Safyral Side Effects

The birth control pill Safyral contains drospirenone, a newly-developed type of synthetic progestin. The FDA now warns that women using drospirenone may be 75% more likely to suffer blood clots, which can then cause heart attack, ischemic stroke, pulmonary embolism, and more.

FDA Updates Safyral Safety Warnings

April 2012 — The FDA has recently announced that it will be updating the drug safety information for all birth control pills containing drospirenone. In a statement, they said: “The FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” The FDA will be updating the drug safety information to warn about the increased risk of blood clots associated with drospirenone.

What is Safyral?

Safyral is a once-daily hormonal birth control pill. It is very similar to Yasmin, but Safyral contains folic acid, a B-vitamin dietary supplement. Safyral was invented by the pharmaceutical company Bayer HealthCare Pharmaceuticals, Inc. The U.S. Food and Drug Administration (FDA) approved Safyral for sale in the U.S. in December 2010.

Safyral contains the following active ingredients:

3 milligrams of drospirenone, a “fourth generation” synthetic progestin, which is a female reproductive hormone
0.03 milligrams of ethinyl estradiol, which is a synthetic type of estrogen, another female reproductive hormone
0.451 milligrams of folate metabolite (levomefolate calcium), which is a dietary supplement that is intended to prevent neural tube birth defects

Safyral is basically Yasmin plus folic acid. The FDA recommends that women who are of childbearing age should take a folic acid supplement every day to prevent certain types of severe birth defects (such as spina bifida) just in case pregnancy occurs. Researchers have discovered that most neural tube birth defects are caused because the mother is deficient in folic acid. Because these defects occur during the first couple weeks of pregnancy, it is important to take this supplement, even if you are not intending to become pregnant.

Safyral and Drospirenone

Safyral and Yasmin both contain drospirenone. This controversial ingredient has been linked to a 75% increased risk of blood clots compared to older generations of synthetic progestin in other birth control pills. In real numbers, the absolute increased risk is still very small — instead of 4-6 per 10,000, the risk with drospirenone increases to approximately 10 per 10,000. The problem is that when the FDA approved drospirenone birth control (Yaz and Yasmin), tens of millions of women switched to these new contraceptives. As a result, there were tens of thousands of extra cases of blood clots — some of which caused death.

Why did so many women switch to the new birth control pills? Though they were no more effective at preventing pregnancy and had a slightly higher risk of life-threatening blood clots, many women probably believed that they were superior to older birth control pills. This may have been due to the fact that Bayer ran a $270 million advertising campaign in the mid-2000s. You may remember women popping balloons labeled “bloating” and “acne.” The FDA later sent Bayer a warning letter, calling the advertisements “misleading.” The FDA was concerned that the ads “failed to communicate any risk information,” and misled women into believing that the pills could enhance quality-of-life by treating all acne and PMS. Bayer later ran a corrective advertising campaign, but by that time, most women using birth control had switched to a pill containing drospirenone.

Safyral and Blood Clots

The problem with drospirenone is that, for some women, it causes potassium levels to increase too much. This increases the risk of deep vein thrombosis (DVT), a Safyral side effect in which blood clots form. The blood clots are most likely to form in the veins inside the lower legs, but they may also form in the thighs, pelvis, upper arms, or other parts of the body.

If you knew that Safyral could increase the risk of blood clots, you may not have realized that blood clots are an extremely dangerous side effect of a medication. When a blood clot forms, it occasionally breaks loose from its original location and begins to float in the bloodstream (known as an embolism). The embolism travels in the body until it becomes too large to flow through a blood vessel, and then it will become trapped in this blood vessel and stop all forward blood flow.

The lack of blood flow starves organ tissue of oxygenated blood, which can cause the tissue to die. If it becomes trapped in the lungs, this is called a pulmonary embolism. Blood clots can also easily become trapped in the heart (causing a heart attack) or brain (causing an ischemic stroke).