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warnings
WARNINGS 1. Intrauterine Pregnancy If intrauterine pregnancy occurs with ParaGard ® in place and the string is visible, ParaGard ® should be removed because of the risk of spontaneous abortion, premature delivery, sepsis, septic shock, and, rarely, death. Removal may be followed by pregnancy loss. If the string is not visible, and the woman decides to continue her pregnancy, check if the ParaGard ® is in her uterus (for example, by ultrasound). If ParaGard ® is in her uterus, warn her that there is an increased risk of spontaneous abortion and sepsis, septic shock, and rarely, death. 1 In addition, the risk of premature labor and delivery is increased. 1 Human data about risk of birth defects from copper exposure are limited. However, studies have not detected a pattern of abnormalities, and published reports do not suggest a risk that is higher than the baseline risk for birth defects. 2. Ectopic Pregnancy Women who become pregnant while using ParaGard ® should be evaluated for ectopic pregnancy. A pregnancy that occurs with ParaGard ® in place is more likely to be ectopic than a pregnancy in the general population. However, because ParaGard ® prevents most pregnancies, women who use ParaGard ® have a lower risk of an ectopic pregnancy than sexually active women who do not use any contraception. 2-3 3. Pelvic Infection Although pelvic inflammatory disease (PID) in women using IUDs is uncommon, IUDs may be associated with an increased relative risk of PID compared to other forms of contraception and to no contraception. The highest incidence of PID occurs within 20 days following insertion. Therefore, the visit following the first post-insertion menstrual period is an opportunity to assess the patient for infection, as well as to check that the IUD is in place. (See INSTRUCTIONS FOR USE , Continuing Care .) Since pelvic infection is most frequently associated with sexually transmitted organisms, IUDs are not recommended for women at high risk for sexual infection. Prophylactic antibiotics at the time of insertion do not appear to lower the incidence of PID. 4 PID can have serious consequences, such as tubal damage (leading to ectopic pregnancy or infertility), hysterectomy, sepsis, and, rarely, death. It is therefore important to promptly assess and treat any woman who develops signs or symptoms of PID. Guidelines for treatment of PID are available from the Centers for Disease Control and Prevention (CDC), Atlanta, Georgia at www.cdc.gov or 1-800-311-3435. Antibiotics are the mainstay of therapy. Most healthcare professionals also remove the IUD. The significance of actinomyces-like organisms on Papanicolaou smear in an asymptomatic IUD user is unknown, 5-6 and so this finding alone does not always require IUD removal and treatment. However, because pelvic actinomycosis is a serious infection, a woman who has symptoms of pelvic infection possibly due to actinomyces should be treated and have her IUD removed. 4. Immunocompromise Women with AIDS should not have IUDs inserted unless they are clinically stable on antiretroviral therapy. Limited data suggest that asymptomatic women infected with human immunodeficiency virus may use intrauterine devices. Little is known about the use of IUDs in women who have illnesses causing serious immunocompromise. Therefore these women should be carefully monitored for infection if they choose to use an IUD. The risk of pregnancy should be weighed against the theoretical risk of infection. 5. Embedment Partial penetration or embedment of ParaGard ® in the myometrium can make removal difficult. In some cases, surgical removal may be necessary. 6. Perforation Partial or total perforation of the uterine wall or cervix may occur rarely during placement, although it may not be detected until later. Spontaneous migration has also been reported. If perforation does occur, remove ParaGard ® promptly, since the copper can lead to intraperitoneal adhesions. Intestinal penetration, intestinal obstruction, and/or damage to adjacent organs may result if an IUD is left in the peritoneal cavity. Pre-operative imaging followed by laparoscopy or laparotomy is often required to remove an IUD from the peritoneal cavity. 7. Expulsion Expulsion can occur, usually during the menses and usually in the first few months after insertion. There is an increased risk of expulsion in the nulliparous patient. If unnoticed, an unintended pregnancy could occur. 8. Wilson’s Disease Theoretically, ParaGard ® can exacerbate Wilson’s disease, a rare genetic disease affecting copper excretion.
ADVERSE REACTIONS The most serious adverse events associated with intrauterine contraception are discussed in WARNINGS and PRECAUTIONS . These include: Intrauterine pregnancy Pelvic infection Septic abortion Perforation Ectopic pregnancy Embedment Table 2 shows discontinuation rates from two clinical studies by adverse event and year. Table 2. Summary of Rates (No. per 100 Subjects) by Year for Adverse Events Causing Discontinuation Adverse Event Year 1 2 3 4 5 6 7 8 9 10 Pregnancy 0.7 0.3 0.6 0.2 0.3 0.2 0.0 0.4 0.0 0.0 Expulsion 5.7 2.5 1.6 1.2 0.3 0.0 0.6 1.7 0.2 0.4 Bleeding/Pain 11.9 9.8 7.0 3.5 3.7 2.7 3.0 2.5 2.2 3.7 Other Medical Event 2.5 2.1 1.6 1.7 0.1 0.3 1.0 0.4 0.7 0.3 No. of Women at Start of Year 4932 3149 2018 1121 872 621 563 483 423 325 *Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the Population Council (3,536 subjects) and the World Health Organization (1,396 subjects) trials. The following adverse events have also been observed. These are listed alphabetically and not by order of frequency or severity. Anemia Menstrual flow, prolonged Backache Menstrual spotting Dysmenorrhea Pain and cramping Dyspareunia Urticarial allergic skin reaction Expulsion, complete or partial Vaginitis Leukorrhea