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By Robert Longley, About.com Guide to US Government Info since 1997

FDA Approves First Chewable Contraceptive

Wednesday November 19, 2003
The Food and Drug Administration (FDA) has approved for sale the first chewable oral contraceptive for women. Ovcon 35, is a spearmint flavored tablet that can be chewed and swallowed over a 28-day period. Risks, says the FDA, are similar to those of all birth control pills. Click the “Read more” link below for details.

The FDA has approved Ovcon 35, an oral, spearmint-flavored contraceptive tablet that can be chewed and swallowed. This new version of Ovcon 35, indicated for the prevention of pregnancy, 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 marketed.

The directions for use tell women that the 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. The labeling also carries the warning that cigarette smoking by women, especially over age 35 increases the risk of serious cardiovascular side effects from use of combination hormonal contraceptives.

The product is manufactured by Bristol Myers Squibb Company, Princeton, N.J., and will be marketed by Warner Chilcott, Inc., Rockaway, N.J. [FDA press release]

Also See: Women's Heart Attack Symptoms Different from Men's

Comments

December 6, 2007 at 11:19 pm
(1) Carole the Contraceptive Reviewer says:

Women have taken this medication for several years now and this linkhttp://www.askapatient.com/viewrating.asp?drug=17716&name=OVCON-35 indicates a low rating of satisfaction from women who have tried it.

The comments from patients are worth browsing though- an individual may identify with some of them.

If you take ANY oral contraceptive, it helps to really KNOW your body’s changing status as you move through your menstrual cycle- many women confuse ‘normal’ bloating, moodiness and other PM symptoms with what they think are side effects of the ‘pill’.

Yes, of course there are side effects for some women, all our bodies react to medications differently (even vitamins and minerals!)but in order to manage our birth control successfully and safely, we need to be given as much information as possible as to the pros and cons of all types.

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