{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "copper",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Insert a single Paragard at the fundus of the uterine cavity. Remove Paragard no later than 10 years from the date of insertion. ( 2.1 ) Insert and remove Paragard only if you are a healthcare provider trained on these procedures. ( 2.1 ) See the Full Prescribing Information for recommended timing of insertion preparation instructions, insertion procedures, postplacement management, and instructions on removing Paragard.",
        "source": "US FDA label for copper (ParaGard T 380A), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/copper.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "No child dose in this label. That usually means untested in children, not unsuitable - use a paediatric source.",
        "source": "Read and found silent: the US FDA label for copper (ParaGard T 380A), retrieved 2026-08-29",
        "cached_file": "labels/copper.json",
        "verbatim": false
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for copper (ParaGard T 380A), retrieved 2026-08-29",
        "cached_file": "labels/copper.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for copper (ParaGard T 380A), retrieved 2026-08-29",
        "cached_file": "labels/copper.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Use of Paragard is contraindicated for use in pregnant females because there is no need for pregnancy prevention in a female who is already pregnant and Paragard may cause adverse pregnancy outcomes.",
        "source": "US FDA label for copper (ParaGard T 380A), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/copper.json",
        "verbatim": true
      },
      {
        "text": "If a female becomes pregnant with Paragard in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 , 5.2 ) ] .",
        "source": "US FDA label for copper (ParaGard T 380A), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/copper.json",
        "verbatim": true
      },
      {
        "text": "Advise the female of the potential risks if pregnancy occurs with Paragard in place.",
        "source": "US FDA label for copper (ParaGard T 380A), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/copper.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Studies on Paragard and birth defects have not been conducted. 8.2 Lactation Risk Summary No difference has been detected in concentration of copper in human milk before and after insertion of copper IUSs, including Paragard.",
        "source": "US FDA label for copper (ParaGard T 380A), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/copper.json",
        "verbatim": true
      },
      {
        "text": "There is no information on the effect of copper in a breastfed child or the effect on milk production.",
        "source": "US FDA label for copper (ParaGard T 380A), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/copper.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Paragard and any potential adverse effects on the breastfed child from Paragard. 8.4 Pediatric Use The safety and effectiveness of Paragard have been established in females of reproductive potential.",
        "source": "US FDA label for copper (ParaGard T 380A), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/copper.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "avoid",
      "line": "The label says not to use it. Read the quote below before deciding.",
      "set_by": "Set from the label's own words, not from a reading of them: 'contraindicated for use in pregnan'."
    }
  }
}