A Product Label for Pregnancy

 

I just learned that the European version of the FDA is holding a three-day meeting this week to review the safety of the most commonly used contraceptives in the world: combined estrogen/progestin birth control pills (full disclosure: my husband works for a pharmaceutical company that sells this type of contraceptive). The French government recently announced that it is not going to pay for these oral contraceptives and want some taken off the market because of a perceived increased risk of venous thrombosis, blood clots that can travel to the lungs.

In addition, the FDA recently required manufacturers of these drugs to add a “black box” warning about the increased risk. However, two well-designed studies found no increased risk between these third- and fourth-generation contraceptives and earlier generation birth control pills.^1,2

The reality is that all forms of estrogen-containing contraception, whether pill, patch, or ring, carry a risk of blood clots. Generally, 6.29 women out of 10,000 women using these forms will experience a clot versus 3.01 in nonusers.³ The risk is highest, however, in women over 35 who smoke or have hypertension.

Plus, those supposedly “safer” birth control pills have side effects that cause women to stop taking them, such as acne, breakthrough bleeding and hirsutism. I don’t know about you, but I prefer not to see my face break out as if I were a teenager, have a period that goes on all month, or find hair growing in places where hair should never grow. Neither do most women, who will likely take their chances with condoms (or other less-effective approaches) if they don’t have access to these types of oral contraceptives.

What we have here, people, is a “pill scare.” A 2010 statement from the Society of Obstetricians and Gynaecologists of Canada put it best: “Recent contradictory evidence and the ensuing media coverage of the venous thromboembolism risk attributed to the progestin component of certain newer oral contraceptive products have led to fear and confusion about the safety of oral contraceptives in general and drospirenone-containing oral contraceptives in particular. ‘Pill scares’ of this nature have occurred in the past, with panic stopping of the pill, increased rates of unplanned pregnancy, and no subsequent decrease in venous thromboembolism rates.”

The problem? You are far more likely to get a blood clot during pregnancy (29/10,000) or in the immediate postpartum period (as high as 300–400/10,000). Venous thrombosis is also the leading cause of maternal mortality in the United States. And that’s just one potentially life-threatening consequence of pregnancy.

Yet most women don’t know this because we don’t require product labels for pregnancy like we do for prescription drugs. So, in the interest of fairness, let’s  imagine what such a label might look like.

——————–Indications and Usage———————-

Indicated for women of childbearing age who wish to begin a family.

——————–Dosage and Administration——————

Sexual intercourse just prior to ovulation.

——————–Dosage Forms and Strengths—————-

One sperm and one egg with the requisite DNA content

——————–Contraindications—————————–

• Age <18
• Heavy drinker or drug user
• Smoking
• Obesity
• Prior history of venous thrombosis

 

——————–Warnings and Precautions——————–

• Life changing
• Incredibly expensive
• Venous thrombosis
• Pulmonary embolism
• Stroke
• Massive bleeding
• Infection
• Diabetes
• Death

——————–Adverse Reactions—————————–

Most common (≥10%): headache, nausea, vomiting, fatigue, swelling, hemorrhoids, constipation, heartburn, hypertension, back pain, insomnia, irritability, mood swings, strange cravings, disfiguring marks upon the skin (may be permanent), incontinence (may be permanent)

———————Drug Interactions——————————-

May trigger adverse reaction with any over-the-counter or prescription drug.

———————-Use in Specific Populations——————-

• Not recommended for women ≥50 and older
• Women with diabetes, hypertension, obesity, kidney problems, autoimmune diseases, and heart disease may experience significant complications.

Now, you tell me: which puts women at greater risk: preventing a pregnancy with easy-to-use oral contraceptives or an unplanned pregnancy?

Now tell that to the European Medicines Agency and the FDA.