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FDA approves first 3-D printed drug

WASHINGTON — The Food and Drug Administration has approved the first prescription drug made through 3-D printing: a dissolvable tablet that treats seizures. Aprecia Pharmaceuticals said Monday the FDA approved its drug Spritam for adults and children who suffer from certain types of seizures caused by epilepsy. The tablet is manufactured through a layered process via 3-D printing and dissolves when taken with liquid. The Ohio-based company says its printing system can package potent drug doses of up to 1,000 milligrams into individual tablets. It expects to launch Spritam in the first quarter of 2016. The FDA has previously approved medical devices — including prosthetics — made with 3-D printing. An agency spokeswoman confirmed the new drug is the first prescription tablet approved that uses the process. Aprecia said in a statement it plans to develop other medications using its 3-D platform in coming years, including more neurological drugs. The company is privately owned. Doctors are increasingly turning to 3-D printing to create customized implants for patients with rare conditions and injuries, including children who cannot be treated with adult-size devices. The FDA held a workshop last year for medical manufacturers interested in the technology.  
nypost.com
over 5 years ago
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Medicines for preventing epilepsy following traumatic head injury | Cochrane

Traumatic head injury is a frequent event and can injure the brain. This severe injury is often followed by seizures (fits), which may worsen the damage and can lead to chronic epilepsy, a neurologic disorder characterized by frequent recurrent seizures. Antiepileptic drugs are usually given to suppress already diagnosed seizures. Their role in curing the disease and preventing the development of epilepsy in people who are considered at risk for seizures after any brain injury, including head trauma, is not well understood.  
cochrane.org
over 5 years ago
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Carbamazepine versus phenytoin monotherapy (single drug treatment) for epilepsy | Cochrane

Epilepsy is a common neurological disorder in which recurrent seizures are caused by abnormal electrical discharges from the brain. We studied two types of epileptic seizures in this review; generalised onset seizures in which electrical discharges begin in one part of the brain and move throughout the brain, and partial onset seizures in which the seizure is generated in, and affects one part of the brain (the whole hemisphere of the brain or part of a lobe of the brain). For around 70% of people with epilepsy, generalised onset or partial onset seizures can be controlled by a single antiepileptic drug. Worldwide, phenytoin and carbamazepine are commonly used antiepileptic drugs, however carbamazepine is used more commonly in the USA and Europe due to concerns over side effects associated with phenytoin. Phenytoin is still commonly used in developing countries in Africa, Asia and South America due to the low cost of the drug.  
cochrane.org
over 5 years ago
Sinaiem dark
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status-epilepticus-2

Your patient arrives by ambulance having a seizure.  EMS administered ativan 10 minutes ago.  You give a second dose but the seizure continues.  What should you do?  
sinaiem.org
over 5 years ago
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FDA Revokes Approval for Sun Pharma's Seizure Drug Over Compliance Issues

The U.S. Food and Drug Administration has revoked an approval issued in March to India's Sun Pharma Advanced Research Company Ltd (SPARC) to launch a drug for seizures, citing manufacturing quality problems at its production site.  
medscape.com
over 5 years ago