First prescription vitamin/mineral supplement for people on the pill

Main Category: Public Health
Article Date: 01 Jan 2004 - 0:00 PDT


Pharmelle Pharmaceutical Company has announced the availability of FEMTABS, the first-ever prescription vitamin mineral supplement designed exclusively for patients on "The Pill". FEMTABS are formulated to address the unique nutritional needs of oral contraceptive (OC) users.

Birth control pills are the most effective form of contraception. While women seem to tolerate oral contraceptives well, it is not unusual for women to experience difficulty adjusting to hormone therapy.

Long term users of oral contraceptives frequently experience side effects consistent with research showing that birth control pills can affect a number of metabolic and nutritional processes.

Over the years, studies have reported drug-nutrient interactions between oral contraceptives and certain vitamins and minerals.

Oral contraceptives have been shown to decrease the levels of key vitamins and minerals and potentially increase the demands of important nutrients.

The use of birth control pills is more common in young women and teenagers, which adds another dimension of uncertainty regarding the nutritional effects of these drugs.

A healthy diet, high in nutrients, is the best protection against any potential nutrition related problems from oral contraceptive use. Unfortunately, many women, and especially adolescents and younger women, are at high risk for improper diet.

Fad diets, fast food, reduced dairy product use combined with increased carbonated soda intake is common with these groups. Many nutritional experts recommend that women on OCs, especially young women, take supportive nutritional supplements.

Given that one quarter of all women who smoke cigarettes also take birth control pills, and over half of those smoke heavily, oral contraceptive patients are at additional risk of deficiencies due to reduced nutrient serum levels from oxidative stress and free radical formation.

A major exogenous source of free radicals is cigarette smoke. Cigarette smoke is a complex mixture of approximately 5,000 chemical compounds, including high concentrations of free radicals and other reactive oxygen species.

To compound the problem, antioxidant deficiency in smokers may be enhanced by their generally lower intake of both supplemental and dietary antioxidants. Several reports provide compelling evidence for a beneficial role of specific antioxidants in the prevention of smoking-related oxidative damage. Note: Women who use oral contraceptives should be strongly advised not to smoke.

New FEMTABS is an Rx only vitamin mineral supplement developed in conjunction with gynecologists for use with patients on oral contraceptives. As reported in studies, combination oral contraceptives containing estrogen can affect the metabolism of several nutrients and result in deficiencies or increased dietary requirements.

'We are pleased to offer physicians a supplement that they can prescribe to their oral contraceptive patients as nutritional insurance to help maintain optimal health,' said Joe Ducharme, PhD, President of Pharmelle.

'Pharmelle is the first pharmaceutical company to support, through professional detailing and education, a product specifically formulated to address the specific nutritional requirements of all birth control pill patient types. With more women going on The Pill and staying on it longer than ever before, there has never been a greater time or need for FEMTABS.'

FEMTABS is designed to provide specific micronutrients that are tied to reported nutritional deficiencies and increased nutrient needs of oral contraceptive patients. FEMTABS is formulated with selective nutrients that address known OC patient concerns.

Vitamin B6 is provided to help prevent deficiencies associated with mood changes/depression that can emerge during early and sustained use of birth control pills. Vitamin B6 can also help minimize amplified PMS that can accompany OC use.

Folic Acid is included to help prevent documented deficiencies noted in OC prescribing information that can result in cervical abnormalities and anemia. Moreover, a major B complex component consisting of B1, B2, B6, B12, Biotin and Folic Acid combined with vitamins C and E and Magnesium help support heart and vascular health.

Key antioxidants help protect the estimated 27% of OC users that smoke from increased oxidative stress and free radical damage. Zinc is also provided for its antioxidant properties and to help reduce increased copper levels tied to oral contraceptive use.

Overall, the critical nutrients and antioxidants supplied by FEMTABS have been shown to help reduce the potential toxicity of oral contraceptives.

'For women to maintain optimal health while on birth control pills, it is necessary to routinely visit a gynecologist for examination and counseling, eat a healthy diet each day, exercise and totally avoid smoking." says Kristin Stickney, Vice President, MediNiche, Inc., the company that developed FEMTABS for Pharmelle. Ms. Stickney adds "FEMTABS fits in nicely with the birth control pill counseling sessions that doctors have with their patients."

FEMTABS are sold to drug wholesalers and pharmacies in bottles of ninety (90) tablets and supplied complimentary to physicians in Patient Starter Kits of three (3) tablets. FEMTABS are dispensed to patients on prescription only.

Pharmelle: Providing Innovative Products for Women's Healthcare

'Pharmelle is committed to maximizing the potential of FEMTABS through the heightened awareness of obstetric and gynecologic care,' said Mr. Ducharme.

'The launch of FEMTABS is consistent with our goal of building a comprehensive line of pharmaceutical and nutraceutical products that add to our growing revenue base. Most important, we are able to leverage our highly-trained and specialized sales force to deliver FEMTABS to ob/gyn's across the country.'

Pharmelle is a specialty pharmaceutical company focused on providing innovative products to the women's healthcare market. The Company's lead product, NATELLE®, prescription prenatal tablets, was introduced in 2002 and has experienced excellent acceptance among physicians.

Pharmelle also markets URELLE, urological antiseptic, for patients with urinary tract infections. The Company intends to pursue additional new products through internal development, partnerships and collaborations with other companies.

CONTACT: Joe Ducharme, Pharmelle Pharmaceutical Company, www.pharmelle.com - (314) 830-4950 or email - jducharme@pharmelle.com.

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