Millions of people in the UK who take the cholestrol-busting drug statins have been urged to 'be alert' for symptoms of a rare long-term condition which causes muscle weakness
taking the drug during pregnancy. sodium valproate was first prescribed in the uk in the 19705. patients were warned that there was a small chance of spina bifida. but it wasn t until 2005, that the risks of taking the drug during pregnancy were clearly listed on the patient information leaflet, which should come with a prescription. we ve now discovered new evidence showing information about the extent of malformations notified by sanofi to health regulators, that weren t passed on to patients between 1994 and 2005. 547 reports in total, which would also have been passed on to the uk s health regulator. the table represents widespread complications that mothers and their children have had from taking sodium valproate during pregnancy. there s been a significant delay between the evidence of these complications, which are shown in the table, and actually, action from our regulators. and in that period, many women have
been harmed, and their children. there s also emerging research about the possible risks of children fathered by men taking sodium valproate, an increase in the risk of neurodevelopmental disorders like autism. ben s been taking this drug for 20 years. he and his wife, lauren, are expecting a baby in october, and he s worried. these are potentially life changing situations for people. and you ve got to be armed with all the information - you have before for that situation. so, i think for me - it s incredibly frustrating that that hasn t happened - and the research that s been done needs to be communicated much more to a wider audience, especially people that it s going to affect. i both the drug company sanofi and the health regulator, the mhra, told us there were warnings in the patient information leaflet in 2003, which were then strengthened in 2005. sanofi said it continued to ensure reports of adverse effects, emerging safety concerns,
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