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FDA Medwatch Alert: Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging

Posted 21 Jul 2014 by Drugs.com

ISSUE: American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016. This recall is the result of mislabeled inner unit dose blister packaging which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine. Failure to receive the proper dose of oxcarbazepine could increase the chances of having a seizure. Inadvertent consumption of ibuprofen may cause adverse reactions in a number of patients in which use of ibuprofen is contraindicated BACKGROUND: Oxcarbazepine is used for treating certain types of seizures in patients with epilepsy. Cartons of ... Read more

Related support groups: Ibuprofen, Advil, Trileptal, Motrin, Oxcarbazepine, Oxtellar XR, Nuprin, Advil Liqui-Gels, Motrin IB, Ibuprofen PMR, Midol IB, Motrin Childrens, Rufen, Children's Motrin, IBU, Genpril, Q-Profen, Ibu-6, Advil Migraine, Motrin Infant Drops

Epilepsy Drugs in Pregnancy May Affect Infants' Fine Motor Skills

Posted 25 Sep 2013 by Drugs.com

WEDNESDAY, Sept. 25 – Young children exposed to epilepsy drugs in the womb are at increased risk of having impaired fine motor skills, according to a new study. Exposure to the drugs in breast milk, however, does not appear to pose a threat. Researchers looked at data collected from Norwegian mothers about their children's language, behavior, and motor and social skills at the ages of 6 months, 18 months and 36 months. The women also provided information on breast-feeding during the first year for the study, which was published online Sept. 23 in the journal JAMA Neurology. Of the children in the study, 223 were exposed to one or more epilepsy drugs in the womb. At age 6 months, 11.5 percent of infants whose mothers took epilepsy drugs during pregnancy had impaired fine motor skills (which involve small muscle movements) compared with less than 5 percent of those who were not exposed ... Read more

Related support groups: Klonopin, Seizures, Clonazepam, Ativan, Valium, Lyrica, Lamictal, Topamax, Lorazepam, Depakote, Epilepsy, Diazepam, Keppra, Lamotrigine, Tegretol, Topiramate, Dilantin, Trileptal, Pregabalin, Carbamazepine

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, Topamax, Neurontin, Keppra, Lamotrigine, Topiramate, Trileptal, Levetiracetam, Oxcarbazepine, Gralise, Lamictal XR, Horizant, Keppra XR, Lamictal Blue, Lamictal Orange, Topamax Sprinkle, Gabarone, Lamictal ODT, Lamictal CD

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: Gabapentin, Lyrica, Lamictal, Topamax, Neurontin, Depakote, Keppra, Lamotrigine, Tegretol, Topiramate, Trileptal, Pregabalin, Carbamazepine, Depakote ER, Levetiracetam, Oxcarbazepine, Zonisamide, Divalproex Sodium, Tegretol XR, Zonegran

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, Zonegran, Carbatrol, Depakene, Felbatol, Gabitril, Di-Phen, Gabarone

FDA Medwatch Alert: Trileptal (oxcarbazepine) Tablets and Oral Solution

Posted 19 Apr 2005 by Drugs.com

Novartis Pharmaceuticals and FDA notified healthcare professionals about revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for TRILEPTAL (oxcarbazepine) tablets and oral suspension, indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children ages 4-16 years with epilepsy. The updated WARNINGS section describes serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) that have been reported in both children and adults in association with Trileptal use. The PRECAUTIONS section has been updated to include language regarding multi-organ hypersensitivity reactions that have been reported in association with Trileptal use. [April 18, 2005 - Dear Healthcare Professional Letter - Novartis][March 2005 - Revised Label, Highlighted - FDA] Read more

Related support groups: Trileptal

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, Zonegran, Tranxene, Carbatrol, Mysoline, Zarontin, Felbatol, Gabitril, Di-Phen, Gabarone, Tridione, Mesantoin, Peganone

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