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Ocaliva-related Liver Injury Warnings Will be Added to Ocaliva Drug Label

June 1, 2021 By Law Offices of Thomas J. Lamb, P.A.

We now know more about the Ocaliva-related liver injury “safety signal” that the FDA has been investigating over the past year, and as a result of that Ocaliva FDA safety evaluation there will be an Ocaliva label change with new warnings. On May 26, 2021, this FDA Drug Safety Communication about Ocaliva, “Due to risk of serious liver injury, FDA … [Read more...]

Filed Under: Unsafe Drugs Tagged With: drug-induced liver injury, liver damage, liver failure, liver injury, liver transplants, Ocaliva

Actemra Liver Injury Risks Warnings Added To Drug Label In June 2019

June 18, 2019 By Law Offices of Thomas J. Lamb, P.A.

The FDA sent an email on June 13, 2019 about Drug Safety-related Labeling Changes (SrLC) which alerted us to a revised version of the Actemra Prescribing Information document used in the US. Upon review of this new section added to the “Warnings and Precautions” part of the June 2019 Actemra drug label (accessed 6/13/19): 5.3 … [Read more...]

Filed Under: Unsafe Drugs Tagged With: Actemra, drug-induced liver injury, liver injury, liver transplants

Actemra Drug-Induced Liver Injuries Warning From Health Canada

May 29, 2019 By Law Offices of Thomas J. Lamb, P.A.

Actemra drug-induced liver injuries, which can be serious, life-threatening, or even fatal. This is according the Canadian drug regulatory agency, Health Canada, which issued this Dear Healthcare Professional Letter, “Important Safety Information on ACTEMRA ® (tocilizumab) – Risk of Hepatotoxicity”, on May 21, 2019. From this Health Canada … [Read more...]

Filed Under: Uncategorized, Unsafe Drugs Tagged With: Actemra, drug-induced liver injury, liver damage, liver failure, liver transplants

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

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