The approval specified that flibanserin should not be used to treat low sexual desire caused by co-existing psychiatric or medical problems; low sexual desire caused by problems in the relationship; or low sexual desire due to medication side effects.As of 21 August 2015, The Pharmaceutical Journal reported that Sprout Pharmaceuticals had not yet made an application to the European Medicines Agency for a marketing authorisation. Advocacy groups
Even the Score, a coalition of womens groups brought together by a Sprout consultant, actively campaigned for the approval of flibanserin. The campaign emphasized that several approved treatments for male sexual dysfunction exist, while no such treatment for women was available. The group successfully obtained letters of support from the President of the National Organization for Women, the editor of the Journal of Sexual Medicine, and several members of Congress.Other organizations supporting the approval of flibanserin included the National Council of Womens Organizations, the Black Womens Health Imperative, the Association of Reproductive Health Professionals, National Consumers League, and the American Sexual Health Association.The approval was opposed by the National Womens Health Network, the National Center for Health Research and Our Bodies Ourselves. A representative of PharmedOut said "To approve this drug will set the worst kind of precedent — that companies that spend enough money can force the FDA to approve useless or dangerous drugs."
A gelastic seizure, also known as "gelastic epilepsy", is a rare type of seizure that involves a sudden burst of energy, usually in the form of laughing. This syndrome usually occurs for no obvious reason and is uncontrollable. It is slightly more common in males than females. This syndrome can go for very long periods of time without a diagnosis, as it may resemble normal laughing or crying if it occurs infrequently. It has been associated with several conditions, such as temporal and frontal lobe lesions, tumors, atrophy, tuberous sclerosis, hemangiomas, and post-infectious foci, but mainly hypothalamic hamartomas. The term "gelastic" originates from the Greek word "gelos", which means laughter. Signs and symptoms
The main sign of a gelastic seizure is a sudden outburst of laughter with no apparent cause. The laughter may sound unpleasant and sardonic rather than joyful. The outburst usually lasts for less than a minute. During or shortly after a seizure, an individual might display some twitching, strange eye movements, lip smacking, fidgeting or mumbling. If a person who has the seizures is hooked up to an electroencephalogram, it will reveal interictal epileptic discharges. This syndrome usually manifests itself before the individual reaches the age of three or four. The temporal lobes, and the hypothalamus are the areas of the brain with the most involvement with these seizures. This may cause learning disabilities, and faulted cognitive function as well. It is not uncommon for children to have tonic-clonic seizures, and atonic seizures directly following the seizure.