Women, who are exploring new ways to prevent pregnancy, can now look at these options that are coming in the market.
Latest among the vendors is Watson Pharmaceuticals. It has announced the U.S. Food and Drug Administration (FDA) approval of an oral contraceptive (OC) product – claimed to be the first and only low dose oral contraceptive in chewable form.
Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy, the company said Wednesday, Dec. 22.
Among the other OC options, Bayer HealthCare Pharmaceuticals has also announced that the FDA has approved its Beyaz – claimed to be the first and only OC approved to raise folate levels in women who choose an OC for birth control. (Read: Bayer Introduces New Oral Contraceptive)
Recently, FDA also approved ella (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. (Read: FDA Approves ella for Emergency Contraception)
Watson’s new oral contraceptive is an alternative to currently available birth control pills. This pill’s dosing combination and proven 24-day, active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.[ Also Read: What’s the Best Time to Conceive a Child? ]
“The approval of this oral contraceptive further strengthens Watson’s robust and expanding branded Women’s Health portfolio,” said Fred Wilkinson, executive VP, Global Brands.
“We believe this product is an important addition to the oral contraceptive category, and that its characteristics will make it a desirable choice for women.”
The contraceptive product, licensed from a subsidiary of Warner Chilcott plc, will be actively marketed to physicians by Watson’s Global Brands division beginning in the second quarter 2011.[ Also Read: Number of Births to Unmarried Mothers Decline ]
The approval of the oral contraceptive is based on data from a 12-month, Phase 3, multicenter, open-label study that evaluated the safety and efficacy of the product for pregnancy prevention.
Among 1,251 women between the ages of 18 and 35 who completed 12,297 treatment cycles, the pregnancy rate (Pearl Index) in women was 2.01 pregnancies per 100 women-years of treatment.
In addition, women in the clinical trial reported short (mean duration of 3.7 days), predictable periods, with withdrawal bleeding beginning approximately on Day 27 or 28.[ Also Read: Is Masturbation Good for Your Health? ]
The most common adverse reactions (>/= 2%) reported while taking the oral contraceptive in a clinical trial included nausea/vomiting (8.8%), headaches/migraine (7.5%), depression/mood complaints (4.1%), dysmenorrhea (3.9%), acne (3.2%), anxiety symptoms (2.4%), breast pain/tenderness (2.4%), and increased weight (2.3%).
The company informs that nearly 11 million U.S. women use oral contraceptives to prevent pregnancy, and “the Pill” is the most common contraceptive method among women under 30 who practice contraception.
The U.S. oral contraceptive market currently exceeds $4 billion annually and is dominated (86%) by combination (estrogen-progestin) pills.
Watson’s new oral contraceptive is contraindicated in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors or disease, and women who are pregnant.
The product does not protect against sexually transmitted infections (STI) or HIV.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. Women who are over 35 years old who smoke should not use the product, the company warns.
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