FDA Approves H.P. Acthar(R) Gel for the Treatment of Infantile Spasms

FDA Approves H.P. Acthar(R) Gel for the Treatment of Infantile Spasms

-Acute MS Relapse Treatment Now Approved for Rare Form of Childhood Epilepsy- -Modernized Acthar label retains indications for MS exacerbations, nephrotic syndrome, and 15 other medical conditions-

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Clinical Trials in Children with Intractable Epilepsy

Clinical Trials in Children with Intractable Epilepsy

Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

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US Drug Carbohydrate Content

US Drug Carbohydrate Content

Below is a list of AEDs (brand and generic) compiled by Yatin Patel, Doctor of Pharmacy Candidate of Wingate School of Pharmacy, August 2010 while at ICE for a Drug Information Rotation. Dr. Michelle Welborn has checked for accuracy of information.

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Stiripentol and Anesthesia

Most anesthetics are metabolized in the liver and will interact with stiripentol, and to what extent is unknown, making it impossible for a recommendation to decrease stiripentol dose or decrease anesthetic dose.

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Alternative Therapy

Alternative Therapy

Alternative therapies in treating epilepsy Yatin Patel Doctor of Pharmacy Candidate Wingate University School of Pharmacy Michelle Welborn, PharmD Preceptor Intractable Childhood Epilepsy Alliance www.ice-epilepsy.org Abstract Many people in the  United States experiment with  complementary and alternative medicines (CAM) on regular basis. The objective of this article is to provide a synopsis of available literature regarding use of alternative therapies in the treatment of epilepsy. Evidence based data on efficacy of CAM therapies in...

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Stiripentol Use in Children with Ds

Stiripentol Use in Children with Ds

Stiripentol Use in Children with Dravet Syndrome Data Source: Dravet Syndrome Patient Registry July 2008 Number of completed surveys: 22 Number of children using stiripentol: 8 Michelle Welborn, PharmD September 2008 This research was generated by the preliminary Dravet syndrome patient registry launched in 2008 and was submitted to be used for application of Orphan Drug Designation for stiripentol in the United States. Stiripentol was granted Orphan Drug Designation in November 2008. Current age of child: Race: How long has your child been...

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US Drug Approval Process

US Drug Approval Process

How much time and money does it take to bring a drug to market in the United States?  According to FDA estimates, it takes an average of 8 ½ to 17 years, from drug conception to marketing, before a drug is finally FDA approved for use in the general patient population.  An article published in Health Affairs (1996) estimated the cost of brining a new drug to market as being between $500 and $2,000 million.  But before a drug (chemical) may undergo human testing towards drug approval, pre-clinical research must be conducted.  In...

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Drug Selection with the Ketogenic Diet

Drug Selection with the Ketogenic Diet

Guidelines for Drug Selection in Patients on the Ketogenic Diet The following data has been compiled as guidance to be used when prescribing for children who are on the ketogenic diet.  Whilst best efforts have been made to ensure accuracy and completeness of the list, USERS MUST ENSURE THEY CHECK DETAILS WITH MANUFACTURERS, PHARMACISTS OR MEDICINES INFORMATION DEPARTMENTS AS APPROPRIATE. The information given relates to details declared by manufacturers.  The ingredients that are listed are those that have been deemed to be particularly...

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Orphan Drug Act of 1983

Orphan Drug Act of 1983

& Rare Diseases Approximately 5,000 rare diseases have been identified. 10-20 million Americans suffer from rare diseases, 50% of which are pediatric patients. A disease is considered rare or ‘orphan’ when the prevalence in the United States is less than 200,000. The diesease is termped ‘orphan’ because the pharmaceutical industry historically has not had an interest in developing treatments for these small patients populations. Drugs that have been FDA-aproved for use in these patients populations are termed orphan...

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Role of Inflammation in Epilepsy and Treatment With IVIg

Role of Inflammation in Epilepsy and Treatment With IVIg

The aim of this article is to review evidence discovered regarding the link between epilepsy and inflammation including the use of IVIg for treatment in epilepsy. Trauma and infection in the brain will initiate and recruit the immune system to the site of damage. Inflammation has been observed in both animal and humans.

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