The treatment is the first non-surgical option available to patients suffering from the condition.
Fibroids are benign muscle tumors of the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems and infertility.
The label contains a boxed warning, the FDA’s harshest, flagging concerns about increased risk of blood clots, heart attacks and strokes.
The agency also warned that women taking the drug for more than 24 months were at greater risk of bone loss.
https://www.reuters.com/article/us-abbvie-fda/fda-approves-abbvies-drug-to-control-menstrual-bleeding-due-to-fibroids-idUSKBN2352IN
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