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Why didn't alarm bells ring over Eltroxin results


Jackie Blue MP
National Party Associate Health Spokeswoman (Pharmacare)

15 September 2008

Explanation wanted as to why alarm bells didn't ring over Eltroxin results

National's Associate Health spokeswoman, Jackie Blue, says there were obvious clues that there could well be problems with the new formulation of Eltroxin.

She is commenting on a response to a parliamentary written question which provided results of bioequivalence tests performed on the new formulation.

"The 36 test subjects in the study were randomly assigned either the new formulation Eltroxin or the standard preparation, and monitored for 48 hours over which time blood levels were taken and adverse events recorded.

"After the drug left their system they received the opposite drug and were followed for another 48 hours.

"Almost 25% of the subjects experienced an adverse event when taking the new formulation of Eltroxin, compared to just 8% taking the standard formulation.

"I'm not an expert in these sorts of tests but the fact that nearly three times as many people had problems with the new formulation would have raised my eyebrows.

"The authorities need to explain why this information did not ring alarm bells for them.

"If this had been flagged earlier we might have avoided the debacle that has seen more than 800 adverse effects reported to the Centre for Adverse Reactions Monitoring.

ENDS

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