UPDATE 2-US warns Glaxo on misleading antibiotic promotion
* FDA objects to promotion for Altabax
* Company made unsupported claims -FDA
* Glaxo has told staff to stop using brochure (Adds company comment)
WASHINGTON, May 4 (Reuters) - British drugmaker GlaxoSmithKline Plc (GSK.L) (GSK.N) made unsupported claims about a skin ointment and minimized risks in a sales brochure given to doctors, U.S. health officials said in a letter released on Tuesday.
Glaxo's promotion suggested the antibiotic, Altabax, was effective in a broader range of conditions than it is approved to treat, the Food and Drug Administration said. The materials also failed to list some risks.
"These violations are concerning from a public health perspective because they suggest that Altabax is safer or more effective than has been demonstrated by substantial evidence or substantial clinical experience," the FDA said in an April 19 letter to the company.
Glaxo has told staff to stop using the brochure and is working with the FDA to resolve any remaining questions, company spokeswoman Sarah Alspach said.
"We take the FDA's concerns seriously and are carefully reviewing FDA's comments," she said.
The FDA posted the letter here. (Reporting by Lisa Richwine, editing by Gerald E. McCormick, Dave Zimmerman)
- Tweet this
- Link this
- Share this
- Digg this
- Reprints



Follow Reuters