On the heels of last month’s Supreme Court Dobbs v. Jackson Women’s Health Organization, Deferring abortion policies to individual states, Perrigo, an Irish-based subsidiary of Allergan, has just applied to the FDA for “over-the-counter” status for its oral contraceptives. It’s a wild ride and a potential danger to women’s health.
Existing clinical practice standards require a number of important checks before a healthcare professional prescribes oral contraceptive treatment. Periodic provider visits and follow-ups are essential to get the right dose and to monitor women’s routine health needs. Similarly, in the late 1990s, men visiting their Viagra prescribers for erectile dysfunction were shown to be credited with an increase in early diagnosis of non-erection related health issues such as atherosclerosis. , hypertension and cancer.
It is important to keep in mind that although there are many over-the-counter products, birth control pills can contain progesterone, with or without estrogen. These are not drugs, but synthetically produced hormones. Hormones are particularly effective, powerful, and far-reaching because they reflect chemical signals from the endocrine system and the brain.
No other over-the-counter product contains hormones. Over-the-counter medications are intended for temporary, short-term relief of symptoms, while oral contraceptives are designed as a long-term, chronic medication that can be taken for decades.
Under current guidelines, the following critical prescriber assessments represent the standard of care for initiating or renewing prescriptions for oral contraceptives in order to maintain the existing high public health standards in America. If birth control pills are obtained without a prescription from a medical professional, these assessments will likely be ignored.
The standard of care before prescribing oral contraception is to check blood pressure before starting birth control pills. The hormones in birth control pills can sometimes raise your blood pressure. In extreme cases, the pills can cause secondary hypertension. High blood pressure is a very common disorder in the United States. About 30 to 40 percent of Americans suffer from high blood pressure, and this number is only increasing with rising levels of obesity.
Smoking and potentially even “vaping” is a high risk factor when taking birth control pills. The risk of stroke, blood clot or heart attack increases when a patient smokes and take an oral contraceptive. Providers know how to recommend alternatives to birth control pills for patients who use nicotine or have any other risk factors or family history related to smoking.
Family or personal history of blood clots
Patients at risk for blood clots are also in the high-risk bracket when using oral contraceptives. The birth control pill is known to increase the possibility of blood clots. The estrogen and progestin hormones present in many oral contraceptives cause an increase in clotting factors. Doctors should therefore look for a history of blood clotting as part of the birth control pill review. Patients who have been susceptible to blood clots in the past or who are prone to blood clots should choose an appropriate alternative contraceptive.
Breast cancer screening
Studies from the National Cancer Institute have shown that contraceptives contain progesterone and estrogen which have the ability to increase the risk of or exacerbate existing breast cancer. Patients should get breast screenings before taking birth control pills to detect early disease, as progesterone or estrogen can potentially exacerbate the underlying cancer.
Studies of the University of Houston have shown that contraceptives containing progesterone or estrogen have the ability to increase the risk of existing cervical cancer or exacerbate it. A Pap smear using a cervical cell brush is used to check for cervical cancer. It is also important that patients receive these tests once a year so that if cervical cancer develops, it can be detected and treated early.
Alternatives or reversible options such as a IUD Where subcutaneous implants as alternatives to oral contraceptives will also likely be considered during a prescribing consultation, ensuring that the woman is informed of all her options and can make the best choice for her in consultation with her provider.
The manufacture of over-the-counter contraceptives could lead to increased morbidity and mortality in the form of stroke, heart disease, blood clots and cancer. Additionally, interactions of birth control with existing over-the-counter and prescription medications could lead to an increased incidence of unexpected pregnancies.
Oral contraceptives in particular should remain prescription, and allowing their over-the-counter access would be a barrier to healthy patient visits and preventative medicine testing, which even Planned Parenthood has strongly advocated for many decades in data collection. funds more on its own site.
The FDA is expected to deny Perrigo’s request, but anyone who has followed the Biden White House FDA knows they will most likely approve it for political reasons. Under Biden, the FDA appears to ignore drug safety data as a standard routine issue. Unfortunately, an FDA approval will downgrade the historic standard for monitoring women’s health and fertility.