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Pregnant women frightened unnecessarily

Media release

3 May 2003

Pregnant women have been unnecessarily frightened by outrageous claims in a Sydney newspaper about substandard folate tablets, the Therapeutic Goods Administration's Principal Medical Adviser, Dr John McEwen, said today.

Dr McEwen totally rejected any suggestion that the TGA had hidden vital safety information about some folate supplements from the public.

"It is wrong that 10 out of 51 tablets containing folate didn't meet Australian standards.

"Australia has always prided itself on adopting world leading standards in the regulation of complimentary medicines and taking decisive action when significant and immediate risk to health and safety is found.

"The TGA has worked closely with the complementary medicines expert committee to ensure that this world leading position is maintained."

Dr McEwen said as part of moves to tighten standards, which have been progressively introduced from November of last year, some exploratory testing was done in 2001. This identified that 10 Australian products did not meet a new US standard for dissolution.

"In order to maintain our world leading position and on the advice of CMEC it was agreed that a new standard would be introduced. This has been done. Even now, European standards do not include any requirement for dissolution," he said.

Dr McEwen said that women should not be alarmed. I can assure Australian women that if there had been any safety concerns these products would have been recalled.

"As part of the testing process we identified 3 multivitamin products (which included folate) that did not meet the then existing standard for disintegration which is 30 minutes. Two products exceeded the standard by 1 minute and one by five minutes.

"Immediate action in relation to these products was taken consistent with the TGA's high standard of regulatory response."

Media contact: Kay McNiece 0412 132 585