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Could Topamax Increase Heart Risks?

Topamax use has been linked to decreases in body weight and kidney stones, but no studies have looked at its affect on uric acid levels until now. Now, a new Topamax study, conducted by researchers from Duzce University in Turkey, has found that people taking the drug for migraine treatment had higher levels of uric acid in their blood - a condition that could increase their risk for heart problems.

The study looked at 53 patients taking Topamax and 44 who did not. Those using the drug had significantly more uric acid in their blood than patients not using Topamax. In the Topamax patients for whom pretreatment uric acid levels were known, average uric acid levels were significantly higher after initiation of Topamax treatment than in the pretreatment measurements.

It is known that excess uric acid in the body can create oxidative stress, which contributes to diseases, including the buildup of artery-clogging plaques. Such plaques are a major risk factor for heart problems.

Topamax For Epilepsy and Migraines

Topamax is an anticonvulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson. It was originally approved in 1997 as a treatment for epilepsy, but in 2004, the Food & Drug Administration (FDA) approved Topamax for the prevention of migraines. In children, Topamax is also approved for the treatment of Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delay).

Topamax is also used off-label as a treatment for bipolar disorder. Topamax has been investigated as a treatment for obesity and binge eating, as well as alcoholism. In 2004, the FDA approved generic versions of Topamax.

In the treatment of epilepsy, Topamax has been used by about 4 million people worldwide. Topamax can be used alone, or with other antiepileptic medications. Topamax is usually taken twice a day for epilepsy.

In the years since receiving FDA approval for the treatment of migraines, Ortho-McNeil has promoted it heavily. Topamax is touted as a way to stop migraines from occurring, and it is taken daily to prevent their occurrence.

Topamax has become one of the most widely prescribed drugs for migraines, which affects almost 30 million Americans. Women are three times more likely to suffer from migraines than men; women in their childbearing years are particularly vulnerable.

The most common Topamax side effects include a change in taste and feelings of pins and needles in the head and extremities. Less common side effects include cognitive deficiency (particularly word-finding difficulty); difficulty understanding or understanding concepts; grogginess; lethargy; kidney stones, impairment of fine motor skills; vision abnormality and transient or permanent vision loss; severe eye pain; weight loss; breast pain; abdominal pain; intense sweating; menstrual disorder; taste changes; pharyngitis; sinusitis; diplopia; rash; leukopenia; fatigue; dizziness; insomnia; anxiety; depression; paresthesia; diarrhea; nausea; dyspepsia; constipation; dry mouth; and dysmenorrhea.

In July 2008, researchers in Britain shed new light on another possible Topamax side effect - birth defects. A study conducted at the Royal Group of Hospitals in Belfast, Northern Ireland, looked at 203 epileptic women who became pregnant while taking Topamax. The chances that women in the study would give birth to a child with a birth defect increased by as much as 14-fold. The risk for birth defects was especially high in women who took Topamax in combination with another epilepsy drug, valproate.

Of the 178 live births that occurred, three babies whose mothers took Topamax alone and 13 whose mothers took Topamax along with other anti-epilepsy drugs had major birth defects. Four of the babies had cleft palates or cleft lips, which was 11 times higher than would be expected among women not taking epilepsy medication. Four male babies had genital birth defects, with two of these classified as major birth defects. Minor defects included a hole above the buttocks, a flattened head, toe webbing, clicky hips and immature hip joints.

It has long been known that drugs that treat epilepsy are linked to an increased risk of birth defects. The researchers said that the birth defect rate associated with Topamax in their study was in line with those of other anti-seizure drugs, though a larger study is needed to draw definitive conclusions. However, more birth defects occurred in women taking Topamax along with the drug valproate, or valproic acid, than in women taking other epilepsy drugs or other Topamax drug combinations.

The American Academy of Neurology recommends that women with epilepsy considering pregnancy take only one drug, if possible, to control seizures and that they take epilepsy drugs in the lowest effective dosages.

“More research needs to be done to confirm these results, especially since it was a small study,” said John Craig, of the Royal Group of Hospitals in Belfast, Northern Ireland. Craig said risk of birth defects may be different for women taking the drugs to control migraine but they should still be monitored carefully.

“But these results should also get the attention of women with migraine and their doctors, since topiramate is also used for preventing migraine, which is an even more common condition that also occurs frequently in women of childbearing age,” Craig said.

Women of child-bearing age who use Topamax for treatment of epilepsy face a dilemma if they wish to become pregnant, or if they do become pregnant. While Topamax does appear to increase the risk of birth defects, epileptic seizures also increase the risk of fetal harm. In this situation, the risk of birth defects from Topamax must be weighed against the risk to a baby posed by seizures.

