US FDA warns Glaxo on hypertension drug

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Thu, 3 Feb 2005 21:52:16 -0500

[sSRI-Research] US FDA warns Glaxo on hypertension drug marketing

 

UPDATE 2-US FDA warns Glaxo on hypertension drug marketing

 

Thu Feb 3, 2005 06:09 PM ET

(Adds company reaction paragraph 5-6, updates shares)

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05-02-03_23-09-19_n03669154_newsml

 

WASHINGTON, Feb 3 (Reuters) - The U.S. Food and Drug Administration

warned GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) (GSK.N:

Quote, Profile, Research) on Thursday over misleading advertisements

touting its hypertension drug called Coreg.

 

The company presented the marketing information at a conference last

June, using a poster that omitted risk information and overstated how

well the drug worked, the FDA said in a letter posted on its Web site.

 

" This panel (poster) raises serious public health and safety concerns

because it fails to include any risk information about Coreg, which is

associated with serious risks, " said the letter, dated Jan. 31.

 

FDA officials also cited similar warnings the company received in 1999

and 1997 over Coreg journal advertisements. " We are concerned that you

are continuing to promote Coreg in a similarly violative manner, " they

wrote.

 

Glaxo spokeswoman Nancy Leone confirmed the company received the

letter and was " taking swift and appropriate action to address issues

covered in the warning letter. "

 

Coreg, a beta-blocker drug, is approved to treat congestive heart

failure, high blood pressure and ventricle problems that follow a

heart attack.

 

Complications can include worsening chest pain and heart attacks,

especially when stopping the drug abruptly. Dizziness, and hypotension

are also common reactions. But the poster did not include the risks

and instead directed readers to find them from another publication

source, the FDA said.

 

The letter also said graphics were used in such a way to suggest that

the drug led to some benefits that were never proven in clinical trials.

 

The FDA's main concern is " how data was being graphically displayed or

represented, " which could be resolved by changing the poster's layout,

Leone said. She did not elaborate about the risk information.

 

Glaxo had also addressed problems concerning the earlier journal ads,

Leone said.

 

The FDA issues dozens of warning letters each year, and most cases are

resolved without penalty. But the agency can levy fines, injunctions

and other penalties.

 

Glaxo's stock closed down 39 cents to $44.65, on the New York Stock

Exchange on Thursday after earlier closing down 0.51 percent on the

London Stock Exchange.

 

The letter is posted online at

http://www.fda.gov/cder/warn/2005/12751.pdf.

 

 

© Reuters 2005. .