Advancements in birth control give women more options
March 28, 2007
Several FDA approvals during the past few months are providing more birth control options for women and offering protection against viruses that can cause cervical cancer and genital warts.
Two of the approvals involve oral contraceptives, while a third is for the HPV (human papillomavirus) vaccine Gardasil.
Approved by the federal Food and Drug Administration on May 25, Seasonique is an oral contraceptive that reduces the number of menstrual periods from 13 each year to four and reduces the risk of problems such as breakthrough bleeding with its low-dose estrogen in place of the placebos that are common in other types of oral contraceptives. With Seasonique, patients take active tablets containing the progestin levonorgestrel (.15 mg) and the estrogen ethinyl estradiol (.03mg) for 84 consecutive days, followed by seven days of .01 mg of ethinyl estradiol.
The majority of oral contraceptives are based on a 21-day regimen of active pills followed by seven days of placebos.
Seasonique manufacturer Barr Laboratories Inc. in Woodcliff Lake, Bergen County, follows in the mold of its predecessor, Seasonale, an extended-regimen oral contraceptive which gained FDA approval in September 2003. Although Seasonale also allows only four menstrual cycles per year, its 84 active tablets are followed by seven days of inactive tablets.
Even before the introduction of Seasonique and Seasonale, women who wanted the convenience of delaying periods would do so by taking all of the active pills in their 28-day prescriptions, said Dr. Christina Chao of PennCare-Pine-lands OB/GYN Associates in Medford and Mount Holly.
The active pills prevent a wo-man’s body from building up the lining of the uterus, eliminating the need for the lining to shed, therefore no period results. With the conventional 28-day regimen, periods occur while taking the placebo tablets, and with Seasonique, while taking the final seven pills.
“In regular birth control pills, a lot of people take the whole pack of regular pills and not take the placebo,” said Chao.
Although the method works, patients might find Seasonique is a better choice for several reasons.
“If your prescription plan pays for a monthly pill, then you are short,” she said.
In addition, she said, “Having that estrogen all the time will prevent PMS (including mood swings), migraines (and menstrual headaches) and will decrease breakthrough bleeding (bleeding between periods).”
It also helps prevent painful periods (cramps) and endometriosis (tissue which lines the uterus found growing outside the uterus), said Chao.
Even with Seasonale, more breakthrough bleeding may occur during the first month of use, said Chao.
She said two new 24-day, active pill regimens include YAZ and Loestrin 24 Fe, which averages periods of less than three days. YAZ and Loestrin 24 Fe also contain “very low-dose estrogen” and because “you’re only off the (active) pill four days,” less breakthrough bleeding occurs, said Chao.
Serious risks associated with using oral contraceptives include blood clots, stroke and heart attack. Smokers, especially those over age 35, also face increased risks of cardiovascular problems, according to Dr. Robert Siefring, a member of the OB/GYN staff at Cooper University Hospital in Camden. The hormones in the contraceptives also can stimulate growth of uterine fibroid tumors in women who have them, he said. In addition, women who have undiagnosed genital bleeding or who have breast cancer should not take oral contraceptives, said Siefring.
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Siefring, who said he does not typically prescribe the extended-regimen contraceptives, “especially the Seasonale, which has more breakthrough bleeding,” acknowledged that convenience makes them attractive options.
Another factor to consider is the cost of contraceptive pills, which “is approaching $50 per month,” he said.
“I’m putting in more progestin IUDs — they’re good for five years,” said Siefring, and their cost $300, breaks down to $60 per year.
“They are very effective and eliminate the problem of the patient forgetting to take the pill or losing the pill,” he said.
Another product, which had been available as a prescription since 1999, earned FDA approval on Aug. 24 for over-the-counter use for women 18 and older. (Prescriptions are still required for patients 17 and younger.) Plan B (by Duramed Pharmaceuticals of Cincinnati, a subsidiary of Barr Pharmaceuticals), also known as emergency contraception or “morning after” pills, consists of two tablets containing the progestin levonorgestrel, a synthetic hormone which must be taken within 72 hours of having unprotected sex.
According to information on the FDA Web site, Plan B works to prevent pregnancy by stopping the release of an egg from the ovary. It also may prevent fertilization of the egg, or prevent a fertilized egg from attaching to the womb. Plan B will not work if a fertilized egg has been implanted prior to taking the emergency pills.
“It’s not as effective as birth control,” said Chao, but, “if they do get pregnant anyhow, there’s no effect to the fetus.”
“Plan B has been a tremendous addition to our ability to treat a patient,” said Siefring. “We’ve had post-coital contraception before. It was a combination of pills, but the problem with that was that we’d have to call in scripts and it typically was associated with a lot of nausea and vomiting. You would take a significant amount of hormones,” he said.
“With Plan B, a protestin-only treatment, it doesn’t contain the estrogen. You still get some nausea, headache, abdominal pain and breast tenderness,” said Siefring.
Chao added that irregular bleeding may occur a week after taking the pills.
Yet, the over-the-counter availability of Plan B creates “less anxiety for the patient,” who may be embarrassed about calling a physician in the middle of the night to explain why she needs the emergency contraception, said Siefring.
E-Mail: LINDA WONDOL
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