In contrast, Plan B can only be used to help prevent pregnancy if taken within 5 days of sex. It works by delaying or stopping ovulation. The risks you and your partner face depend on when the condom broke and the type of intercourse you were having. There are steps you can take to….
But remember, whatever happens, you aren't alone and you have options. You can and should take Plan B and other EC pills as…. Read on to learn what to expect. When it comes to emergency contraception, there can be a lot of confusion. But there are many other facts about…. Health Conditions Discover Plan Connect. And 13 Other Questions, Answered. The short answer?
Why do some people confuse the two? Quick comparison chart. Plan B Medication abortion What is it? Medication that prevents pregnancy soon after sex Medication that ends an early pregnancy Can it be used to prevent a pregnancy? Yes Yes Can it be used to end a pregnancy? No Yes How does it work? Delays or prevents the release of an egg from the ovary Stops a pregnancy from growing and forces it from the uterus How long does it take?
Works for several days 4 to 5 hours How effective is it? About as safe as taking the birth control pill Safer than carrying a pregnancy to term Does it have side effects?
Yes — menstrual cycle irregularities, spotting, nausea, and vomiting Yes — cramping, bleeding, nausea, vomiting, and diarrhea.
How does Plan B work? Is it normal to bleed after? How effective is it? How does the abortion pill work? Will taking Plan B affect your future fertility? Plan B should be taken within 72 hours of unprotected sex, for a higher efficacy rate. Levonorgestrel works to halt pregnancy before it takes place.
Plan B is most effective if taken within 72 hours. However, if ovulation has already occurred, the medication might not be able to prevent pregnancy. Lauren Sharkey is a U.
She has also written a book profiling young female activists across the globe and is currently building a community of such resisters. Catch her on Twitter. If you've had unprotected sex or experienced condom failure, there are a number of things you can do to prevent pregnancy and protect against STIs and…. You can and should take Plan B and other EC pills as…. Plan B can affect the length of your menstrual cycle, meaning that your next period may come later or earlier than normal.
We break down your options for birth control and how to get them, plus highlight some of the best free or low-cost providers in all 50 states and…. The best birth control method for you depends on effectiveness, cost, side effects, and more. Learn about popular birth control forms, like the shot…. Read on to learn what to expect. When it comes to emergency contraception, there can be a lot of confusion. Natural Cycles and other fertility awareness apps can be an effective way to prevent pregnancy.
Our review explains what you need to know. There are alternatives. Body conditioning exercises are full-body moves that work to strengthen your muscles and cardiovascular health. Health Conditions Discover Plan Connect. What exactly is it? Who can take it? How effective is it? What if you take it after 72 hours? FDA staff reviewed the scientific data contained in the application which included among other data, an actual use study and a label comprehension study. On December 16, , we held a public advisory committee meeting with a panel of medical and scientific experts from outside the federal government.
The members of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health, met jointly to consider the safety and effectiveness data of nonprescription use of Plan B. Although the joint committee recommended to FDA that this product be sold without a prescription, some members of the committee, including the Chair, raised questions concerning whether the actual use data were generalizable to the overall population of nonprescription users, chiefly because of inadequate sampling of younger age groups.
Following the advisory committee meeting, FDA requested additional information from the sponsor pertaining to adolescent use. The sponsor submitted this additional information to FDA in support of their pending application to change Plan B from a prescription to an over-the-counter product. This additional information was extensive enough to qualify as a major amendment to the NDA.
Now FDA has completed its review of the supplemental application and concluded that the application could not be approved at this time because 1 adequate data were not provided to support a conclusion that young adolescent women can safely use Plan B for emergency contraception without the professional supervision of a licensed practitioner and 2 a proposal from the sponsor to change the requested indication to allow for marketing of Plan B as a prescription-only product for women under 16 years of age and a nonprescription product for women 16 years and older was incomplete and inadequate for a full review.
Therefore, FDA concluded that the application was not approvable. The recommendations of FDA advisory committees are advisory in nature and the Agency is not bound to follow their recommendations.
FDA makes a decision on whether a product should be approved after evaluating all data and considering the recommendations of the advisory committee. The agency issued a Not Approvable letter because the supplemental application did not meet the criteria for approval in that it did not demonstrate that Plan B could be used safely by young adolescent women for emergency contraception without the professional supervision of a licensed practitioner.
The issuance of a Not Approvable letter does not mean that a supplemental application cannot be approved. The Not Approvable letter describes what the applicant would need to do to obtain approval for the supplemental application. In this case, the applicant would have to either provide additional data demonstrating that Plan B can be used safely by women under 16 years of age without the professional supervision of a practitioner licensed by law to administer the drug or provide additional support for the revised indication to allow for marketing Plan B as prescription-only for women under the age of 16 and as nonprescription for women 16 years of age and older.
Not Approvable Letter. Yes, there was a difference of opinion within CDER. The scientific interchange of ideas is widely encouraged during the review process to ensure a thorough vetting of the issues. However, ultimately, a final decision must be made based on the evaluation of the data, taking into account all of the views expressed.
The Not Approvable letter to the sponsor outlines what the sponsor must do to obtain approval of the supplemental application. Wide availability of safe and effective contraceptives is important to public health.
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