FDA禁用Ppa的计划又朝前推进(下)
But while even CHPA now supports the FDA action, the industry group previously had been in the forefront of defending PPA and its benefits, going to the extent of even criticizing its own study.
In that study, researchers from Yale University concluded that dietary products containing PPA are associated with increased risk of stroke. But at the public meeting held in October, CHPA pointed out that the researchers of the Yale study based the link on a handful of cases and that their conclusions were hampered by the inability to account for other risk factors such as smoking, illicit drug use and alcohol abuse.
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"We are back where we were when we started the study," said Dr. William Soller, a senior vice president and director of science at CHPA.
In response, the FDA said that it also believed PPA was responsible for about 200 to 500 strokes a year based upon reported events in its proprietary database. "The burden of proof now falls upon the industry to show us that it's safe," said Dr. Lois La Gernade, the lead FDA reviewer. "At a minimum, consumers should be adequately informed."
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Still, the FDA agreed that the risk was minimal. And in issuing it's advisory in November, the agency made sure to note that PPA has been used for about 50 years and that the FDA action was taken simply to ensure that Americans were not taking an unnecessary risk.
But the implications of the FDA actions could be far more widespread. Some experts have speculated that in going after PPA, the FDA actually was preparing to go after the dietary supplement Ephedra, which the body converts into PPA.
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Also known as ma haung, Ephedra is a common ingredient in dietary supplements that claim to help people lose weight and increase their energy levels.
Last year, FDA proposed banning the combination of Ephedra with caffeine. Since then, the FDA has hosted a number of meetings regarding the issue, but has taken no direct action to push or implement its proposed ban.
In total, the FDA's current action involving PPA includes the withdrawal of 16 brand name drugs and 8 generic drugs, but once again, not all PPA containing products such as the dietary aids linked to the increased incidence of stroke.
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According to the FDA, the agency intends to address these other products in future actions. In the meantime, the agency said that the sponsors of at least these drugs would now have 60 days to request a hearing or face the forced withdrawal of their product.
Sponsors of those drugs include Novartis, Teva and GlaxoSmithKline, all of which previously announced the removal of PPA in their over-the-counter cold products.
A full copy of the FDA notice can be obtained on the agency Web site at www.fda.gov. It is also available in the August 14 issue of the Federal Register., 百拇医药
In that study, researchers from Yale University concluded that dietary products containing PPA are associated with increased risk of stroke. But at the public meeting held in October, CHPA pointed out that the researchers of the Yale study based the link on a handful of cases and that their conclusions were hampered by the inability to account for other risk factors such as smoking, illicit drug use and alcohol abuse.
, http://www.100md.com
"We are back where we were when we started the study," said Dr. William Soller, a senior vice president and director of science at CHPA.
In response, the FDA said that it also believed PPA was responsible for about 200 to 500 strokes a year based upon reported events in its proprietary database. "The burden of proof now falls upon the industry to show us that it's safe," said Dr. Lois La Gernade, the lead FDA reviewer. "At a minimum, consumers should be adequately informed."
, 百拇医药
Still, the FDA agreed that the risk was minimal. And in issuing it's advisory in November, the agency made sure to note that PPA has been used for about 50 years and that the FDA action was taken simply to ensure that Americans were not taking an unnecessary risk.
But the implications of the FDA actions could be far more widespread. Some experts have speculated that in going after PPA, the FDA actually was preparing to go after the dietary supplement Ephedra, which the body converts into PPA.
, http://www.100md.com
Also known as ma haung, Ephedra is a common ingredient in dietary supplements that claim to help people lose weight and increase their energy levels.
Last year, FDA proposed banning the combination of Ephedra with caffeine. Since then, the FDA has hosted a number of meetings regarding the issue, but has taken no direct action to push or implement its proposed ban.
In total, the FDA's current action involving PPA includes the withdrawal of 16 brand name drugs and 8 generic drugs, but once again, not all PPA containing products such as the dietary aids linked to the increased incidence of stroke.
, 百拇医药
According to the FDA, the agency intends to address these other products in future actions. In the meantime, the agency said that the sponsors of at least these drugs would now have 60 days to request a hearing or face the forced withdrawal of their product.
Sponsors of those drugs include Novartis, Teva and GlaxoSmithKline, all of which previously announced the removal of PPA in their over-the-counter cold products.
A full copy of the FDA notice can be obtained on the agency Web site at www.fda.gov. It is also available in the August 14 issue of the Federal Register., 百拇医药