A host of generic medicines – including 10 UK-marketed ones – have been suspended following a malpractice discovery at an Indian firm carrying out quality control checks on the drugs. Reported on www.pulsetoday.co.uk, European Medicines Agency (EMA) advisors said bioequivalence studies carried out on the drugs at Semler Research Centre in Bangalore were ‘flawed’ and [...]
Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations. This week's Drug Safety Update from the MHRA signposts new communication materials for use by healthcare professionals. To further improve awareness of the risks of valproate in pregnancy MHRA are asking that you use the new communication materials to [...]
The MHRA has issued two drug safety alerts directed at nicorandil (Ikorel) and its potential effect on ulcer development, and the need to prescribe levonorgestrel-releasing intrauterine systems (IUS) by brand name. The MHRA is warning that nicorandil’s second line treatment for stable angina can potentially lead to ulcers progressing to complications unless the drug is [...]
