Tuesday, December 26, 2006

Changes to IUD Prescribing Information

Here's a good summary of the recent changes to the prescribing information (.pdf) for the copper T380A IUD (ParaGard). Some highlights:

- The IUD is the most widely used reversible birth control method in the world.

- Contraceptive efficacy* of the copper IUD is among the highest of all available birth control methods.

* Note this emerging trend in efficacy counseling:

Women report that the most important criterion for choosing a contraceptive is how well it works. However, many women do not fully understand the differences in efficacy among the various methods of contraception or the difference between "typical" and "perfect" use data. Perfect use data should not be used in counseling patients because they are not reflective of real-life practices. [Without any hard data on typical use efficacy, where does that leave abstinence counseling?] Steiner et al have proposed a simplified approach that communicates contraceptive effectiveness better than traditional tables with numeric estimates of pregnancy risk (TABLE 2). This table categorizes sterilization, implants, hormone shots, and IUDs with and without hormones as "more effective"; oral contraceptive pills as 'effective"; and barrier methods, spermicide, and behavioral methods as 'less effective."


(What do you think about this approach? Is it something you'd be comfortable with?)

- Although the acquisition cost of an IUD may be daunting to women whose insurance plans do not provide coverage, the manufacturer does offer a payment plan which can ease the financial burden.

- [T]he copper IUD protects against pregnancy by reducing motility and viability of sperm, inhibiting ova development, and thereby preventing fertilization. This appears to be the primary mechanism of action.

- The most important labeling change was the removal of any reference to a recommended patient profile, which previously had listed parity, a stable and mutually monogamous relationship, and no history of pelvic inflammatory disease (PID) as preferred characteristics for IUD users.

- Nulliparity has never been a contraindication to IUD use.

- The recommendation to avoid IUD use in women with a history of PID has been replaced with the advice not to use an IUD in a woman with active cervicitis, PID, or current behavior suggesting high risk for PID.

- Vaginal infection is not a contraindication to insertion of the copper IUD. Abnormalities in cervical cytology also are not contraindications to IUD insertion or continued use of an IUD; only women who have a high index of suspicion for cervical or endometrial cancer should have their IUD insertion delayed until those diagnoses are ruled out. Women with mild abnormalities on their Papanicolaou test may proceed with IUD insertion prior to colposcopic evaluation.

- The copper IUD reduces a woman’s underlying risk for ectopic pregnancy by 90% and can be used by women with a history of ectopic pregnancy to reduce their risk of recurrence.

- The risk that a pregnancy is ectopic is 8% with copper IUD use; after tubal sterilization, this risk exceeds 20%.

- The copper IUD may be inserted at any time in the menstrual cycle when pregnancy can be reasonably ruled out....Insertion immediately after first-trimester abortion (induced and spontaneous) is both safe and effective.

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