<body bgcolor="#ffffff" text="#000000"> <a href="http://hyulo.free-best-hosting.com/?fp=ED4swLkU7H9owOJG1WdYzvn7J%2FHtxXvmZDhR4qlpU%2Bm3gnVF0XMbsWEXq8G1t9X%2B2ARePdIfqGhOyvztzsZkww%3D%3D&prvtof=WkZboISWitd3vrJg8VU8nmxLVzlOqG7ubtt9%2BUFL8RE%3D&poru=8g6s5RK5zlgn9LwDKvNtuB0%2BUSJsaowssOnYbjh7esqh4Yn%2FlR3KIW8FxnVjEwKdkDBjvneqwY2b9Iu2VFkpeUIRStYDS76MmiLe3oailOxio6YqZBHe01j%2BJSCpv87bpxtLBm5jRD9SGzl3jInmg3dfmtL9G9feuqg6B%2B%2B%2BP4lU%2B34fBh31ktFe8gyIOu8BwfEqzDA45M7Zp2kP6WLN9k0J0nLlb4zOUY%2Bf%2FFou9EAPl9vc%2BTqXiUWc6D3D4ieTbaeRYoeMxy%2FYwxaUOc%2F3aA%3D%3D&result=aT01NC44MS4yNDQuMjQ4JnU9Q0NCb3QlMkYyLjArJTI4aHR0cCUzQSUyRiUyRmNvbW1vbmNyYXdsLm9yZyUyRmZhcSUyRiUyOSZoPXd3dy4yNC03LW5ld3MuY29tJmhyPXd3dy4yNC03LW5ld3MuY29tJTJGYXJjaGl2ZXMlMkY2NTA1JnJmPQ%3D%3D">Click here to proceed</a>. </body> New Safety Info Added To Gilenya | 24-7-news.com cialis online

New Safety Info Added To Gilenya

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New safety information has been added to Gilenya, manufactured by Novartis AG. Gilenya (gingolimod) is approved for the treatment of relapsing-remitting multiple sclerosis (MS) and is meant to reduce the frequency of flare-ups and delay physical disability.

Now, regulators in the United States and in Europe are placing new safety precautions on the drug, said Bloomberg Businessweek. The label change followed 15 deaths, which prompted a three-month review of Gilenya.

In its statement, the European Medicines Agency (EMA) said that physicians should not be prescribing Gilenya to those patients who have a history of cardiovascular and cerebrovascular disease or to those who take medications that lower the heart rate, wrote Businessweek. The U.S. Food & Drug Administration (FDA) set a similar rule, and also mandates an electrocardiogram prior to the first dose and, again, after the first six-hour observation period.

According to the EMA, Novartis stated that in those patients for whom Gilenya treatment is needed, heart activity should be monitored for at least overnight following the first dose and continually for at least the first six hours, according to Businessweek.

The FDA also said that monitoring should continue for at least an additional two hours in those patients whose heart rate was the lowest in the six hours following the first Gilenya dose. Also, wrote Businessweek, patients who develop significant heart problems—slow heart rate or electrical cardiac conduction issues—should be monitored at least overnight and until the issue is resolved.

In December, Novartis said one U.S. patient died within 24 hours of beginning Gilenya treatment, which prompted reviews by both the U.S. and European regulators. Reports of 10 additional deaths among Gilenya patients followed. Novartis stated that six of the deaths were unexplained, three were due to heart attacks, and one was linked to a disruption of heart rhythm.

Now, said the EMA, it has looked at a total of 15 cases involving either sudden or unexplained deaths in Gilenya patients. “Most of the deaths and cardiovascular problems had occurred in patients with a history of cardiovascular problems or taking other medicines,” the regulator said. “However, the data reviewed were not conclusive as to whether Gilenya was the cause of the deaths,” it added, wrote Businessweek.

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