Max
05-03-2003, 11:16 AM
TGA assures on folate safety
Saturday 3 May 2003, 8:05 PM
The Therapeutic Goods Administration (TGA) today assured pregnant women that it was safe to take folic acid supplements, after claims it covered up information that some tablets were ineffective.
Folic acid supplements decrease the risk of spina bifida - incomplete development of the spinal cord - in babies.
The Sydney Morning Herald reported that the TGA had known for two years that 10 out of 51 folic acid supplements on the Australian market would not dissolve fast enough to be effective.
It said the ineffective products were not recalled and no warnings were issued to pregnant women.
But the drug watchdog's principal medical adviser, Dr John McEwen, said the report was wrong and that pregnant women were being frightened unnecessarily.
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Dr McEwen said only three out of 51 folic acid supplements failed standard tests requiring that tablets disintegrate within 30 minutes.
Two of the tablet brands took 31 minutes to disintegrate, while the third took 35 minutes.
Dr McEwen said the failures were not considered clinically significant and did not warrant a product recall.
One of the products has since been reformulated to meet industry standards, one was withdrawn by the manufacturer and one was included in the Pan Pharmaceuticals recall, he said.
"I can assure Australian women that if there had been any safety concerns these products would have been recalled," he told reporters in Sydney today.
"The reason we didn't recall them, like we've done in the Pan situation, is clearly that these were technical failures, there was no risk of death, no risk of serious illness or injury.
"The folate tablets that remain on the Australian market ... are fine and will work to prevent (spina bifida)."
Dr McEwen said it was during experimental tests in 2001, when a stricter dissolution standard was used, that 10 of the 51 folic acid supplements failed to dissolve fast enough.
This stricter standard of testing was adopted last November for folic acid supplements with a dosage of 400 micrograms or more and from November will be used to test dosages between 100 and 400 micrograms.
Today's newspaper report prompted calls from NSW Health Minister Morris Iemma and hospital clinicians for a review of the TGA, but Dr McEwen said it was "grossly unfair" if the incorrect information eroded public confidence in the TGA.
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Saturday 3 May 2003, 8:05 PM
The Therapeutic Goods Administration (TGA) today assured pregnant women that it was safe to take folic acid supplements, after claims it covered up information that some tablets were ineffective.
Folic acid supplements decrease the risk of spina bifida - incomplete development of the spinal cord - in babies.
The Sydney Morning Herald reported that the TGA had known for two years that 10 out of 51 folic acid supplements on the Australian market would not dissolve fast enough to be effective.
It said the ineffective products were not recalled and no warnings were issued to pregnant women.
But the drug watchdog's principal medical adviser, Dr John McEwen, said the report was wrong and that pregnant women were being frightened unnecessarily.
advertisement
advertisement
Dr McEwen said only three out of 51 folic acid supplements failed standard tests requiring that tablets disintegrate within 30 minutes.
Two of the tablet brands took 31 minutes to disintegrate, while the third took 35 minutes.
Dr McEwen said the failures were not considered clinically significant and did not warrant a product recall.
One of the products has since been reformulated to meet industry standards, one was withdrawn by the manufacturer and one was included in the Pan Pharmaceuticals recall, he said.
"I can assure Australian women that if there had been any safety concerns these products would have been recalled," he told reporters in Sydney today.
"The reason we didn't recall them, like we've done in the Pan situation, is clearly that these were technical failures, there was no risk of death, no risk of serious illness or injury.
"The folate tablets that remain on the Australian market ... are fine and will work to prevent (spina bifida)."
Dr McEwen said it was during experimental tests in 2001, when a stricter dissolution standard was used, that 10 of the 51 folic acid supplements failed to dissolve fast enough.
This stricter standard of testing was adopted last November for folic acid supplements with a dosage of 400 micrograms or more and from November will be used to test dosages between 100 and 400 micrograms.
Today's newspaper report prompted calls from NSW Health Minister Morris Iemma and hospital clinicians for a review of the TGA, but Dr McEwen said it was "grossly unfair" if the incorrect information eroded public confidence in the TGA.
©2003 AAP
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Printer friendly version Email to a friend
SEARCH ALL FAIRFAX ARCHIVES (*Fee for full article)