|
|
|
|
|
|
|
|
|
|
NEW YORK, Mar 28 (Reuters Health) - Promotional materials that claim an antibiotic can treat resistant bacteria and is cost effective are misleading, the US Food and Drug Administration (FDA) charges.
The FDA has issued a letter to Lifecycle Ventures, which signed a five-year contract in late 2000 to promote, market and distribute the GlaxoSmithKline drug Ceftin (cefuroxime axetil). The drug has been approved to treat a number of infections, including those of the lower respiratory tract, urinary tract and skin.
Materials produced by Lifecycle violate the Federal Food, Drug and Cosmetic Act because they promote the antibiotic for uses that have not been approved, and make misleading economic claims, the FDA said in the letter, which was posted on the agency's Web site on Wednesday.
The agency specifically objects to tag lines used in the material, which include "First-line in an era of bacterial resistance" and "In an era of drug-resistant streptococcus pneumoniae." The FDA charges that the lines are placed close to information about how to treat ear infections, sinusitis and bronchitis "and imply that Ceftin is approved or all listed pathogens, including resistant organisms."
In fact, the drug "is not approved to treat drug-resistant infections, such as resistant streptococcus pneumonia and resistant haemophilus influenzae," the FDA said.
In addition, the agency maintained that cost analyses contained in the promotional material comparing Ceftin and other antibiotics are misleading because they "imply that all costs associated with therapy have been evaluated, not simply the acquisition price of the drug." The promotional materials tout Ceftin as being "cost-effective" and claim that the product will help "manage the expense of treatment."
The FDA's letter instructs Lifecycle to "immediately cease distribution of the sales aids and other similar promotional materials for Ceftin that contain the same or similar claims or presentations." The company also has been asked to submit a response to the agency by March 30.
Lifecycle, which is part of the contracted sales company Professional Detailing Inc., signed a 5-year contract with GlaxoSmithKline in late 2000 to market and distribute Ceftin,
Company officials were not immediately available for comment.
| Health Topics | Drug Information | Dictionaries | Directories | Other Resources |
|
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
Copyright and Privacy Policy, We welcome your comments. Last updated: 30 March 2001 |