1/ Horrified to receive this mail today. “The U.S. Food and Drug Administration (FDA) is requesting REMOVAL of its STRONGEST WARNING against using cholesterol-lowering Statin medicines in pregnant patients. Despite the change, most patients should stop statins once they
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2/ learn they are pregnant. So which is it 🙄?
When the FDA approved the first Statin in 1987, the drug came with the strongest warning recommending against use during pregnancy and breastfeeding. This was based on several factors.
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When the FDA approved the first Statin in 1987, the drug came with the strongest warning recommending against use during pregnancy and breastfeeding. This was based on several factors.
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3/ These were safety signals from animal data at drug exposures higher than human doses, potential concern that lowering cholesterol may negatively affect the unborn baby or infant, and the perspective that short-term use during pregnancy and breastfeeding did not provide
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4/ a substantial benefit to the mother. All statins approved subsequently have carried the same warning. (So what changed ?)
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5/ Smith–Lemli–Opitz syndrome is an inborn error of cholesterol synthesis. It is an autosomal recessive, multiple malformation syndrome caused by a mutation in the enzyme 7-Dehydrocholesterol reductase encoded by the DHCR7 gene.
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6/ It causes a broad spectrum of effects, ranging from mild intellectual disability and behavioural problems to lethal malformations.
Statins, by inhibiting HMG Co-enzyme A reductase will inhibit the synthesis of 7-dehydrocholesterol, the pre-cursor of cholesterol. !!!
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Statins, by inhibiting HMG Co-enzyme A reductase will inhibit the synthesis of 7-dehydrocholesterol, the pre-cursor of cholesterol. !!!
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7/ What the hell are they thinking of by doing this ?
Have they lost their minds ? 🤬
Have they lost their minds ? 🤬
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