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1
Nexplanon's usage duration extended to five years by the FDA.
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2
Approval based on zero pregnancies and consistent safety in extended use.
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3
Involved a study of 399 women aged 18-
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4
REMS to ensure safe insertion and removal of the implant.
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5
No new adverse reactions reported; menstrual changes remained common.
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6
Covers a diverse BMI range, highlighting broader patient access.
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The FDA has approved an extension of the etonogestrel implant (Nexplanon) usage duration for pregnancy prevention from three years to five years. This decision is based on clinical trials that showed sustained contraceptive efficacy and a consistent safety profile during the extended use. The multicenter study involved 399 women, demonstrating no pregnancies occurred during years 4 and 5. A Risk Evaluation and Mitigation Strategy (REMS) will accompany the product to ensure safe insertion and removal by certified providers. According to Dr. Anita Nelson, this update enhances access for diverse patient populations seeking long-acting contraceptive solutions.
-
1
Nexplanon's usage duration extended to five years by the FDA.
-
2
Approval based on zero pregnancies and consistent safety in extended use.
-
3
Involved a study of 399 women aged 18-
-
4
REMS to ensure safe insertion and removal of the implant.
-
5
No new adverse reactions reported; menstrual changes remained common.
-
6
Covers a diverse BMI range, highlighting broader patient access.
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