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Uterine Fibroid Drug Esmya Investigated Due to Severe Liver Injuries

February 22, 2018 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Drugs Tagged With: EMA, esmya, esmya side effects, European Medicines Agency, hepatic failure, liver failure, liver injury, liver transplants, Pharmacovigilance Risk Assessment Committee, PRAC, ulipristal acetate, uterine fibroids treatments

EU Calls for Strengthened and Revised Warnings for MS Drug Gilenya

December 19, 2017 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Drugs Tagged With: cardiovascular events, drug label warnings, EMA, EU, European Medicines Agency, FDA, fingolimod, food and drug administration, Gilenya, gilenya side effects, immunosuppressive drugs, lymphoma, MHRA, MS drugs, multiple sclerosis drugs, pml, serious infections, skin cancers

Was I properly warned about the side effects of Depakote/Depakene/Depacon?

September 27, 2017 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Drugs Tagged With: bipolar disorder drugs side effects, birth defects, depacon, depakene, depakote, EMA, epilepsy drugs side effects, European Medicines Agency, fetal birth defects causes, medical malpractice cases, prescription drug side effects, spina bifida causes, Stavzor, valproate, valproic acid

Safety of Uptravi Drug Investigated After Five Patient Deaths Occur

February 15, 2017 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Drugs Tagged With: blood pressure drugs, drug injury lawsuit, drug safety review, drug side effect, EMA, European Medicines Agency, Pharmacovigilance Risk Assessment Committee, PRAC, pulmonary arterial hypertension, selexipag, uptravi

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