This week, the FDA ruled to allow girls fifteen and up to buy Plan B emergency contraception without a prescription. Plan B One-Step is a 1.5 mg levonorgestrel, a progestin-only pregnancy prevention pill advised to be taken orally as quickly as possible within 72 hours of unprotected sex. It is not an abortion pill; it will not terminate an existing pregnancy. According to prescribing information, "The most common adverse reactions (=10%) in clinical trials included heavier menstrual bleeding (31%), nausea (14%), lower abdominal pain (13%), fatigue (13%), headache (10%), and dizziness (10%)."
Other significant information:
"Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic. A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of anectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B One-Step. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One-Step."
A search for levonorgestrel on Drugs.com reveals the following:
Do NOT use levonorgestrel if:• you are allergic to any ingredient in levonorgestrel
• you are or suspect that you are pregnant
• you have abnormal vaginal bleeding
• you are taking nevirapine, rifampin, or St. John's wort
• you have had a stroke or history of bleeding of the brain, known or suspected breast cancer, or a blood clotting disorderContact your doctor or health care provider right away if any of these apply to you.
Before using levonorgestrel:
Some medical conditions may interact with levonorgestrel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
• if you are pregnant , planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of ectopic pregnancy or you are premenstrual
• if you have diabetes
Some MEDICINES MAY INTERACT with levonorgestrel. Tell your health care provider if you are taking any other medicines, especially any of the following:• Lamotrigine because its effectiveness is decreased, and when levonorgestrel is stopped, toxic effects, such as nausea, dizziness, and vision problems may occur
• Antifungals (eg, ketoconazole), aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, indinavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), rifampin, rufinamide, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease levonorgestrel's effectiveness
• Anticoagulants (eg, warfarin) because their actions and the risk of their side effects may be increased or decreased by levonorgestrel
• Beta-adrenergic blockers (eg, metoprolol), corticosteroids (eg, prednisone), selegiline, theophylline, or troleandomycin because their actions and the risk of their side effects may be increased by levonorgestrel
• Valproic acid because its effectiveness may be decreased by levonorgestrel
Does this sound like a drug you'd want your 15-year-old to be able to buy off the shelf repeatedly without a prescription? How many 15-year-olds you know would properly assess preconditions that may make them poor candidates for the drug, as well as responsibly monitor and tend to side effects? How many would read the full prescribing information?
Also, if a 15-year-old opts to purchase Plan B in secret, without parental or doctor consent, do you think that same kid would be likely to run to a doctor if uncomfortable symptoms emerge? Would she not be afraid that her parents would find out?
Finally, exactly what message are we sending to kids--and society at large? That there's a quick fix to carelessness? That there's no need to think before you act because the drug companies have it covered?
If this is where we're at--as a society--then we're in big trouble.
The Hillreported that President Obama has no problem with the FDA's ruling:
"The rule that's been put forward by the FDA, [Health] Secretary [Kathleen] Sebelius has reviewed, she's comfortable with it — I'm comfortable with it," Obama said at a press conference in Mexico City.
Obama said he understood that there was "solid scientific evidence" that the contraception was safe for girls of that age.
"I think it's very important that women have control over their healthcare choices and when they are starting a family," Obama said.
I find this fascinating. So 15-year-olds are "women" who should "have control over their healthcare choices"? This, coming from the same man who has repeatedly treated 26-year-olds as kids who should be allowed to stay on their parents' health insurance? So, let me get this straight--a 15-year-old is woman enough to buy Plan B with no prescription or parental/doctor supervision, but a 26-year-old isn't woman enough to take care of her health insurance needs? Pardon me if I'm a little confused. Also pardon me if I don't see the logic, but rather language manipulation to appease political allies.
Any drug that alters a female's hormonal composition is a big deal. I have written about my journey with hormonal concoctions, and I assure you that they are nothing to be taken lightly. While I support access to both traditional hormonal contraceptives and Plan B, I absolutely believe that they should require a prescription/doctor supervision, particularly for minors.
Parents, talk to your kids about these drugs; it might make all the difference. Politicians, be consistent about who you do and don't consider an adult. And pundits, if you're comparing hormonal drugs of any kind to the likes of Tylenol, please take a closer look.