The use of Topamax for migraines, however, far outpaces the use of the drug for epilepsy. Migraines are far more common among women than men, and they are most common in women of childbearing age. The shear numbers of women taking Topamax indicates that thousands of unborn babies could be at risk for developing birth defects from this drug.

The researchers involved in the British Topamax study have called for more investigation of this issue. In the meantime, epileptic women taking Topamax should speak with their doctors if they are planning a pregnancy, or become pregnant. Woman using Topamax for migraines should consider an alternative treatment if they plan to conceive.

Topamax Birth Defects

Keywords: Topamax Birth Defects Cleft Palate Male Genitalia Migraine

Topamax (topiramate ), a drug used to treat epilepsy and migraine headaches, has been linked to birth defects in a small study conducted by researchers at the Royal Group of Hospitals in Belfast, Northern Ireland. The study looked at 203 women who became pregnant while taking Topamax for the treatment of epilepsy and found that the risk of birth defects increased by as much as 14-fold.

Topamax, made by Ortho-McNeil Neurologics, a division of Johnson & Johnson, was originally approved to treat epilepsy in adults and children. In 2004, the approved uses of Topamax were expanded to include the prevention of migraine headaches. Generic versions of Topamax were approved by the Food & Drug Administration (FDA) in 2006. Topamax is also used off-label to treat bipolar disorder.

Although the study, published in the July 22 issue of the journal of “Neurology”, was small, it was the first to link Topamax to birth defects in humans, and confirmed earlier animal studies that showed evidence of fetal harm. The researchers who conducted the study said that the connection between Topamax and birth defects warrants further study.

Of the 178 live births that occurred among women in the study, three babies whose mothers took Topamax alone and 13 whose mothers took Topamax along with other anti-epilepsy drugs had major birth defects. Those other drugs included Frisium, Sabril, Epilim or Depakine, Zarontin, Keppra as well as generic drugs carbamazepine, phenobarbitral or phenytoin.

The rate at which the birth defects occurred were 11 to 14 times higher than one would expect among women not taking the drug, the researchers said in a news release from the American Academy of Neurology. The birth defects seen in the Topamax study included:

· Cleft Palate - a condition in which the two plates of the skull that form the hard palate (roof of the mouth) are not completely joined. The soft palate is in these cases cleft as well. In most cases, cleft lip is also present. Cleft palate occurs in about one in 700 live births worldwide.

· Defects of the male genitalia

· Hole above the buttocks

· Flattened head

· Toe webbing

· Clicky hips and immature hip joints

Four of the babies had cleft palates or cleft lips, which was 11 times higher than would be expected among women not taking epilepsy medication. Four male babies had genital birth defects, with two of these classified as major birth defects.

Drugs to treat epilepsy are known to increase the chance of miscarriage and birth defects. The researchers said that the birth defect rate associated with Topamax in their study was in line with those of other anti-seizure drugs, though a larger study is needed to draw definitive conclusions.

However, more birth defects occurred in women taking Topamax along with the drug valproate, or valproic acid, than in women taking other epilepsy drugs or other Topamax drug combinations. Valproate is sold as Depakote by Abbott Laboratories and as Depakine by Sanofi- Aventis.

Previous research has shown that valproate is associated with an increased risk of birth defects such as heart defects and spina bifida. Valproate carries a box warning on its label regarding this risks. The FDA recommends that valproate be avoided during pregnancy.

Maintaining effective epilepsy treatment during pregnancy is crucial because seizures may cause harm to the fetus. Researchers suggest that those epileptic women who depend on this drug to control their convulsive seizures should continue it. However, if they are taking it for migraine prevention, the drug should be discontinued before conception.

When it was approved, Topamax received a pregnancy category C classification from the FDA, which means the drug hasn’t been studied in pregnant women, though it appears to cause harm to the fetus in animal studies. The drug caused birth defects, miscarriages, and decreased fetal weight in rabbits, rats and mice, according to the U.S. prescribing information.

Three major databases currently track birth defects among babies born to women taking epilepsy drugs, but only one has so far provided information on Topamax. When the other databases report, the extent of Topamax’s association with birth defects should become clearer.

The lead researcher on the Topamax study said that a pregnant woman using this treatment for either epilepsy or migraines should be informed of the potential risks to her child. Others are advocating that Topamax use in women who plan on conceiving should be restricted to those in whom the drug is definitely needed for seizure control or other indications.

Women with who are currently taking Topamax who are considering becoming pregnant, or who are already pregnant, should speak with their doctors about this drug. For epileptic patients, doctors will have to weigh the birth defect risks of Topamax against the risks epileptic seizures pose to developing fetuses.