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FDA Food and Drug Administration - Index to Drug-Specific Information - This Index does not include all FDA approved drugs. It only includes drugs that have been the subject of a Healthcare Professional Information sheet, an Early Communication About an Ongoing Safety Review, or other important information. Please use Drugs@FDA to search for information on a drug not found in the Index.

Completed study comparing the blood drug levels of two prescribed medications, Immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.

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Preventing Seizure Progression - Carnegie Mellow University researchers have identified a new anticonvulsant compount that has the potential to stop the development of epilepsy. Findings are published in the journal Epilepsia.

Mayo clinic Epilepsy Treatments and drugs - Ketogenic Diet

FDA is an agency within the Department of Health and Human Services1 and consists of centers and offices responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

Completed study that evaluated the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy: II. Assess how infantile spasms interfere with development and whether this is partially reversible. III. Determine the predictors of good surgical outcome and whether surgery permanently controls seizures and improves development.

The first comprehensive comparative effectiveness clinical trial of three widely used anti-seizure drugs for childhood absence epilepsy - the most common form of epilepsy in kids - has established an evidence-based approach for initial drug therapy. Published March 4 in the New England Journal of Medicine*, data from the double-blind, randomized, comparative clinical trial fill a large information gap in the treatment of childhood absence epilepsy, also known as "petit mal" epilepsy. The research, which identifies important differences between drugs in seizure control and side effects, is expected to impact how physicians select and monitor initial therapy for children with the disorder and ultimately lead to improved outcomes.

Duke University and Multicenter, Open-label Study to Investigate the Safety, Tolerability and Pharmacokinetics of Lacosamine (LCM) Oral Solution (syrup) as Adjunctive Therapy in Children with Partial Onset Seizures. This study is being done to test the safety of the study drug Lacosamide (LCM) syrup and how the body processes it.

Study comparing diazepam, a drug that is labeled by the FDA for this indication, with lorazepam. The study will show whether one drug is more effective and safer than the other.

Korean study comparing the effect of anti-epileptic drugs' (AEDs) long-term treatment on cognitive function. This study is an open-label, randomized, multicenter comparative trial of lamotrigine versus carbamazepine"

"The purpose of this study is to record signatures from the fluid surrounding the spinal cord from people who have an implanted drug infusion system"

Study is to evaluate the pharmacokinetics (blood levels), pharmacodynamics (how the drug acts on the body), and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in new borns and pre-term infants (less than 44 weeks of age).

Study to obtain pharmacokinetic and safety data of bumetanide in newborns with refractory seizures. The overall hypothesis is that bumetanide, added to conventional antiepileptic (antiseizure) medications, will be a safe and well tolerated medication, compared with conventional antiepileptic drugs alone.

CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

MedWatch - FDA Safety Information and Adverse Event Report Program - MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.

As many more premature infants survive, the numbers of these infants with health problems increases. The rate of cerebral palsy (CP) in extremely premature infants is approximately 20%. Magnesium sulfate, the most commonly used drug in the US to stop premature labor, may prevent CP. This trial tests whether magnesium sulfate given to a woman in labor with a premature fetus (24 to 31 weeks out of 40) will reduce the rate of death or moderate to severe CP in the children at 2 years. The children receive ultrasounds of their brains as infants and attend three follow-up visits over two years to assess their health and development.

Charliet Foundation - Offering Hope through the Ketogenic Diet. Founded in 1994 after twenty month old Charlie Abrahams, having endured multiple daily seizures, and failed every available anti-convulsant drug and one brain surgery, was cured of his epilepsy by the ketogenic diet at Johns Hopkins Hospital. The diet was undertaken despite resistance from the five pediatric neurologists he had seen.