(Reuters) – The U.S. Food and Drug Administration on Friday approved Abbvie Inc’s oral treatment for managing heavy menstrual bleeding associated with fibroids in premenopausal women.
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.
They are most common in women in the age group 35 to 49 years and a leading reason for surgical removal of the uterus in the United States.
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.
(Reporting By Mrinalika Roy in Bengaluru; Editing by Shailesh Kuber)