Friday, 9 January 2015

EMA Backs Record Number of Drugs for Rare Diseases in 2014

The European Medicines Agency (EMA) gave positive opinions on a record number of orphan medicines for rare diseases in 2014.
Of a total of 82 medicines for human use recommended in 2014, 17 are intended for the treatment of a rare disease, "providing therapies for patients who often have only few or no treatment options," the EMA notes in a news release.
For comparison, the agency recommended 11 orphan medicines in 2013, eight in 2012, and four each in 2011 and 2010.
Antibiotic breakthrough may signal the end of drug-resistant superbugs

Scientists have come across a potential game-changer in the fight against drug-resistant superbugs - a new class of antibiotic that is resistant to resistance. Not only does the new compound - which comes from soil bacteria - kill deadly superbugs like MRSA, but also - because of the way it destroys their cell wall - the pathogens will find it very difficult to mutate into resistant strains.
FDA Issues Alert On Bed Wetting Drug

The US Food and Drug Administration (FDA) has asked the manufacturers to update drug labels and prescription information on desmopressin, available in tablet and nasal spray form and used to treat bed wetting, to include new information about severe hyponatremia, a condition caused by insufficient sodium in the blood which leads to seizures and sometimes death.

Desmopressin reduces water elimination via urine, thus preventing excessive thirst, urination and dehydration brought about by a range of conditions such as types of diabetes, physical injury, surgery and other medical conditions.

Children who were being treated with intranasal forms of desmopressin for bed wetting or primary nocturnal enuresis(PNE) were "particularly susceptible to severe hyponatremia and seizures" said the FDA.
Nasal spray formulations that contain desmopressin are no longer approved for the treatment of bed wetting (PNE), said the FDA, and they should not be used in patients with hyponatremia or who have a history of it.