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Health Care Reform                                                                                                                                                                  




FDA toys with Over-the-Counter Sales of Emergency Contraception Medication


by Sophia Barkat




M. Sara Rosenthal, PhD, wrote in her book, "The Gynecological Sourcebook": "Currently, one in eight girls aged fifteen to nineteen gets pregnant each year—78 percent of these pregnancies are unintended. Even today, with all the contraception education available, 36 percent of teenaged girls report they do not use contraception. Preventing pregnancy is still a high priority!" (See http://my.webmd.com/content)


Yet, in the last week of January 2005, the US Food and Drug Administration postponed a decision on whether to allow over-the-counter sales of Emergency Contraception or "Morning After" drugs in the US.


The Feminist Majority Foundation, in a recent press release, expressed its outrage, saying that the FDA once again gave in to right-wing pressure in deciding to delay its decision on over-the-counter status for the emergency contraceptive, Plan B for women ages 16 and older.


"The FDA is playing a dangerous game in allowing right-wing politics to trump science," said Eleanor Smeal, President of the Feminist Majority Foundation. "These stall tactics are just hurting women, especially young women. The FDA has had more than enough time to realize what public health experts and its own advisory panels already know – that EC is a safe, effective, and critical tool in preventing unwanted pregnancy. Ironically, by opposing a product that would reduce the number of abortions in the United States, the right wing is working against its own professed goals. Clearly, the right wing is not only against abortion, but also contraception. Emergency contraception is the moral property of women. Women seeking to avoid an unintended pregnancy need quick access to safe, effective and affordable contraception and back-up birth control 24 hours a day, 7 days a week," said Beth Jordan, MD, the medical director for the Feminist Majority Foundation. "The science is clear, the need is great, and yet with this disastrous decision, the FDA continues to play politics with women’s lives, placing women at needless risk and in harm’s way." (See http://www.feminist.org)


FMF claims that more than 70 medical organizations support EC's purchase over-the-counter. (See http://www.feministcampus.org)


So, why is the FDA dilly dallying the decision? Were these drugs not safe enough to be taken without a prescription? What ECs are available in the US? Let’s have a look.





ECs in the US


According to the Emergency Contraception Website operated by the Office of Population Research at Princeton University and the Association of Reproductive Health Professionals, and funded by the William and Flora Hewlett Foundation. (See http://ec.princeton.edu/)

"There are two types of Emergency Contraceptive pills.

One type uses hormones that are the same type and dose as hormones used in some kinds of ordinary birth control pills. These hormones are called estrogen and progestin (combined ECPs). In many countries (but not the United States), these pills are especially packaged and labeled for emergency use. But several other brands packaged for ongoing contraception can be used as well. About 50% of women who use this type get nauseated and 20% vomit. Use of this pill cuts the chance of pregnancy by 75%. This statement does not mean that 25% of women using ECPs will become pregnant. Rather, if 100 women had unprotected intercourse once during the second or third week of their cycle, about 8 would become pregnant; following treatment with ECPs, only 2 would become pregnant: a 75% reduction.

The other type of emergency contraceptive pill contains only the hormone called progestin (progestin-only ECPs). In many countries this type is specially packaged and labeled for use for emergency contraception; the brand name in the United States is Plan B. It is more effective than the first type, and the risk of nausea and vomiting is also lower. If the same 100 women used Plan B, only 1 would get pregnant: an 89% reduction."


The site lists these drugs and doses for Emergency Contraception in United States of America:

Dedicated Products / Progestin Only
 
Drug name: Plan B
Dosage: Take 2 pills within 120 hours after unprotected sex



Oral Contraceptives used for EC / Progestin Only

Drug name: Ovrette
Dosage: Take 40 pills within 120 hours after unprotected sex



Oral Contraceptives used for EC / Progestin-Estrogen Combined

Drug names: Ogestrel, Ovral
Dosage: in 28-day packs, only the first 21 pills can be used; Take 2 pills within 120 hours after unprotected sex and take 2 more pills 12 hours later:


