Contraception - Chemical Methods / Hormonal Contraception / Emergency / Morning After Pill

The FDA Again Postpones Decision on Releasing EC/MAP OTC; AAPLOG Statement (26Aug05)

Press Release, Friday, 26 August 05
The Food and Drug Administration (FDA) announced  26Aug05 that it needs public input to decide whether Plan B, the “morning-after pill,” can be sold both without a prescription for those aged 17 and over, yet require a prescription for those 16 and under.

STATEMENT OF THE AMERICAN ASSOCIATION OF PRO-LIFE OBSTETRICIANS AND GYNECOLOGISTS on THE FDA’S  DECISION TO DELAY ACTION ON OVER-THE-COUNTER (OTC) APPROVAL REQUEST FOR EMERGENCY CONTRACEPTION  27 August 2005…

The requested FDA approval of Over The Counter Emergency Contraception for women 17 years of age and older would be bad medical practice.

Further, it would be a disaster for many women–especially for teenagers, who are more prone to risk-taking behavior, and more susceptible to sexually transmitted diseases (STDs/STIs).

And certainly 17 year olds would procure it for 13 year olds, so the OTC age limit, in practice, is unworkable.

EC simply is not as effective as advertised.  The pubic is told that if taken right after unprotected midcycle intercourse,  EC will prevent 88% of expected pregnancies.  This is, at best, a very poor half-truth.

Recent large studies in Scotland (See A Glaiser et al, Advanced Provision of Emergency Contraception Does Not Reduce Abortion Rates, Contraception 2004;69:361-366, at www.contraceptionjournal.org)  and San Francisco (See TR Raine et al, Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs, JAMA, 2005; 293:54-62, at www.jama.com)
demonstrate this  point.

Women in these studies were given the EC to take home and put on the nightstand for immediate availability after unprotected sex.  But they had the same abortion rates and the same unintended pregnancy rates as a control group of women (who had to procure their prescription from a physician after their “emergency” arose.)

This medication is a dangerous deception, since it encourages women to trust it for contraception, but fails to reliably deliver on that promise. (Or, as the Scottish research article concluded,  “advanced provision of EC probably prevents some pregnancies for some women some of the time“.)

Additional serious medical down-sides to OTC availability are equally problematic.  Many women would be using EC without accompanying medical follow-up for sexually transmitted disease testing.

Chlamydia, an STD already seen in epidemic proportions among teens and college age women, would go undiagnosed and untreated, scarring fallopian tubes, and resulting in future infertility for many.

HPV, a widespread and very communicable viral STD, is associated with the development of cervical cancer, and untreated HPV would put many women at future risk for this deadly cancer.

The British government warned its  doctors last year that pregnancies resulting from “failed” use of EC had a tripled rate of ectopic pregnancy.  With no doctor involvement, this diagnosis would be missed, or at best, delayed.  Undiagnosed, untreated ectopic
pregnancy is a life threatening condition. 

Doubtless, OTC Emergency Contraception would become a popular “date rape” drug.  Boy friends and predatory males would find this drug a very helpful tool to “persuade” women to comply with their demands.  Women under 17 years of age will be as “at risk” for this type of forced sex as those 17 and over.

However you look at it, Over-The-Counter “Emergency Contraception” is bad medicine for women.  The FDA has asked for input.

We strongly urge parents and doctors alike to express their feelings to the FDA .

The American Association of Pro-Life Obstetricians and Gynecologists represents over 2000 Obstetricians and Gynecologists, and is a Special Interest Group of the American College of Obstetricians and Gynecologists.

Dr. Lester Crawford
Commissioner
FDA CDER
5600 Fishers Lane
Rockville, MD 20852

Resources:  http://www.physiciansforlife.org/major-medical-concerns-regarding-ec-apfli-statement-805/ FDA phone number: 1-888-INFO-FDA (1-888-463-6332)

 

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A group of pro-life doctors and OBGYNs said the FDA’s decision to not yet allow sales of the Plan B drug without a prescription was appropriate.

The American Association of Pro-Life Obstetricians and Gynecologists said approval of the morning after pill for over the counter sales would be “bad medicine” and “a disaster for many women, especially teenagers.” The medical group echoed concerns Crawford laid out when he announced the indefinite postponement, saying that there is no way to enforce the requirement that teenagers under the age of 16 still be required to obtain the sometimes abortion-causing drugs with a prescription. [LifeNews.com, 30Aug05]
Facts about “Plan B”
With the pending decision by the Food and Drug Administration concerning over the counter dispensing of the Morning After Pill, it is important to remember some facts about this product:
Physicians recommend that women with certain medical conditions should not take the morning-after pill without physician consultation if they have certain medical conditions including: blood sugar diseases, like diabetes, certain types of cancer, liver disease, menstrual problems, migraine headaches and certain allergies.
There is a long list of side effects including: nausea, abdominal pain, fatigue, headache, vomiting and diarrhea. It is impossible to properly label it for consumers because of the many possible dangers and side effects of the drug.
Since Plan B has been available over-the-counter in Britain, there has been a massive increase in sexually, transmitted diseases. Between 1995 and 2000, diagnosis of genital chlamydia went up 77%, gonorrhea by 57% and syphilis by 56%.
Dr. Trevor Stammers wrote, “These indices reflect the outcome of years of unprecedented availability of contraception among young people….”
There are no studies of this drug’s effect on adolescents or the developing teenager and …selling Plan B over-the-counter removes them from their physician’s care.  [24Aug05, http://www.ccbama.com/audio/CCBAMA-082405.mp3; Christian Coalition of Alabama 29Aug05]