FDA to Consider Plan B Going Over-the-Counter

Will you soon be able to buy the morning after pill at your favorite drug store?

Barr Laboratories, Inc. the makers of the Plan B(R)levonorgestrel, also known as the "morning after pill," announced today that two U.S. Food and Drug Administration (FDA) Advisory Committees have recommended that the drug, available now only by prescription, be permitted to be sold over the counter(OTC).

The FDA will now consider the recommendation, represented by a vote of 23 to 4 in favor of Plan B. If approved by the FDA, as an OTC product for use as an emergency contraceptive, Plan B would be sold in single use packages that would deter it from being used as a routine form of birth control. The final decision is expected to be made in February of 2004.

Pregnancy rates using the morning after pill

Effectiveness declines as the time between intercourse and the start of treatment begins.

• Taken in the first 24 hours after sex Plan B can prevent up to 95 percent of expected pregnancies.
  
  
• Taken within 72 hours of a single act of unprotected intercourse, Plan B has been shown to reduce the pregnancy rate by 89 percent; however this is significantly less effective than consistent use of birth control.
  
  
• Plan B is not effective if the patient is already pregnant.
  
  
• Plan B does not protect against sexually transmitted diseases and is not intended to be used in place of correct and consistent usage of regular contraceptives.

Side effects may include nausea, cramps, fatigue, headaches, and changes in menstruation. Severe abdominal pain may indicate an ectopic or tubal pregnancy.

Call your health care professional immediately if you experience severe abdominal pain after using the morning after pill.

One of the barriers currently facing patients wishing to use this method of birth control is the need for a prescription, and usually a visit to the doctors office. By releasing Plan B over the counter, many health professionals believe a more timely treatment will result in a more effective treatment.

Who should not use Plan B?

Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over periods of time, and are contraindicated in some conditions. It is not known whether these conditions apply to the Plan B regimine. However, Plan B is not recommended for use in the following conditions:

• known or suspected pregnancy
  
  
• hypersensitivity to any component of the product
  
  
• undiagnosed abnormal genital bleeding

Source: Barr Laboratories, Inc.