THE SHANE FOUNDATION POSITION ON THE SAFETY
OF HORMONE-BASED CONTRACEPTIVES
For the majority of women, these products are safe, but for a significant percentage, they are risky – even highly risky. The question is – how do you know if you may be at risk?
Since the 1970’s it has been well known that combined hormone-based contraceptives, (made with the progestin levonorgestrel and ethinyl estradiol) increased the level of risk for blood clots. But newer versions, containing the synthetic progestin, (“diospirenone” and other versions) have been shown to increase this risk exponentially. (These risks include deep vein thrombosis, pulmonary embolism, heart attack and stroke)
In Europe, the European Medicines Agency (EMA) in 2001 recommended second-generation COCs, i.e. levonorgestrel containing COCs, monophasic, as the first choice because of the data indicating a lower risk of VTE in this group of users compared with users of third-generation pills (COC containing desogestrel or gestodene). This statement was confirmed in 2013 [European Medicines Agency, 2013] where it was concluded that also drospirenone containing COC implied a higher VTE risk.
There was a strong effort to have these newer drugs removed from the market but the FDA decided that “improved warnings” were sufficient.
Unfortunately, many women don’t read these warnings/disclaimers and the lists of potentially serious side effects. Fewer still, understand them. This problem is exacerbated by a lack of explanation and warnings from prescribing doctors and the mass-marketing of these drugs as common consumer-products driven by the advertising power of gigantic, international pharmaceutical manufacturers.
The official position of the ACOG, (American College of Obstetricians and Gynecologists) is that, since the risk of blood clots in pregnancy far exceeds the risk posed by these contraceptives, they are “statistically, worth the risk”. (See “Conclusions” - “Risk of Venous Thromboembolism Among Users of Drospirenone-Containing Oral Contraceptive Pills” ACOG “Committee Opinion” 11/2012)
Form The Shane Foundation perspective, this translates to mean that the lives of some women are statistically expendable because of a greater possible statistical risk to others.
Additionally, as Shane’s story exemplifies, it also means that anyone with risk factors which increases their risk of blood clots from the hormones in contraceptives, is at an even greater risk during pregnancy and postpartum.
Because these high-risk drugs remain on the market, and because manufacturers are constantly altering the formulations, devices of delivery and names under which they are marketed, this issue is relegated to a case of “buyer beware”.
Therefore, EACH WOMAN MUST BECOME HER OWN FIRST LINE OF DEFENSE!
This means each woman must know her risks and know the danger symptoms.
Risk factors:
Symptoms to watch out for:
If you have any of these which don’t stop, call your health care provider.
If escalating, call 911.
Before using any contraceptive products containing hormones, speak with your doctor.
OF HORMONE-BASED CONTRACEPTIVES
For the majority of women, these products are safe, but for a significant percentage, they are risky – even highly risky. The question is – how do you know if you may be at risk?
Since the 1970’s it has been well known that combined hormone-based contraceptives, (made with the progestin levonorgestrel and ethinyl estradiol) increased the level of risk for blood clots. But newer versions, containing the synthetic progestin, (“diospirenone” and other versions) have been shown to increase this risk exponentially. (These risks include deep vein thrombosis, pulmonary embolism, heart attack and stroke)
In Europe, the European Medicines Agency (EMA) in 2001 recommended second-generation COCs, i.e. levonorgestrel containing COCs, monophasic, as the first choice because of the data indicating a lower risk of VTE in this group of users compared with users of third-generation pills (COC containing desogestrel or gestodene). This statement was confirmed in 2013 [European Medicines Agency, 2013] where it was concluded that also drospirenone containing COC implied a higher VTE risk.
There was a strong effort to have these newer drugs removed from the market but the FDA decided that “improved warnings” were sufficient.
Unfortunately, many women don’t read these warnings/disclaimers and the lists of potentially serious side effects. Fewer still, understand them. This problem is exacerbated by a lack of explanation and warnings from prescribing doctors and the mass-marketing of these drugs as common consumer-products driven by the advertising power of gigantic, international pharmaceutical manufacturers.
The official position of the ACOG, (American College of Obstetricians and Gynecologists) is that, since the risk of blood clots in pregnancy far exceeds the risk posed by these contraceptives, they are “statistically, worth the risk”. (See “Conclusions” - “Risk of Venous Thromboembolism Among Users of Drospirenone-Containing Oral Contraceptive Pills” ACOG “Committee Opinion” 11/2012)
Form The Shane Foundation perspective, this translates to mean that the lives of some women are statistically expendable because of a greater possible statistical risk to others.
Additionally, as Shane’s story exemplifies, it also means that anyone with risk factors which increases their risk of blood clots from the hormones in contraceptives, is at an even greater risk during pregnancy and postpartum.
Because these high-risk drugs remain on the market, and because manufacturers are constantly altering the formulations, devices of delivery and names under which they are marketed, this issue is relegated to a case of “buyer beware”.
Therefore, EACH WOMAN MUST BECOME HER OWN FIRST LINE OF DEFENSE!
This means each woman must know her risks and know the danger symptoms.
Risk factors:
- Obesity
- Smoking
- Previous blood clot
- Blood clotting disorders, (thrombophilias or APS)
- Are over 35
- Family history of blood clots
- Sitting still for too long, (long plane flights, required bed-rest)
- C-section surgery
- Autoimmune disease such as lupus
- Diabetes
- Headaches
- High blood pressure, triglycerides or cholesterol
- Any combination of these
Symptoms to watch out for:
- Persistent shortness of breath
- Swelling in your thigh, leg, or arm
- Pain, tenderness, redness, discoloration, warm to the touch of leg or arm
- Persistent, increasing headache or sudden severe headache
- Onset of vision problems
- Irregular heartbeat, “heaviness” or chest pain
- Fainting or feeling anxious
- Coughing up blood
- Any combination of these
If you have any of these which don’t stop, call your health care provider.
If escalating, call 911.
Before using any contraceptive products containing hormones, speak with your doctor.
