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Judge orders Plan B pill be available OTC to all ages, children at risk

In Uncategorized on April 5, 2013 at 1:03 PM

Judge orders Plan B pill be available OTC to all ages, children at risk

A Federal judge this morning has ruled the Plan B pill to be sold over the counter and available to any female of any age.

The Plan B pill has essentially been taken out of the medical professionals hands and placed it into the hands of a teen, pre teen or anyone of menstrual age without any guidelines or restraints for it’s purchase with possible unlimited use.

In other words, easy access to a powerful birth control method, capable of terminating fertilization of an egg by sperm and subjecting young children to possibly multiple exposures resulting in moderate to high doses of female hormone ingestion without parental or adult approval or oversight.

These drug combinations have been studied for about 40 years and have a variety of negative outcomes and many side effects.

In recent years the use of contraceptives have been discouraged because new research has revealed that long term use of hormonal contraceptives have been linked to breast and uterine cancers as well as an increase in blood clots.

The Plan B pill is being billed as an emergency contraceptive just in case Plan A fails such as in the case of a broken condom or unprotected sex.

Unlike the RU 486 which terminates a pregnancy,  Plan B actually prevents the females egg from being fertilized with the male sperm if taken within 5 days or 120 of intercourse.

Emergency contraceptives contain the hormones estrogen and progestin (levonorgestrel), either separately or in combination

Drugs used for this purpose are called emergency contraceptive pills, post-coital pills, or morning after pills.

Plan B works like other birth control pills to prevent pregnancy. Plan B acts primarily by stopping the release of an egg from the ovary (ovulation). It may prevent the union of sperm and egg (fertilization). If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation). If a fertilized egg is implanted prior to taking Plan B, Plan B will not work.

The child or adult will take this pill within the recommended 3 days of intercourse and the progressive infusion of female hormones will hopefully keep the recipient from becoming pregnant.

According to FDA,in the event of pregnancy going to term after taking the Plan B pill, the pregnancy could possibly result in an ectopic pregnancy, an emergency medical condition. 

This means a pregnancy originating somewhere in the body besides the uterus, most often in a fallopian tube. 

This medical condition is life threatening and can lead to hemorrhaging and or death.

In a  2003 study done by the FDA of 585 recipients of Plan B, only 29 females 16 and under were studied leading to their conclusion that the Plan B drug was not safe for over the counter distribution and it was concluded that not enough children were studied to deem it safe for OTC distribution.

Now the 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 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

Again, big pharma, big money lobbyists with the blessings of many medical associations to include the AMA have stepped up and convinced a judge to order that the Plan B drug be available over the counter immediately. So guess what, the drug is now available over the counter. The FDA siting it does not necessarily  have to follow it’s own recommendations.

I believe this is a very dangerous game we are playing again with the bodies of our children. 

I don’t believe that a powerful combination of hormones easily available to a child, without any medical oversight, knowledge of an adult or the child’s parents consent is in the best interest of our children.

This is dangerous and promotes underage, unprotected sex as being acceptable and ok. It leaves the future health in the hands of a person that is not necessarily capable of determining what is safe or not. 

This leaves the impression that when  a child has unprotected sex they cant just ante up ten or so dollars for a Plan B package and wallah, I’m  safe and mom and dad will never know.

Hopefully, someone will step in and either overturn this judges order or challenge it in some way and stop this easy access to possibly harmful hormones.

We, as parents, must stay informed and understand that big government and big pharmaceuticals do not always have your childs best interest at heart. 

Sadly, its about the money.

Source of info:

http://m.upi.com/story/UPI-2181365169206/

http://m.plannedparenthood.org/mt/www.plannedparenthood.org/health-topics/emergency-contraception-morning-after-pill-4363.asp

http://www.womenshealth.org/a/Plan_B_Morning_After_Emergecy_Contraceptive.htm

FDA does not approve Plan B for OTC dispensing:  Deemed not safe

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109795.htm

Non-approval letter from FDA:

http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109793.pdf

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