Plan B Contraceptive Approved for All Females of Childbearing Age
FRIDAY, June 21 -- The Plan B "emergency" contraceptive (levonorgestrel) has been approved by the U.S. Food and Drug Administration for any female of child-bearing potential.
Thursday's agency announcement followed an April ruling by the U.S. District Court in New York that the product had to be made available without restriction, including age.
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.
The FDA has more about this approval.
Posted: June 2013