Drug name: Cryselle, Levlen, Levora, Lo/Ovral, Low-Ogestrel, Nordette, Portia, Seasonale
Dosage: Take 4 pills within 120 hours after unprotected sex and take 4 more pills 12 hours later:


Drug name: Alesse, Aviane, Lessina, Levlite, Lutera
Dosage: Take 5 pills within 120 hours after unprotected sex and take 5 more pills 12 hours later:



Safety


The two chemicals used in ECs, thus introduced, are Estrogen and Progestin. According to M. Sara Rosenthal, PhD, the side-effects of these chemicals are: (See http://my.webmd.com/content/Article)



Estrogen-Related Side Effects

Too High Dose: splotchy face, chronic nasal congestion, flu-like symptoms, hay fever/allergies, urinary tract infections, bloating, dizziness, edema, (water retention), headaches, irritability, leg cramps, nausea/vomiting, vision changes, weight gain, cervical changes, breast cysts, dysmenorrhea (painful periods), heavy flow, and clotting. increase in breast size, excessive vaginal discharge, uterine enlargement, uterine fibroid growth, capillary fragility, blood clots, and related disorders spidery veins on the chest area.


Too Low Dose: bleeding/spotting days 1–9, continuous bleeding/spotting, flow decrease, pelvic relaxation symptoms, vaginitis atrophic.



Progestin-Related Side Effects

Too High Dose: appetite increase, depression, fatigue, hypoglycemia symptoms, weight gain, hypertension, leg veins dilated, cervicitis, flow length decrease, yeast infections, acne, jaundice, hirsutism, libido increase, libido decrease, oily skin and scalp, rash and pruritus, edema.


Too Low Dose: bleeding/spotting days 10–21, delayed withdrawal bleeding, dysmenorrhea, heavy flow and clots, bloating, dizziness, edema, headache, irritability, leg cramps, nausea/vomiting, vision changes, weight gain, amenorrhea.



Progestin-Estrogen Side Effects

Combining Progestin and Estrogen, as in the Combined ESPs or OCs -- as termed in the article -- can have the following effects, according to M. Sara Rosenthal, PhD:


  • Blood Clots/Heart Attacks

"Blood clots (a.k.a. venous thromboembolisms) are the most common serious risk linked to OCs. Clots can form in the brain and heart, which translates into heart attacks and strokes. Smokers on OCs are more likely to have a heart attack than are non-Pill users who smoke. Because OCs increase the chance of having a heart attack, women on the Pill who don't smoke are more likely to develop heart disease than are non-OC users who don't smoke. They are also more likely to have a stroke than non-OC users. Women on OCs are also more likely to rupture a blood vessel in the brain than are non-OC users and are more likely to develop a blood clot in the leg or arm, which can mean amputation. They are more likely to suffer a pulmonary embolus, and the risk of blood clots in the lungs is higher. A woman planning to have major surgery will need to discontinue taking OCs about six weeks prior to the surgery. Studies looking at the newest formulations of OCs found that cardiovascular risks in nonsmokers were far less than with older formulations, and experts today conclude that risk of heart attack in the newest formulations is very small. It's now believed that OCs do not increase the risk of heart attack for healthy nonsmokers who do not have other risk factors for heart disease." (See http://my.webmd.com/content/)


It further states that, "If you have a history of thrombophlebitis, pulmonary emboli, or other cardiovascular diseases, you should not be encouraged to take OCs. Your risk of blood clots also increases if you smoke, don't exercise, are overweight, are over fifty, are hypertensive or diabetic, or have high cholesterol. (See http://my.webmd.com/content/)



  • Breast Cancer

According to M. Sara Rosenthal, PhD, "The official warnings in your Pill packets will tell you that if you have a mother or sister with a history of breast cancer, a pill containing estrogen can put you at greater risk for developing breast cancer prior to menopause. The warnings will also tell you that if you've been on OCs longer than eight years and/or began them early, you are considered to be statistically more at risk for breast cancer. One U.S. study found that women under thirty-five who used an estrogen-containing pill for more than ten years increased their risk of breast cancer by about 70 percent compared to women who never took OCs. There are also studies that showed no difference between women on the Pill for ten years compared to non-Pill users, as well as studies that showed a decreased risk in Pill users after the age of forty-five (which is potentially very good news). Since less than 2 percent of all breast cancers are diagnosed in women under thirty-five anyway, the study showing an increased risk really shouldn't rattle you all that much because, in the final analysis, you're looking at a very small number. Instead of one in five hundred women developing breast cancer before thirty-five, that statistic increases it to one in three hundred." (See http://my.webmd.com/content)




