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...]
Risk of Lower Limb Amputations Doubled with Invokana and Invokamet Use
As of yesterday, May 16, 2017, the FDA issued a Drug Safety Communication regarding an increased risk of leg and foot amputations due to use of popular diabetes drugs Invokana, Invokamet, and Invokamet XR, which contain canagliflozin. These drugs belong to the sodium glucose cotransporter 2 (SGLT2) inhibitor class, and are the subjects of … [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...]
EMA Warns that Some Diabetes Drugs Cause Increased Risk of Amputation
Earlier today, February 10, 2017, the European Medicines Agency (EMA) released the findings of their Pharmacovigilance Risk Assessment Committee (PRAC) concerning the link between particular diabetes drugs and an increased risk of toe amputation. These diabetes drugs are part of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of … [Read more...]