"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"...
The following adverse reactions have been associated with the NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM during the first year of use in clinical trials:
|Many bleeding days or prolonged bleeding||27.6%|
|Irregular (onsets of) bleeding||7.6%|
|Frequent bleeding onsets||7.0%|
|Pain or itching near implant site (usually transient)||3.7%|
|Infection at implant site||0.7%|
In addition, removal difficulties affecting subjects (including multiple incisions, capsule fragments remaining, pain, multiple visits, deep placement, lengthy removal procedure, or other) have been reported with a frequency of 6.2%, which is based on 849 removals occurring through 5 years of use. See “WARNINGS” and “PRECAUTIONS.”
Clinical studies comparing NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM users with other contraceptive method users suggest that the following adverse reactions occurring during the first year are probably associated with NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM use. These adverse reactions have also been reported post-marketing:
|Nervousness/Anxiety||Change of appetite|
|Adnexal enlargement||Hirsutism, hypertrichosis,|
|Dermatitis/Rash||and scalp-hair loss|
In addition, the following adverse reactions have been reported in clinical trials with a frequency of 5% or greater during the first year and are possibly related to NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM use:
|Breast discharge||Abdominal discomfort|
The following adverse reactions have been reported post-marketing with an incidence of less than 1% and are possibly related to NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM use:
Idiopathic intracranial hypertension (IIH) (pseudotumor cerebri, benign intracranial hypertension)
Insertion/removal site reactions including abscess, cellulitis; blistering; bruising; edema; excessive scarring; hyperpigmentation; induration; nerve injury; numbness; sloughing; tingling;
The following adverse reactions have been reported post-marketing and a causal relationship to the NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM has not been established:
Deep vein thrombosis
Emotional lability and depression, sometimes severe
Superficial venous thrombosis
Thrombotic thrombocytopenic purpura (TTP)
Vaginal bleeding, heavy
Weight gain of more than 10 pounds
Read the Norplant (levonorgestrel implants (unavailable in us)) Side Effects Center for a complete guide to possible side effects
Reduced efficacy (pregnancy) has been reported for NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM users taking phenytoin and carbamazepine. These drugs may increase the metabolism of levonorgestrel through induction of microsomal liver enzymes. NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM users should be warned of the possibility of decreased efficacy with the use of drugs exhibiting enzyme-inducing activity such as those noted above and rifampin. For women receiving long-term therapy with hepatic enzyme inducers, another method of contraception should be considered.
Drug/Laboratory Test Interactions
Certain endocrine tests may be affected by NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM use:
- Sex-hormone-binding globulin concentrations are decreased.
- Thyroxine concentrations may be slightly decreased and triiodothyronine uptake increased.
Last reviewed on RxList: 1/5/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Norplant 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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