(2) Sam says:

Seems that the Government is part of the problem by allowing the drug companies to advertise. Most,if not all,other countries do not allow this.

Even if the ads were factual, most lay folks would not understand the various aspects of each drug. It’s our Government at work. Kinda like the self serving do not call program.

There are other ways to gain insight.

October 6, 2008 at 8:27 pm
(3) Maddyb says:

Doc
Im on Tekturna, have been for 3 weeks. 150mg
My bp has gone UP! The point was to get it down. I took Benicar and Benicar hct both at different times, the Benicar worked for awhile, but stopped, my doc put me on benicar hct, and it worked TO well, and my sodium levels were extremely low, and my bp was 74/54.
He took me off everything, for two weeks and bp began to climb back up, got to 160/90 so he put me on tekturna. I dont know much about it, but Ive had diarreha since I started, and my bp hasnt gone down, it was 180/90 today.

I really need to know how to drop my systolic pressure, it gets so high, any suggestions??

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