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Migraine Guidelines: What Works, What Doesn't

Posted 23 Apr 2012 by Drugs.com

MONDAY, April 23 – Dozens of medications are available to prevent debilitating migraine headaches, but most migraine sufferers don't use them, a new study finds. "Approximately 40 percent of people with migraines need preventive treatment, and only about one-third of them are actually getting it," said Dr. Stephen D. Silberstein, co-author of new guidelines developed by the American Academy of Neurology and the American Headache Society. The drugs include prescription, over-the-counter and herbal medications. Which will work best "depends on the patient," said Silberstein, director of the Jefferson Headache Center at Thomas Jefferson University in Philadelphia. The guidelines, published in the April 24 issue of Neurology, were scheduled for presentation at the academy's annual meeting in New Orleans, April 21 to 28. Dr. Brian M. Grosberg, director of the Montefiore Headache Center in ... Read more

Prescription Meds Can Put on Unwanted Pounds

Posted 2 Mar 2012 by Drugs.com

FRIDAY, March 2 – Medications taken by millions of Americans for mood disorders, high blood pressure, diabetes and other chronic conditions can have an unhealthy side effect: weight gain. While other choices exist for some types of drugs, adjusting medications is not simply a matter of switching, said Ryan Roux, chief pharmacy officer with the Harris County Hospital District, in Houston. In the late 1990s, Dr. Lawrence Cheskin conducted early research on prescription medicines and obesity. "Some medicines make an early, noticeable difference, causing patients to become ravenously hungry, while changes are subtle for others. A few months taking them and you've gained 10 pounds," said Cheskin, now director of the Johns Hopkins Weight Management Center, in Baltimore. To help increase awareness, Roux and his pharmacist group have compiled a list of "weight-promoting" and "weight-neutral or ... Read more

Fetal Exposure to Epilepsy Drug Might Raise Autism Risk: Study

Posted 5 Dec 2011 by Drugs.com

MONDAY, Dec. 5 – Children exposed to the epilepsy drug valproate have a nearly three times higher risk of having an autism spectrum disorder, new research finds. Researchers in Denmark used national birth data that included nearly 656,000 children born in that country between 1996 and 2006 to 428,000 women. Using a national prescription drug registry, they identified women who had filled a prescription for valproate (Depakote) shortly before pregnancy through the day of the child's birth. Using the Danish Psychiatric Register, researchers then identified children who were diagnosed with an autism spectrum disorder, which can include both severe and milder forms of autism, and children with early-onset, more severe autism. After taking into account certain factors such as maternal age, the child's gender and other factors that influence autism risk, researchers found that children ... Read more

Related support groups: Depakote, Epilepsy, Depakote ER, Autism, Divalproex Sodium, Depakote Sprinkles

FDA Medwatch Alert: Valproate Products: Drug Safety Communication - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)

Posted 30 Jun 2011 by Drugs.com

Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics ISSUE: FDA notified healthcare professionals that children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy. This conclusion is based on the results of epidemiologic studies that show that children born to mothers who took valproate sodium or related products throughout their pregnancy tend to score lower on cognitive tests (IQ and other tests) than children born to mothers who took other anti-seizure medications during pregnancy. See the Drug Safety Communication for a data summary and additional information. ... Read more

Fetal Exposure to Common Epilepsy Drugs May Harm Kids' IQ: FDA

Posted 30 Jun 2011 by Drugs.com

THURSDAY, June 30 – The U.S. Food and Drug Administration on Thursday advised doctors to warn women of childbearing age that fetal exposure to certain drugs used to control seizures or migraines appears to diminish intellectual abilities in offspring. The drugs include so-called "valproate products" – medications such as valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, Depakote ER), valproic acid (Depakene, Stavzor), and their equivalent generic formulations, the FDA said in a statement. Children born to women who take these medications during their pregnancy "have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy," the FDA said. The agency said it based its conclusions on epidemiological studies that showed that fetal exposures to the drugs tended to correlate with lower scores on IQ and ... Read more

Women Taking Certain Epilepsy Drugs Can Safely Breast-Feed, Study Suggests

Posted 24 Nov 2010 by Drugs.com

WEDNESDAY, Nov. 24 – There's encouraging news for women with epilepsy who want to nurse their babies. Children whose mothers took certain anti-seizure medications while breast-feeding don't appear to suffer any negative cognitive effects by age 3, a new study finds. The multi-center study looked at nearly 200 children whose mothers took one of four common antiepileptic drugs, and found no difference in IQ levels at age 3 among those who were breast-fed versus formula-fed. "For women who have epilepsy, this is one less thing that they as new mothers have to worry about," said lead author Dr. Kimford Meador, a professor of neurology at Emory University in Atlanta. The study was published in the Nov. 24 online edition and in the Nov. 30 print issue of the journal Neurology. The findings are part of the Neurodevelopmental Effects of Antiepileptic Drugs study, an ongoing trial looking at ... Read more

