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First Chewable Contraceptive Approved
Nov. 14, 2003 -- The FDA today approved the first chewable birth control pill.
Ovcon 35, an oral, spearmint-flavored contraceptive tablet that can be chewed and swallowed, provides one more alternative to the many types of oral contraceptives currently on the market. Ovcon 35 contains a progestin (norethindrone) and an estrogen (ethinyl estradiol) found in products that are already available.
The chewable birth control pill may be swallowed whole or chewed and swallowed. If the pill is chewed and then swallowed, the woman should drink a full glass (8 ounces) of liquid immediately afterwards so that the full dose of medication reaches the stomach and no residue is left in the mouth.
Ovcon 35 is available only in a 28-day regimen. Each package contains 21 round, white tablets, with norethindrone and ethinyl estradiol followed by seven reminder green (inactive) tablets to complete a 4-week-cycle.
Like other birth control pills, Ovcon 35 is effective for prevention of pregnancy when used as directed. The risks of using this product are similar to those of all birth control pills and include an increased risk of blood clots, heart attack, and stroke -- especially in smokers over age 35.
SOURCE: News release, FDA.
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