FDA Warnings for Birth Control

As a gynecology practice, the Northwest Ohio Center for Urogynecology and Women’s Health, often prescribes medicines that have an important place in the prevention and treatment of conditions such as heavy or painful periods, menopausal symptoms, or osteoporosis.  Medicinal therapies in the form of oral contraceptives, hormone replacement therapy, the IUD, or bone loss prevention medicines are used to significantly help women with the above problems with great successes.

As with any medicine, there is sometimes a risk to benefit ratio regarding side effects or particular dangers of the particular medicine versus the good it does that each healthcare provider should weigh with the patient being counseled. Risks with contraceptive pills or patches most often revolve around blood clots or venous thromboembolism (VTE). Most legitimate studies put that risk at 1 in 10,000 for both contraceptives and hormone replacement. Some forms of contraceptive therapy (Yazmin, Ortho-Evra) may have chemical structures that are minutely more predisposed to clot formation. In regards to the IUD, most risk is regarding insertional perforation or trauma to the uterus which is exceedingly rare according to most studies and can occur to no greater degree than with endometrial biopsy or office hysteroscopy.

When talking of bisphosphonates (Fosamax) for osteoporosis, risks are mainly pointed at gastrointestinal complications like ulcers or an extremely rare condition called osteonecrosis of the jaw. Most patients who suffered these complications had histories of GI disorders or a bone cancer respectively.
The FDA, doing its due diligence, requires that pharmaceutical companies discuss these risks through a “black box” warning to inform the consumer. Unfortunately, even though these medicinal therapies have extremely positive value, a small number of people will have untoward effects as a result of these medicines. Subsequently, class-action litigation has been filed in regards to these products.

Obviously, these products show continued safety overall, otherwise they would have been taken off the market. Regardless, it is up to you as the patient to discuss concerns with your healthcare provider regarding your risks and benefits when being considered a candidate for a prescription of these medicines. Please be prepared to sign or give consent stating that you have discussed the risks and benefits of the medicine before taking it and that the choice to take it is yours.