When not to Use


According to Rosenthal, the size of a woman matters in determining what is the correct dosage for her. (See http://my.webmd.com/content/)  More so, a doctors physical is important to ascertain if she has the following problems, which would only get worse with combined ESPs or OCs: (http://my.webmd.com/content/)


    * blood clots in the legs or eyes
    * cardiovascular problems
    * heart disease or coronary heart disease
    * breast cancer
    * liver tumors
    * abnormal vaginal bleeding
    * migraine headaches
    * high blood pressure
    * diabetes
    * active gallbladder disease
    * sickle cell disease
    * any major injury to your leg(s) that required a cast (check with your doctor)
    * epilepsy (use with caution)
    * planned elective surgery within a month (use with caution)





Effects on Menopausal Women & Long-term Effects


It should be noted that in menopausal women, the Combined ESPs or OCs have shown higher levels of breast cancer. The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) reports, "it has stopped early a major clinical trial of the risks and benefits of combined estrogen and progestin in healthy menopausal women due to an increased risk of invasive breast cancer. The large multi-center trial, a component of the Women's Health Initiative (WHI), also found increases in coronary heart disease, stroke, and pulmonary embolism in study participants on estrogen plus progestin compared to women taking placebo pills. There were noteworthy benefits of estrogen plus progestin, including fewer cases of hip fractures and colon cancer, but on balance the harm was greater than the benefit. The study, which was scheduled to run until 2005, was stopped after an average follow-up of 5.2 years." (See http://www.nlm.nih.gov/) It is not what dosages were used in these studies.


The report interviews Jacques Rossouw, M.D., acting director of the WHI who had this to say about the drugs: "Women with a uterus who are currently taking estrogen plus progestin should have a serious talk with their doctor to see if they should continue it. If they are taking this hormone combination for short-term relief of symptoms, it may be reasonable to continue since the benefits are likely to outweigh the risks. Longer term use or use for disease prevention must be re-evaluated given the multiple adverse effects noted in WHI."


It should be noted that about 6 million women in the U.S. are taking estrogen plus progestin for a variety of reasons, including symptom relief, because their doctors advised it, or for long-term health.




So, Over-the-Counter or Not?


As mentioned above, Combined ESPs – estrogen and progestin Emergency Contraception pills – are most effective in ruling out pregnancies than are plain Progestin ECs. But Combined ESPs are more dangerous. Indeed, the FDA would be right to regulate access to such pills, and they have. The debate at hand is not to make Combined ESPs over-the-counter or not, however.


It is about allowing Progestin based ESPs to be over-the-counter. We have just seen how much safer they are in comparison to combined counterparts.


The Feminist Majority Foundation rightfully points out, that the FDA is pandering to the Right-Wing "pro-life" lobby.  Citing that Plan B – a Progestin based ESP – "is safer than taking aspirin or anti-histamines; it meets all of the FDA's requirements for over-the-counter status; and is 95 percent effective in preventing pregnancy if taken in the first 24 hours after unprotected intercourse" that the dilly dallying is uncalled for. Greater access to Plan B could markedly reduce the number of abortions in the United States dramatically.


"Ironically, by opposing a product that would reduce the number of abortions in the United States, the right wing is working against its own professed goals," said Smeal. "Clearly, the right wing is not only against abortion, but also contraception."





More Reference:

http://www.fda.gov/fdac/features/2003/203_estrogen.html

http://www.fda.gov/cder/drug/infopage/estrogens_progestins/



                                                                                                                                             


About the Author(s):
 

See under Our Contributors to find out about the Author(s) of this article.






 


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