On April 22,2009 the FDA announced that the government will not appeal a decision by a federal court to allow Duramed Research to make Plan B (the morning after pill, Levonorgestrel) available to women, 17 years and older, without a prescription. Duramed was given the go ahead, upon submission and approval of an appropriate application, to actively market Plan B for over the counter use (without a prescription) to women age 17 and above.
Emotional and moral issues aside, the focus is blurred concerning the physical adverse effects and unseen dangers that the approval of unprescribed access to those under 18 (without parental consent) could harbor.
The package insert, required and included in every box, lists the data (as provided to the FDA) as follows:
Action of Plan B (How Does The Morning After Pill Actually Work?)
Levonorgestrel (Plan B) works primarily in two ways:
- Prevents ovulation or fertilization by altering the transport of sperm and or ova (egg).
- Plan B inhibits the implantation of a fertilized egg by altering the endometrium itself.
Efficacy Of Plan B (How Effective Is Plan B?)
- A study (double blind, controlled) comparing 1,955 women taking Plan B versus Yuzpe regimen was presented and summarized in the product informational packet. Plan B was found to be at least as effective as the Yuzpe regimen in the prevention of pregnancy.
- After one act of intercourse, pregnancy rate without contraception (expected to be at approximately 8%) was lowered to approximately 1% in those on Plan B.
- Interestingly, pregnancy rates in all races in both groups were similar with the exception of Chinese women who had a higher pregnancy rate in both regimens. The reason for the higher rates in currently unknown.
Proper Dosing Of Plan B
One 0.75 mg tablet is taken within 72 hours post intercourse and is followed by a second tablet 12 hours later.
Plan B Adverse Events
Adverse events (in general and in addition to the study group below) may include:
- Irregular menstrual bleeding patterns
- Spotting
- Increased chance of ectopic pregnancy
- Deterioration in glucose tolderance with increase in plasma insulin
- Effectiveness could possibly be reduced by phenytoin and carbamazepine (anticonvulsants), barbiturates and rifampin (antituberculosis medication).
- Nursing mothers could possibly pass small amounts of progestin through breast milk.
The package insert also reports adverse event data in the study group as follows (reported if occurring in 5% (> or = to) of patients studied) :
- Nausea - 23.1 %
- Abdominal Pain - 17.6%
- Fatigue - 16.9%
- Headache - 16.8%
- Heavier Menstrual Bleeding - 13.8%
- Lighter Menstrual Bleeding - 12.5%
- Dizziness - 11.2%
- Breast Tenderness - 10.7%
- Other Complaints (not itemized in insert) - 9.7%
- Vomiting - 5.6%
- Diarrhea - 5.0%
Plan B Concerns with Under-18 Use
Active opponents of the new approval have raised the following concerns regarding unmonitored use of Plan B in the under-18 age group:
- Plan B may be misused as routine emergency contraception in lieu of a regular birth control method and may impact long term health in this population.
- Teens may obtain Plan B for underage (in this instance, under the age of 17) peers, raising legal as well as safety concerns.
- Dosing errors - Concern has been raised that those in this age group may make dosing errors resulting in both overdosing and underdosing mistakes and consequences.
- Use in this age group may result in failure to seek proper medical care, advice or follow up as needed.
Additional Plan B Data Needed
Further studies are needed regarding the following:
- Drug to drug interaction (no formal studies have been reported to date).
- Overdosing (no formal data has been reported to date).
Sources:
FDA Drug Information Page - Plan B
Plan B Duramed Research Pharmaceutical
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