"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"...
Jadelle® (levonorgestrel implants (unavailable in us)) implants were used by 1393 subjects during clinical trials. The adverse medical events reported by subjects during these trials are given below.
Various menstrual complaints reported by more than 1.0% of subjects during the first year of Jadelle® (levonorgestrel implants (unavailable in us)) use are listed below.
|Menstrual Condition||Year 1||Years 1-5|
|Menorrhagia (increased duration)||13.4||25.9|
|Long spotting duration or length unclear||8.9||15.1|
|Menorrhagia (increased amount)||1.6||4.5|
|a Excludes women with condition reported at admission, prior to initiation of Jadelle® implants.|
Insertion and Removal Difficulties
Removal complications or difficulties, including damage to the implants, were reported in 7.5% of the more than 1,100 Jadelle® (levonorgestrel implants (unavailable in us)) removals. Complications of insertion or removal included deep placement, multiple or long incisions, bruising, displacement, pain, prolonged removal, incomplete removal requiring an additional visit or visits, broken implants, and fibrous pericapsular tissue. See also Warnings Based On Experience With Levonorgestrel-Containing Implants.
Other Adverse Events
Adverse reactions that were reported by 10% or more of the subjects during 5 years of Jadelle® (levonorgestrel implants (unavailable in us)) use in clinical trials are listed below.
|Application site reaction, pain, etc.||Nausea|
|Headache||Urinary tract symptoms, infection|
|a) includes also genital pruritus, infections and vaginal problems not else where classified.|
Adverse reactions that were reported by 1.0-9.9% of the subjects during 5 years of Jadelle® (levonorgestrel implants (unavailable in us)) use in clinical trials are listed below.
|Abdominal pain||Flu-like symptoms|
|Benign breast neoplasm||Nonpuerperal lactation|
|Breast fibroadenosis||Ovarian cyst, follicle enlargement|
|Cervical cytology, grade 3 or 4||Perineal pain|
|Constipation, flatulence, or dyspepsia||Purpura|
|Dermatitis||Upper respiratory infectiona|
|a) includes rhinitis, pharyngitis and sinusitis as well as
undefined upper respiratory infection
b) includes genital ulceration, herpes simplex and papilloma virus and other vulvar disorders
Read the Jadelle (levonorgestrel implants (unavailable in us)) Side Effects Center for a complete guide to possible side effects
Jadelle® (levonorgestrel implants (unavailable in us)) implants are not recommended for women who require chronic use of phenytoin, phenobarbital, carbamazepine or oxcarbazepine because Jadelle® (levonorgestrel implants (unavailable in us)) is likely to be less effective for these women. Although the large clinical trials of NORPLANT® and of Jadelle® (levonorgestrel implants (unavailable in us)) implants excluded women with epilepsy, there are published studies showing decreased levonorgestrel concentrations in women taking these antiepileptic drugs along with levonorgestrel-containing contraceptives. These drugs may increase the metabolism of levonorgestrel through induction of microsomal liver enzymes. For women receiving long-term therapy with hepatic enzyme inducers, a different method of contraception should be considered. Women on short-term therapy with hepatic enzyme inducers should consider using a back-up method of contraception (such as condoms or spermicides) for the duration of therapy.
Rifampicin is known to decrease the effectiveness of combination oral contraceptives; its effect on levonorgestrel concentrations has not been established. Data from clinical trials of NORPLANT® implants, however, indicate low serum concentrations and subsequent pregnancy in one woman using rifampicin.
Herbal products containing St. John's Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and may reduce the effectiveness of contraceptive steroids.
Laboratory Test Interactions
Certain endocrine tests may be affected by Jadelle® (levonorgestrel implants (unavailable in us)) use:
- SHBG concentrations are decreased.
- Thyroxine concentrations may be slightly decreased and triiodothyronine uptake increased.
Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Jadelle 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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