Teens of Epileptic Mothers May Lag Academically: Study

Posted 4 Nov 2010 by Drugs.com

THURSDAY, Nov. 4 – Teens born to women who took two or more epilepsy drugs while pregnant fared worse in school than peers with no prenatal exposure to those medications, a large Swedish study has found. Also, teens born to epileptic mothers in general tended to score lower in several subjects, including math and English. The findings support earlier research that linked prenatal exposure to epilepsy drugs, particularly valproic acid (brand names include Depakene and Depakote), to negative effects on a child's ability to process information, solve problems and make decisions. "Our results suggest that exposure to several anti-epileptic drugs in utero may have a negative effect on a child's neurodevelopment," said study author Dr. Lisa Forsberg of Karolinska University Hospital. The study was published online Nov. 4 in Epilepsia. The study was retrospective, meaning that it looked ... Read more

Epilepsy Drugs Don't Raise Suicide Risk, Study Shows

Posted 5 Aug 2010 by Drugs.com

WEDNESDAY, Aug. 4 – In 2008, the U.S. Food and Drug Administration required epilepsy medications to bear a warning label about an increased risk of suicidal behaviors. The move came after an agency review of 199 studies that found patients taking the drugs showed about twice the risk of suicidal behavior. But now a study of more than 5 million patients contradicts the FDA's findings. It suggests that the increased risk of suicide has more to do with the conditions for which these drugs are prescribed than the medications themselves. For the study, researchers in Spain and the United States evaluated the health records of primary care patients in England. They found that people with epilepsy who currently use an antiepileptic drug are at no greater risk of suicide-related events than those who aren't taking the medications. "In our opinion, in the long term, it is not the drugs ... Read more

FDA Medwatch Alert: Antiepileptic Drugs

Posted 5 May 2009 by Drugs.com

[UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of ... Read more

FDA Adds Suicide Warning to Epilepsy Drugs

Posted 16 Dec 2008 by Drugs.com

TUESDAY, Dec. 16 – The U.S. Food and Drug Administration announced Tuesday that it was adding a label warning on heightened suicide risk for users of antiepileptic drugs. The move, which follows the advice last summer of an FDA advisory panel, stops short of slapping the strongest "black box" warning on this class of drugs, which includes widely used medications such as clonazepam (Klonopin), phenytoin (Dilantin) and topiramate (Topamax). "Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. But, he added, "patients who are currently taking an antiepileptic medicine should not make ... Read more

Related support groups: Klonopin, Lyrica, Lamictal, Topamax, Depakote, Keppra, Trileptal, Tranxene, Carbatrol, Zonegran, Zarontin, Di-Phen, Mysoline, Gabarone, Gabitril

First Generic Versions of Depakote Approved

Posted 29 Jul 2008 by Drugs.com

TUESDAY, July 29 – The first generic versions of Depakote (divalproex sodium) have been approved by the U.S. Food and Drug Administration to treat epileptic seizures, migraine headaches and bipolar disorder, the agency said Tuesday. Eight firms were granted license to produce generic versions of the brand-name drug made by Abbott Laboratories. The generics will have the same label warnings as the brand-name medication, including cautions about increased risk of severe liver damage, inflamed pancreas, and neural tube birth defects. "Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient with the same amount of high quality, safe and effective drug as the name brand product," Gary Buehler, director of the FDA's Office of Generic Drugs, said in an agency news release. More information To learn more about this drug, please see Depakote information ... Read more

Related support groups: Depakote

FDA Medwatch Alert: Depakote / Depakene / Depacon (divalproex sodium / valproic acid / valproate sodium)

Posted 17 Jun 2002 by Drugs.com

FDA and Abbott strengthened the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the label for Depakote Tablets, Depakote ER Tablets, Depakote Sprinkle Capsules, Depakene Capsules and Syrup and Depacon for Injection. Healthcare professionals were informed that hyperammonemic encephalopathy, sometimes fatal, has been reported following initiation of valproate therapy in patients with urea cycle disorders [UCD], a group of uncommon genetic abnormalities. Patient criteria to consider in evaluation for UCD prior to initiation of valproate therapy are offered.[June, 2002 Letter - Abbott][June, 2002 Full, Revised Label - Abbott] Read more

Related support groups: Depakote, Depakene

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Bipolar Disorder, Migraine Prevention, Migraine Prophylaxis, Mania, Epilepsy, Hyperekplexia