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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.

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.

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.

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.

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).

Provides links to information on Drug and Device Information, Device Approvals and Safety information as well as links to other information government and private sector web sites

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.

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.

National Council on Patient Information and Education NCPIE - One of the original patient safety coalitions, MCPIE works to advance the safe, appropriate use of medicines through enhanced communication

The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.

Duke University Clinical trial and study to evaluate the safety, tolerability, and pharmacokinetics of the study drug Pregabalin in pediatric patients with partial onset seizures in addition to measuring how much pregabalin is in your child's blood and urine after he/she takes the study drug

Study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.

Hypothesis of study is that among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery.This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for preterm birth. The two risk factors to be studied are: Twin pregnancy - Triplet pregnancy

Safety and Efficacy of Vanquix™ Auto-Injector (Diazepam Injection) for the Management of Selected, Refractory Patients With Epilepsy Who Require Intermittent Medical Intervention to Control Episodes of Acute Repetitive Seizures

NICHD study is to determine how fast the drug oral baclofen is cleared from the body, the correct dose, and long-term safety and efficacy for children with spasticity.

Completed study on Motilin, a peptide, whose action is controlled by motilin receptors located in the gut. Action of Motilin at motilin receptors increases the gastric emptying rate (rate of emptying of food and fluid from the stomach). Compounds which stimulate motilin receptors therefore provide a potential approach to the treatment of a range of clinical conditions where delayed gastric emptying may contribute to symptoms, such as enteral feeding ntolerance (post-operative or intensive care patients), gastroparesis, diabetic gastroparesis, and functional dyspepsia. This study is the First Time In Human study for the motilin receptor agonist, GSK962040.

Study to Compare the Efficacy and Safety of Esomeprazole 20 mg Once Daily Oral Administration With Omeprazole 10 mg and Esomeprazole 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed Reflux Esophagitis

Effect of treatment on the movement disorder will be measured by a myoclonus scale and a dystonia scale as well as by assessment of overall functional status. Response at various dosages will be compared to baseline for all patients.Safety parameters including neurological examination, blood tests and EKG will be monitored throughout the treatment period and during withdrawal of the medication.

Eunice Kennedy Shriver National Institute of child Health and Human Development (NICHD) Study to evaluate the safety of high-dose Erythropoietin (Epo) in infants who did not get enough oxygen during birth. Erythropoietin is a hormone normally found in the body that may protect brain cells from damage due to lack of oxygen.