"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.
A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Next Choice™. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Next Choice™.
Next Choice™ is not effective in terminating an existing pregnancy.
Effects on Menses
Some women may experience spotting a few days after taking Next Choice™. Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception. If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy.
Next Choice™ does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).
Physical Examination and Follow-up
A physical examination is not required prior to prescribing Next Choice™. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Next Choice™.
Fertility Following Discontinuation
A rapid return of fertility is likely following treatment with Next Choice™ for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Next Choice™ to ensure ongoing prevention of pregnancy.
Presence of FD&C Yellow #6
Next Choice™ contains FD&C Yellow #6 as a color additive.
Patient Counseling Information
Information for Patients
- Take Next Choice™ as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive failure.
- If you vomit within two hours of taking either tablet, immediately contact your healthcare provider to discuss whether to take another tablet.
- Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking Next Choice™, in order to be evaluated for an ectopic pregnancy.
- After taking Next Choice™, consider the possibility of pregnancy if your period is delayed more than one week beyond the date you expected your period.
- Do not use Next Choice™ as routine contraception.
- Next Choice™ is not effective in terminating an existing pregnancy.
- Next Choice™ does not protect against HIV-infection (AIDS) and other sexually transmitted diseases/infections.
- For women younger than age 17 years, Next Choice™ is available only by prescription.
- Next Choice™ contains FD&C Yellow #6 as a color additive.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of progestins. There was no increase in tumorgenicity following administration of levonorgestrel to rats for 2 years at approximately 5 µg/day, to dogs for 7 years at up to 0.125 mg/kg/day, or to rhesus monkeys for 10 years at up to 250 µg/kg/day. In another 7 year dog study, administration of levonorgestrel at 0.5 mg/kg/day did increase the number of mammary adenomas in treated dogs compared to controls. There were no malignancies.
Genotoxicity: Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay, in vitro mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells, and in an in vivo micronucleus assay in mice.
Fertility: There are no irreversible effects on fertility following cessation of exposures to levonorgestrel or progestins in general.
Use In Specific Populations
Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects.
In general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma.
Safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents less than 17 years and for users 17 years and older. Use of Next Choice™ emergency contraception before menarche is not indicated.
This product is not intended for use in postmenopausal women.
No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both levonorgestrel tablets and the Yuzpe regimen (another form of emergency contraception). The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown.
No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel tablets.
No formal studies were conducted to evaluate the effect of renal disease on the disposition of levonorgestrel tablets.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/19/2011
Additional Next Choice Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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