Copper is a copper-containing intrauterine device sold in the U.S. under 3 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Cu-7 (application NDA017408). Other copper products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Insert a single Miudella at the fundus of the uterine cavity. Miudella must be removed or replaced after 3 years. ( 2.1 ) Insert Miudella only if you are a trained healthcare provider using clean technique. Follow insertion instructions exactly as described. ( 2.1 ) See the Full Prescribing Information for recommended timing of insertion, preparation instructions, insertion procedures, postplacement management, and instructions on removing Miudella. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) Patient can be re-examined as clinically indicated. 2.1 Important Dosage and Administration Instructions Miudella is supplied sterile in a sealed package with a sterile single use inserter for placement. Do not open the package until required for insertion. Do not use if the seal of the sterile package is broken or appears compromised. Before considering use of Miudella, make sure that the patient is an appropriate candidate for Miudella. Exclude pregnancy (consider the possibility of ovulation and conception) prior to use [see Contraindications (4) and Warnings and Precautions (5) ]. Only a healthcare provider should insert Miudella. Healthcare providers should be thoroughly familiar with the product, product educational materials, product insertion instructions, and prescribing information before inserting Miudella. The IUS is provided preloaded in the inserter (see Figure A ). Remove Miudella on…
The following serious adverse reactions are discussed elsewhere in the labeling: Ectopic pregnancy [see Warnings and Precautions (5.3) ] Intrauterine pregnancy [see Warnings and Precautions (5.4) ] Sepsis [see Warnings and Precautions (5.5) ] Pelvic Infection [see Warnings and Precautions (5.6) ] Perforation [see Warnings and Precautions (5.7) ] Expulsion [see Warnings and Precautions (5.8) ] Wilson's Diseas e [see Warnings and Precautions (5.9) ] Bleeding Pattern Alteration [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥ 5%) are: heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post procedural hemorrhage, dyspareunia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon USA LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure of 1,904 healthy 17- to 45-year-old women (mean age 27.5 ± 5.72 years) to Miudella. These data come from two multi-center contraceptive trials with a 3-year…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | Not yet rated | Prescription | IUD | — | — | View → | |
| 2 | Not yet rated | Supplement |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
The use of Miudella is contraindicated when one or more of the following conditions exist: Pregnancy or suspicion of pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1) ] Congenital or acquired abnormalities of the uterus, including leiomyomas, resulting in distortion of the uterine cavity Acute pelvic inflammatory disease (PID) [see Warnings and Precautions (5.6) ] Postpartum endometritis or postabortal endometritis in the past 3 months. [see Warnings and Precautions (5.6) ] Known or suspected uterine or cervical malignancy For use as post-coital contraception (emergency contraception) Uterine bleeding of unknown etiology Untreated acute cervicitis or vaginitis or other lower genital tract infection Conditions associated with increased susceptibility to pelvic infections [see Warnings and Precautions (5.6) ] Wilson's disease [see Warnings and Precautions (5.9) ] A previously placed IUS that has not been removed Hypersensitivity to any component of Miudella including to polypropylene, copper, nitinol, an alloy of nickel and titanium, or any of the trace elements present in the copper component of Miudella [see Adverse Reactions (6) and Description (11) ] . Persons with allergic reactions to these components may suffer an allergic reaction to this intrauterine system. Prior to placement, patients should be counseled on the materials contained in…
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| 3 | Not yet rated | Prescription | IUD | — | — | View → |