In March 2011, the U.S. Food and Drug Administration (FDA) and Johnson & Johnson updated warning labels on the anticonvulsant medication Topamax to include new information about the risk of serious birth defects if the drug is taken by women who are pregnant.
Topamax, also available as the generic topiramate, is now listed by the FDA as a Pregnancy Category D medication, or a drug that shows positive evidence of human fetal risk.
According to FDA data, more than 32 million Topamax prescriptions have been filled since 2007. Unfortunately, millions of women may have taken Topamax during pregnancy in the 15 years that Topamax was listed as a Pregnancy Category C medication, without knowing Erectol the associated risks.
Topamax Linked to Oral Birth Defects
If taken during pregnancy, Topamax has been found to increase the risk of birth defects and oral deformities in the developing fetus, including:
- Cleft palate
- Cleft lip
The risk of these birth defects is especially high if the medication is taken during the first trimester of pregnancy, when a woman may not yet realize that she is pregnant.
Filing a Topamax Lawsuit
Patients who have taken Topamax during pregnancy may be eligible to receive compensation to cover medical expenses, pain and suffering resulting from medication-related birth defects.
Topamax Side Effects
Topamax and its generic form topiramate have been shown to increase the risk of certain side effects that can be serious and debilitating. Topamax acts on nerve cells in the brain to reduce abnormal brain activity, and the medication can cross the placenta barrier and affect a developing fetus if the medication is taken by women who are pregnant.
Can Topamax cause birth defects?
If taken by women who are pregnant, Topamax has been shown to cause birth defects such as cleft palate and cleft lip in a developing fetus. If a fetus is exposed to Topamax while in the womb, especially during the first trimester, the medication may interfere with the fusion process of the lip and palate.
According to data from the North American Antiepileptic Drug Pregnancy Registry, an estimated 1.4 percent of babies exposed to Topamax during the first trimester were born with birth defects such as cleft palate and cleft lip, as compared with 0.38 to 0.55 percent of infants who were exposed to other types of antiepileptic drugs.
What serious side effects are associated with Topamax?
Topamax may increase the risk of the following serious side effects:
- Decreased sweating
- Increased body temperature or fever
- Glaucoma
- Increased eye pressure
- Vision loss
- Suicidal thoughts
- Depression
- Metabolic acidosis
- Hyperventilation
- Abnormal heartbeat
- Confusion
- Speech or language difficulties
- Kidney stones
Decreased Sweating, Increased Body Temperature or Fever
Patients have reported decreased sweating as a side effect of treatment with Topamax. The medication has been known to affect the body's ability to produce sweat and adequately cool itself, causing increased body temperature (fever) which may be dangerous to patients in warm climates or those who overheat easily.
Glaucoma, Increased Eye Pressure, Vision Loss
Glaucoma, a term referring to a group of eye conditions that cause damage to the optic nerve, has been linked to treatment with Topamax. Though rare, patients have reported symptoms of glaucoma following treatment with Topamax, noting severe eye pain, gradual vision loss, increased eye pressure, blurred vision, halos around lights and reddening of the eye.
Glaucoma is the second leading cause of blindness, and the condition often progresses gradually.
Suicidal Thoughts, Depression
Treatment with Topamax has been linked to an increased risk of suicidal thoughts and depression. Studies have found that up to 13 percent of patients who take Topamax experience depression. Patients are strongly advised to speak with their doctor if they experience any symptoms of depression including feelings of sadness, irritability, reduced sex drive, feelings of worthlessness, insomnia or excessive sleeping and thoughts of death or suicide, among others.
Metabolic Acidosis, Hyperventilation, Abnormal Heartbeat
Metabolic acidosis is a condition that occurs when the body creates too much acid, or when the kidneys fail to remove enough acid from the body. Use of Topamax may increase the risk of this potentially life-threatening condition, affecting – to some extent – approximately one third of adults and two thirds of children who take the medication.
There are three different types of metabolic acidosis, including:
- Lactic acidosis
- Hyperchloremic acidosis
- Diabetic acidosis
Symptoms of metabolic acidosis include hyperventilation, abnormal heartbeat, loss of appetite, fatigue or changes in a patient's level of alertness.
Confusion
Warnings associated with Topamax treatment note that the way a patient thinks may be altered due to use of the medication. Patients may experience confusion, difficulty concentrating, sleepiness, depression and memory problems.
Speech or Language Difficulties
Speech difficulties are also associated with the use of Topamax and may include stuttering and slurred speech. Patients may also struggle with finding the right words to say and mixing up words when they speak.
Kidney Stones
An increased risk of kidney stones is associated with the use of Topamax, with approximately one in 50 adults reporting the condition following treatment with Topamax. Kidney stones are located inside the kidneys and are composed of mineral and acid salts. They are hard and small and often quite painful to pass. The prevalence of kidney stones in patients treated with Topamax is higher in men and those who have previously experienced kidney stones.
What Topamax side effects are the most common?
Common side effects of Topamax include:
- Tingling of the arms and/or legs
- Nausea
- Dizziness
- Nervousness
- Memory problems or confusion
- Difficulty concentrating
- Loss of appetite
- Fatigue and extreme sleepiness
- Weight loss
