drugs information
Paragard Black Box Warning
Market Name: Paragard
Paragard, otherwise known as an intra-uterine device (IUD), has been approved by the FDA as a birth control method for over twenty years. Paragard is hormone-free and uses copper as its active ingredient.
While Paragard is an effective birth control method, it can cause ectopic pregnancy, immune system disorders, pelvic infection, embedment, perforation, expulsion, wilson's disease, vaginal bleeding, vasovagal reactions and fainting. The FDA added a black box warning to Paragard's prescribing information in September of 2005.
Black Box Warning Date: September 2005
FDA Link: Paragard