to the directions incorporated into U.S. and European labels, it is an important treatment for patients with type 2 diabetes," Krall says in a news release. "We believe that important evidence coming from long-term studies supports the safety of Avandia."
Meanwhile on Monday, Henry Waxman, a Democratic senator from California and chairman of the House Oversight and Government Reform Committee, invited Glaxo CEO Jean-Pierre Garnier, FDA Commissioner Eschenbach and Dr. Steven Nissen, the author of the NEJM article, to testify before the committee on June 6.
"This is the latest reminder that FDA isn't effectively monitoring the safety of drugs used by millions of Americans once they are on the market, says Waxman. As early as March, the FDA knew Avendia's risks but it inexplicably failed to act. The American people deserve to know why the FDA failed to take action to warn doctors and patients."
According to Representative John Dingell, the chairman of the House Energy and Commerce Committee, which oversees consumer protection, the controversy surrounding Avandia is likely to have an impact on the Houses look at FDA reform.
"It is incredible that the agency charged with protecting the public health has such a poor record when it comes to post market drug safety," he says. "Regrettably it is incidents like this that demand legislative changes in the way FDA deals with drug safety. The Committee will address these dangerous shortcomings while writing legislation to reauthorize [prescription drug legislation].
Dingell and Waxman had already been alerted to the potential health risks posed by Avandia. Earlier this month, they and several other House members asked the FDA to inform them of the agencys plan to protect the public from the drugs potential harm.
The FDA has issued a safety alert for Avandia, but for the moment it is not asking Glaxo to take any specific action. FDA officials werPage: 1 2 3 4 Related medicine news :1
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