FDA SAFETY Changes,Mirena

Hi,Ladies I also found this tonight....
Have a good weekend.

September 5, 2008 —

The US Food and Drug Administration (FDA) has approved safety labeling revisions to provide updated information regarding the risks for ectopic pregnancy, sepsis, perforation, ovarian cysts, and Breast Cancer in women using a levonorgestrel-releasing intrauterine contraceptive system; drugs that are contraindicated in patients receiving linezolid therapy; and requirements for viral hepatitis screening and immunizations before treatment with abatacept is initiated.

Levonorgestrel IUD ( Mirena ) Labeling Updated Regarding Risks for Ectopic Pregnancy On May 28, the FDA approved safety labeling revisions for a long-acting levonorgestrel-releasing intrauterine contraceptive system (Mirena ; Bayer Healthcare Pharmaceuticals, Inc) to provide updated information regarding the risks for ectopic pregnancy, sepsis, perforation, ovarian cysts, and breast cancer. Women who become pregnant while using the intrauterine device (IUD) should be evaluated for ectopic pregnancy. According to the FDA, up to 50% of pregnancies that occur with the device in place are ectopic. Although ectopic pregnancy only occurred in 0.1% of women with no risk factors in clinical trials, the incidence rate may be increased in those with a previous history of its occurrence, tubal surgery, or pelvic infection.

Emphasizing the importance of aseptic technique, the FDA also warned of the risk for group A streptococcal sepsis, which had been reported in 9 of approximately 9.9 million users as of September 2006. In some cases, severe pain occurred within hours of IUD insertion and was followed by sepsis within days. Because treatment delays increase the risk for fatality, patients should be aware of the risk for this rare but serious infection, which can also occur postpartum, after surgery, and from wounds.

IUD placement has also been associated with a rare risk for perforation or penetration of the uterine wall or cervix that may not be detected until later. If perforation occurs, the device must be removed. Adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera have been reported with IUDs. To decrease perforation risk, postpartum insertion of the device should be delayed until uterine involution is complete.

Lactating women are also at increased risk for perforation. Because the contraceptive effect of the levonorgestrel IUD is mainly because of its local mechanism of action, women using the device usually have ovulatory cycles with follicular rupture.

In some cases, follicular atresia may be delayed, leading to enlarged follicles in approximately 12% of patients. Although most are asymptomatic, some follicles may cause pelvic pain or dyspareunia.

The majority of enlarged follicles spontaneously disappear during 2 or 3 months, and surgery is rarely required.

The FDA also warned that women with Breast Cancer or a history thereof should not use hormonal methods of contraception, such as the levonorgestrel IUD. Spontaneous reports of Breast Cancer have been reported during postmarketing use of the device, but the risk cannot be quantified nor a causal relationship established because of the voluntary nature of the reports from a population of uncertain size. The agency notes that 2 observational studies have not provided evidence of an increased risk for breast cancer during use of levonorgestrel IUD.


http://www.medscape.com/viewarticle/580101