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.

6 Responses to “A Product Label for Pregnancy”

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  2. Natasha Das

    Love the way you put it, Debra. Weighing the risks and benefits is extremely important, especially in a country like mine that has a population of over 1.21 billion. Maternal mortality is so high here (20% of all maternal mortality occurs in India) that using an easy oral pill is much better. It is very difficult to convince women for permanent contraception even if they have had over 4 children. VTE risk with OCP use is a fact that cannot be denied. But here, many more women die each year because of an unwanted pregnancy or a pregnancy gone bad than because of OCP use.

  3. Dan

    Reminds me of nothing so much as the “guns for home defense” argument. Which is the greater risk to an average household: having a gun in the house OR being killed by armed intruders.

  4. Antonín Cuc

    I think that is among the doctors were not good atmosphere for free discussion. While the terrified pulmonary specialists are concentrated patients who experienced embolism and a high percentage of young healthy women without high blood pressure after the diagnosis of contraceptive use and gynecologists prescribe flesh meanwhile merrily on this contraception, because subjects with impaired even know they were passed and are also driven bonuses pharmaceutical companies – and some people who had already died of embolism, nothing pathologist or survivors of their previous withhold contraception. Many large “Medical research on the safety of contraceptive medicines’ finances or implements pharmaceutical company and outwardly it may not even be idetifikovatelné for consumers. Socially serious health investigations should primarily organize independent healthcare organizations operating in famous respectable organisation garanted the patient protection or by the government. My participation in this discussion is conditional on my personal experience as a state safety inspec tor dangerous products and regards the fact that my daughter has been in 35 years hit embolism after contraception.

  5. Wayne G. Fischer, PhD

    So, let me see if I’ve understood: Women using estrogen-containing contraceptives more than double their chance of getting blood clots that can travel to the lungs, but that’s just a “pill scare” tactic…? “Don’t look at that, look over here at the “risks” of pregnancy!”

    [Oh, and women, pay no attention to “the International Agency for Research on Cancer (IARC), a division of WHO, reported in a monograph released on July 29, 2005 that oral contraceptives were highly carcinogenic, thus placing them into the category of Group I carcinogens (like lead and benzene), known to cause cancer in humans.”]

    • Debra Gordon

      Oral contraceptives are actually protective for several types of cancer, including ovarian. Every drug –even aspirin–has risks. The question is weighing the risks against the benefits. If women do not want to get pregnant, then oral contraceptives are an excellent option, work very very well, and the risk of VTE is extremely low compared to the risk of VTE if they were to get pregnant. All I’m saying is that the agencies are not evaluating the risks and benefits appropriately.

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