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Safyral Stroke Lawsuit


The birth control pill Safyral (which is essentially Yasmin plus folate) may cause life-threatening or deadly strokes. Even women who had no previous medical history of blood clots, strokes, or other risk factors have been victims of a stroke.

Safyral is a birth control pill that is manufactured and sold by Bayer. It was approved in the United States by the FDA in December 2010. Safyral contains the same hormonal ingredients as Yasmin birth control pills: 3-mg drospirenone, and 0.03-mg of ethinyl estradiol. The biggest difference is that Safyral also contains a folate B-vitamin.

The added folate in Safyral is intended to reduce the risk of birth defects. Certain birth defects (spina bifida, anencephaly, and more) are far more likely to occur in women who have a folate vitamin deficiency. These birth defects occur in the first few weeks of pregnancy, so it is vital for a pregnant woman to have normal folate levels before the pregnancy occurs.

Though rare, sometimes women taking Safyral do get pregnant. The risk is about 1 women per 100 who take Safyral exactly as directed, at the same time every single day. In reality, many women do not take Safyral exactly as directed, and then the risk of pregnancy is about 9 women per 100. Safyral contains folate to reduce the risk of birth defects in the event that an accidental pregnancy occurs.

Safyral and Strokes

Safyral contains drospirenone, a new type of synthetic progestin. Public sentiment against this ingredient has grown significantly since 2009, when a series of highly critical studies were published linking drospirenone to a higher risk of blood clots compared to other synthetic progestins. The FDA recently announced that the label on Safyral will be updated to include this warning.

When a Safyral blood clot develops, there is a risk that it could cause a deadly ischemic stroke. Blood clots are designed to clog veins, but they are only supposed to develop after an injury occurs, so they can prevent bleeding to death. Safyral increases the risk of developing spontaneous blood clots that form along the walls of veins and arteries located deep within the body. Women who are over 35 years old who smoke have the highest risk of blood clots, but any woman taking Safyral can develop a blood clot.

When a blood clot forms in an artery, it is inside a blood vessel that brings blood directly to a major internal organ. There is a risk that the blood clot will grow so large that parts of it will break off, travel in the bloodstream, and reach a major internal organ.

A blood clot in the brain stops the supply of blood to brain tissue, causing an ischemic stroke. Without blood, brain cells start to die within minutes. If normal circulation is not restored quickly, an ischemic stroke can set off the ischemic cascade. This is a series of biochemical events that occurs when parts of the brain start to die. Otherwise healthy parts of the brain become inflamed, swollen, and damaged. Without sufficient treatment, large sections of the brain can become severely damaged.

When brain cells die, there is no way to repair these cells or replace them. A Safyral stroke can cause severe, permanent brain damage, resulting in lifelong disabilities that are both physical and intellectual. Some stroke victims become comatose and never regain consciousness. Ischemic strokes can also be fatal.

Symptoms of a Safyral Stroke

Stokes are a known side effect of all birth control pills containing progestin, which includes all combination hormonal birth control pills. Although strokes are relatively rare numerically, they have the potential to cause severe, permanent disability or death.

The symptoms of a Safyral stroke may include:

  • Headache: This headache is usually very sudden and severe. If the person is sleeping, the headache may awaken the person from sleep.
  • Changes in consciousness: Dizziness, fainting, feeling suddenly sleepy
  • Cognitive changes: Sudden loss of memory, confusion, change in personality, inability to read, write, understand speech, or talk
  • Loss of motor coordination: Falling, loss of balance, inability to walk, write, swallow, etc.
  • Sensory changes: Changes or loss of senses (such as: blurry vision, abnormal sensation of temperature, sudden hearing loss, strange taste in the mouth
  • Tingling, numbness: This sensation is usually just on one side of the body
  • Muscle weakness: Usually on one side. Part of the face may droop. An arm and/or leg may be suddenly weak.


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