MHRA suspends new prescriptions of fibroid drug Esmya
The UK medicines regulator has said that new patients should not be prescribed Gedeon Richter’s Esmya while an EU safety probe is ongoing.
In December, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of the treatment for abnormal bleeding in women with uterine fibroids after four cases of serious liver injury - three resulting in a liver transplant - were reported among users of the drug.
Read more: http://www.pmlive.com/pharma_news/mhra_suspends_new_prescriptions_of_fibroid_drug_esmya_1223141
In December, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of the treatment for abnormal bleeding in women with uterine fibroids after four cases of serious liver injury - three resulting in a liver transplant - were reported among users of the drug.
Read more: http://www.pmlive.com/pharma_news/mhra_suspends_new_prescriptions_of_fibroid_drug_esmya_1223141