Yourlawyer.com (Topamax News)

Epilepsy Drugs to Carry Suicide Warnings

Wed, 17 Dec 2008 00:00:00 -0800

Epilepsy drugs must now carry warnings about their suicide risks, the Food & Drug Administration (FDA) has announced. The drugs subject to the new warning include those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy. Epilepsy drugs on the list are:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)

Any available generic versions of these drugs will also carry the new epilepsy drugs, the FDA said.

The FDA said its actions were based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo, the agency said.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The FDA added that the biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

In addition to the suicide warning, the FDA is also requiring the drugs' manufacturers to submit f a Risk Evaluation and Mitigation Strategy for each medication , including a Medication Guide for patients. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

Topamax for Migraine Raises Uric Acid Levels, Could Increase Heart Risks

Wed, 10 Sep 2008 00:00:00 -0700

Topamax (topiramate) to treat migraines can increase levels of uric acid in the blood, a new study says. Some research has shown that high uric acid levels can increase the risk for cardiac problems.

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.

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. For this new Topamax study, researchers from Duzce University in Turkey measured blood uric acid, cholesterol, and triglyceride levels in 53 patients with migraine who were receiving Topamax, as well as in 44 matched control subjects not treated with the drug.

Among the patients, average uric acid levels were significantly higher in the migraine patients receiving Topamax. In the Topamax patients for whom pretreatment uric acid levels were known, average uric acid levels were significantly higher after initiation of treatment than in the pretreatment measurements. Average serum triglyceride and total cholesterol levels were also higher in the migraine group, but the differences were not statistically significant.

It is known that excess uric acid in the body can create oxidative stress, which damages body cells and contributes to diseases, including the buildup of artery-clogging plaques. Considering the potential link between abnormally high uric acid levels and cardiovascular complications, "more emphasis should be put on the topiramate-related complications" such as high uric acid levels, the study authors wrote.

In July, British researchers at the Royal Group of Hospitals in Belfast, Northern Ireland, published a study in the journal Neurology that linked Topamax to birth defects, including cleft palate. Of 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. 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.

Topamax Linked to Cleft Palate, Other Birth Defects

Tue, 22 Jul 2008 00:00:00 -0700

A new study has found evidence that children born to epileptic women taking Topamax might be at a higher risk of developing birth defect. Though the study, published this month in the journal "Neurology", looked only at epilepsy patients taking Topamax, the findings may have serious implications for the millions of women of childbearing age who take the drug for migraine prevention.

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.

The study in "Neurology", which was conducted by British researchers at the Royal Group of Hospitals in Belfast, Northern Ireland, involved 203 women who were taking Topamax either alone or in combination with another epilepsy drug when they became pregnant.   Of 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. The birth weights weren't significantly lower than in the normal population.

All epilepsy drugs are known to increase the risk of miscarriage and birth defects, and researchers conducting this study said the Topamax risk was similar to that seen with similar medications. 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.

Women with epilepsy often have no choice but to continue taking drugs like Topamax during pregnancy because epileptic seizures also put fetuses at risk.   Doctors treating such women must weigh the birth defect risks of these drugs against the risk posed by frequent seizures. However, unlike many other epilepsy drugs, Topamax is taken by millions of women of child bearing age for migraines, which means much more of the population could be at risk for birth defects associated with the drug.

In the years since receiving FDA approval for the treatment of migraines, Topamax has become one of the most widely prescribed drugs for the condition, 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

topamax birth defects lawyer cleft palate attorney genital

Tue, 22 Jul 2008 00:00:00 -0700

Topamax Birth Defect Lawyers

Keywords: Topamax Birth Defects Lawyers Cleft Palate Genital

The lawyers and attorneys at our firm are currently offering free consultations to victims of Topamax birth defects. In July 2008, a study was published in the journal "Neurology" that found that babies born to women taking Topamax during pregnancy had an increased risk of being born with birth defects, especially cleft palate and genital birth defects. If a child you know suffers from birth defects that could be related to Topamax, we urge you to contact one of our Topamax birth defect lawyers as soon as possible.

Topamax is an anticonvulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson. Generic versions of Topamax were approved by the Food & Drug Administration (FDA) in 2006. Topamax is approved to treat epilepsy in adults and children, as well as migraine headaches. It is also used off-label to treat bipolar disorder.

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. The Topamax birth defect lawyers at our firm believe that given the evidence of fetal harm in animal studies, the maker of Topamax should have performed more studies to determine its effects on human fetuses, and it should have provided stronger warnings about the possible danger.

In the years since receiving FDA approval for the treatment of migraines, Topamax has become one of the most widely prescribed drugs for the condition, 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. Our Topamax birth defect lawyers believe the widespread use of this drug for migraines by women of child bearing age may have contributed to the occurrence of birth defects in thousands of children.

Topamax Birth Defect Study

The "Neurology" Topamax study was conducted by researchers at the Royal Group of Hospitals in Belfast, Northern Ireland. It 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. 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. Those other drugs included Frisium, Sabril, Epilim or Depakine, Zarontin, Keppra as well as generic drugs carbamazepine, phenobarbitral or phenytoin.

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. The birth weights weren't significantly lower than in the normal population.

Drugs to treat epilepsy are known to increase the chance of miscarriage and birth defects. Still, women suffering from epilepsy need to take the medicines to prevent seizures that can harm the fetus. 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. Because the risk of birth defects associated with valproate is already well known, our Topamax birth defect lawyers believe that doctors who treated pregnant women with a Topamax-valproate combination may be liable for medical negligence.

Although the "Neurology" study 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. 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.

For now, many experts 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. Also, the mother should be informed of the potential risks to her child.

Legal Help for Victims of Topamax Birth Defects

If you or a loved one has given birth to a child who suffers from birth defects that might be the result of Topamax use, you have valuable legal rights. Please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) to discuss your case with an experienced Topamax birth defect lawyer.