法国赛诺菲的喜保宁安全性怎么样？

It is an irreversible GABA transaminase inhibitor that can increase the levels of GABA in the brain and cerebrospinal fluid. This drug has been used in Europe since the 1990s to treat infantile spasms, and its effect is better than ACTH. In 2009, the U.S. FDA approved Vigabatrin for use in infantile spasms in the United States. Currently, Vigabatrin has been listed as a first-line drug treatment for infantile spasms in Europe and North America, and may also have a certain effect on drug-refractory complex partial seizures in TSC patients.

France's Sanofi-Aventis is the largest pharmaceutical company in Europe and the fourth largest in the world (after Pfizer, Johnson & Johnson and GlaxoSmithKline, and higher than Merck and AstraZeneca). Sanofi Group holds leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine and vaccines. Sanofi's status in the field of vaccines is equivalent to GSK and its research and development of anti-cancer drugs is equivalent to Novartis. It is a well-deserved leading biopharmaceutical company in the world. So, how safe is Vigabatrin from Sanofi of France?

The side effects of Vigabatrin include drowsiness, reduced muscle tone, weight gain, insomnia, etc., but its biggest disadvantage is its impact on visual field. Patients may suffer from irreversible concentric visual field defects. The exact mechanism of this side effect is unknown, but it may be due to decreased function of cones and amacrine cells. This side effect is more common in adult patients than in pediatric patients, with an incidence rate of approximately 25%–50% in adult patients, approximately 15% in pediatric patients, and approximately 15%–31% in infants and young children. The time from the start of treatment to the remission of epilepsy is about 12-35 days. The probability of visual impairment during this period is relatively low. It is currently believed that if there is no obvious effect after more than 12 weeks of use, discontinuation of the drug can be considered.

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