Safety Considerations

Safety Profile

Paragard® should not be placed when one or more of the following conditions exist:

  • Pregnancy or suspicion of pregnancy
  • Abnormalities of the uterus resulting in distortion of the uterine cavity
  • Acute pelvic inflammatory disease (PID)
  • Postpartum endometritis or postabortal endometritis in the past 3 months
  • Known or suspected uterine or cervical malignancy
  • Uterine bleeding of unknown etiology
  • Untreated acute cervicitis or vaginitis or other lower genital tract infection
  • Conditions associated with increased susceptibility to pelvic infections
  • Wilson’s disease
  • A previously placed IUD or IUS that has not been removed
  • Hypersensitivity to any component of Paragard including copper or any of
    the trace elements present in the copper component of Paragard

Warnings and Precautions

  • Ectopic pregnancy
  • Risks with Intrauterine Pregnancy
  • Sepsis
  • Pelvic Inflammatory Disease (PID) and Endometritis
  • Embedment
  • Perforation
  • Expulsion
  • Wilson’s disease
  • Bleeding pattern alterations
  • MRI safe under certain conditions
  • Medical diathermy may cause health effects

Adverse Reactions

Summary of rates* (no. per 100 subjects) by year for adverse reactions causing discontinuation

* Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the US Composite Study (3536 subjects) and the World Health Organization (1396 subjects) trials.

The following adverse reactions have also been observed: anemia, backache, dysmenorrhea, dyspareunia, complete or partial expulsion, prolonged menstrual flow, menstrual spotting, pain and cramping, vaginitis.

The most serious adverse events associated with Paragard include:

  • Ectopic pregnancy
  • Intrauterine pregnancy
  • Septic abortion
  • Group A Streptococcal Sepsis (GAS)
  • Pelvic inflammatory disease and endometritis
  • Embedment
  • Perforation
  • Expulsion
  • Bleeding pattern alterations

The following adverse events have also been observed:

  • Anemia
  • Backache
  • Dysmenorrhea
  • Dyspareunia
  • Complete or partial expulsion
  • Prolonged menstrual flow
  • Menstrual spotting
  • Pain and cramping
  • and Vaginitis

Important Safety Information

  • Paragard must not be used by women who had a post-pregnancy or post-abortion uterine infection in the past 3 months; have cancer of the uterus or cervix; acute pelvic inflammatory disease (PID); an infection of the cervix; an allergy to any component (including copper); or Wilson’s disease. Continue reading

Indication

Paragard is a copper-containing IUS (intrauterine system) indicated for the prevention of pregnancy for up to 10 years.

Important Safety Information

  • Paragard must not be used by women who had a post-pregnancy or post-abortion uterine infection in the past 3 months; have cancer of the uterus or cervix; acute pelvic inflammatory disease (PID); an infection of the cervix; an allergy to any component (including copper); or Wilson's disease.
  • If a woman misses her period, she must be promptly evaluated for ectopic pregnancy.
  • Possible serious complications that have been associated with IUSs are PID, embedment, perforation of the uterus, and expulsion.
  • Paragard must not be used by pregnant women as this can be life threatening and may result in loss of pregnancy or infertility.
  • Menstrual cycles may become heavier and longer with intermenstrual spotting. Bleeding may be heavier than usual at first.
  • Paragard does not protect against HIV or STIs.

Please see accompanying Full Prescribing Information.

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