FDA approves OTC single-pill Plan B
Emergency contraception use up sharply
HealthDay News -- The FDA has approved the single-pill Plan B One-Step emergency contraceptive for OTC purchase by any female of childbearing potential, without age restrictions.
The agency's announcement this week followed an April ruling by Judge Eward Korman of the U.S. District Court's Eastern District of New York mandating that all restrictions on the product be removed.
The two-pill version of the emergency contraceptive still remains restricted to those aged 17 and older.
Plan B is meant to reduce the chances of pregnancy if taken within 72 hours of unprotected sex or suspected contraceptive failure. The product was first approved in 2009 as an over-the-counter option for women 17 and older, and as a prescription option for younger females.
The product will not end the pregnancy of a female who is already pregnant, and there is no evidence that it will harm a developing fetus, the FDA said in a news release. It will not prevent any sexually transmitted disease, including HIV/AIDS, the agency added.
Some females who have taken Plan B have reported these side effects: nausea, vomiting, stomach pain, headache, dizziness and breast tenderness. These adverse reactions are similar to those reported after use of other birth control products, the FDA said.
Plan B is produced by Teva Women's Health, a unit of the Israeli drug maker Teva Pharmaceutical Industries.