About Esmya Esmya (ulipristal acetate) is indicated for the treatment of severe symptoms caused by uterine fibroids -- or noncancerous growths in the uterus -- in women of reproductive age. While Esmya is currently available in Europe, it is still pending FDA approval in the U.S. The active ingredient, ulipristal acetate is the same as that … [Read more...]
EU Calls for Strengthened and Revised Warnings for MS Drug Gilenya
UPDATE: On December 15, 2017, the FDA released an updated drug label for Gilenya with increased warnings. (12/27/17). Background After conducting a routine review of the immunosuppressive drug Gilenya (fingolimod), the Medicines and Healthcare Products Regulatory Agency (MHRA) recently suggested that the drug label for Gilenya be … [Read more...]
Was I properly warned about the side effects of Depakote/Depakene/Depacon?
As discussed in my last article, "Should I have been prescribed Depakote / Depakene / Depacon?", it is extremely important that these drugs are properly prescribed, given their devastating potential fetal side effects. Additionally, any time that Depakote / Depakene / Depacon was prescribed to a female patient, doctors should have warned the … [Read more...]
Safety of Uptravi Drug Investigated After Five Patient Deaths Occur
Yesterday, February 14, 2017, Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) issued a statement that it would be reviewing the safety of Uptravi after the deaths of five patients in France who were taking the drug. Uptravi (selexipag) is used as a long-term treatment for pulmonary arterial hypertension, … [Read more...]