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December 17, 2012
10:44 EDTJAZZFDA warns against use of Xyrem with alcohol, CNS depressant drugs
The FDA is reminding healthcare professionals and patients that the combined use of Xyrem (JAZZ) with alcohol or central nervous system depressant drugs can markedly impair consciousness and may lead to severe breathing problems. The use of alcohol with Xyrem is a new contraindication added to the Xyrem label, which already contraindicates its use with insomnia drugs. The use of Xyrem with other CNS depressant drugs such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants should generally be avoided. FDA recently evaluated reports of patients who died while taking Xyrem along with alcohol or other CNS depressants. The cause of these deaths is not clear because the reports contained incomplete information and did not adequately address confounding factor. Given some of the circumstances noted in the deaths, however, FDA determined that the recommendations in the Xyrem drug label should be strengthened to more strongly remind healthcare professionals and patients of the risks when using Xyrem with CNS depressant drugs or alcohol. Reference Link
News For JAZZ From The Last 14 Days
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November 24, 2015
14:42 EDTJAZZJazz Pharmaceuticals management to meet with Canaccord
Group dinner to be held in New York on November 30 hosted by Canaccord.
07:33 EDTJAZZMylan launches Clozapine Orally Disintegrating Tablets in the U.S.
Mylan (MYL) announced the U.S. launch of Clozapine Orally Disintegrating Tablets, 25 mg and 100 mg, the generic version of Jazz Pharmaceutical's FazaClo (JAZZ). Mylan received final approval from the FDA for its Abbreviated New Drug Application, or ANDA, for this product, which is used for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment.
November 18, 2015
08:28 EDTJAZZLeerink to hold a bus tour
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