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UCB Announces FDA Approval for Keppra in Infants and Children from One Month of Age with Partial Onset Seizures
Posted 26 Jan 2012 by Drugs.com
ATLANTA--(BUSINESS WIRE)--Jan 25, 2012 - UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra (levetiracetam) tablets and oral solution as adjunctive therapy in the treatment of partial onset seizures in adults and children one month of age and older with epilepsy. Keppra was previously approved in the U.S. as adjunctive therapy for partial onset seizures in adults and children four years of age and older with epilepsy. “As a leader in epilepsy, UCB has a responsibility to develop effective medicines that address unmet medical needs,” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB. “Our continuing development program with Keppra in young children demonstrates our long-term commitment to epilepsy.” The approval was based on data from a Phase III, double-blind, randomized, multi-center, placebo-controlled s ... Read more
Related support groups: Seizures, Keppra, Levetiracetam
Newer Epilepsy Meds Less Likely to Cause Birth Defects: Study
Posted 17 May 2011 by Drugs.com
TUESDAY, May 17 – Newer epilepsy medications don't increase the risk of major birth defects in women taking these drugs during the first trimester of pregnancy, according to new research. But because the drugs are relatively new, further studies are needed to get a clearer picture of their safety profile, experts said. In a large study of children born in Denmark, including those exposed to newer anti-epileptic drugs, researchers found the rate of major birth defects was 3.2 percent for babies born to women taking the epilepsy medications and 2.4 percent for women not taking these drugs. "In a nationwide Danish study of more than 800,000 births, we found no support for an increased risk of birth defects following use of newer generation anti-epileptics in early pregnancy," said the study's lead author, Ditte Molgaard-Nielsen, an epidemiologist at Statens Serum Institute in Copenhagen. ... Read more
Related support groups: Gabapentin, Lamictal, Neurontin, Topamax, Keppra, Lamotrigine, Trileptal, Topiramate, Levetiracetam, Oxcarbazepine, Keppra XR, Horizant, Lamictal Blue, Lamictal XR, Gralise
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
Related support groups: Lyrica, Gabapentin, Lamictal, Neurontin, Topamax, Depakote, Tegretol, Keppra, Lamotrigine, Trileptal, Depakote ER, Topiramate, Carbamazepine, Pregabalin, Tegretol XR
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
Related support groups: Seizures, Lyrica, Lamictal, Topamax, Depakote, Epilepsy, Keppra, Trileptal, Seizure Prevention, Carbatrol, Zonegran, Di-Phen, Depakene, Gabitril, Gabarone
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, Di-Phen, Zarontin, Mysoline, Gabarone, Gabitril
Keppra XR Approved for Partial-Onset Seizures
Posted 15 Sep 2008 by Drugs.com
MONDAY, Sept. 15 – The U.S. Food and Drug Administration has approved an extended release form of Keppra (levetiracetam) as an add-on treatment for people with epileptic seizures aged 16 and older, Belgian drug maker UCB said Monday. "While many people with epilepsy are successfully treated with one or more of the currently available anti-epileptic drugs, a significant percentage still live with uncontrolled seizures or intolerable side effects," the company said in a news release. Once-daily Keppra XR is expected to be available at U.S. pharmacies by the end of the month, UCB said. The original form was approved in 1999. In clinical testing, the most common side effects included drowsiness and irritability, which also are common side effects of the drug's immediate-release form. More than 3 million people in the United States have epilepsy, and more than 40 percent of people who take ... Read more
FDA Medwatch Alert: Keppra (levetiracetam) Tablets and Oral Solution
Posted 8 Oct 2003 by Drugs.com
FDA and UCB Pharma advised healthcare professionals of the risk of dispensing errors between KEPPRA (levetiracetam), an antiepileptic, and KALETRA (lopinavir/ritonavir), an antiretroviral. Patients with epilepsy who do not receive their antiepileptic drug due to a dispensing error would be inadequately treated and could experience serious consequences, including status epilepticus. [September, 2003 Letter - UCB Pharma] PDF Format Read more
Related support groups: Keppra
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Seizures, Epilepsy, Bipolar Disorder, Neuralgia, New Daily Persistent Headache, Hyperekplexia