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WSJ BLOG/Health: New Caution Urged Over Sole Oral MS Drug On the Market

(This story has been posted on The Wall Street Journal Online's Health Blog at http://blogs.wsj.com/health.) The FDA says the only oral multiple-sclerosis drug on the market -- Novartis's Gilenya -- shouldn't be used in patients with a recent history of stroke or some heart problems. As WSJ reports, a safety review of the treatment was prompted by a report in November of a 59-year-old patient dying in the U.S. less than a day after taking the first dose of the drug. Although the agency said an exact cause of the patient's death couldn't be identified, it continues to recommend that doctors closely monitor the hearts of patients after they have been given the first dose of the drug because the treatment can lower a person's heart rate temporarily. Patients who have had a stroke or heart trouble within the past six months shouldn't take the drug, the FDA says. It also shouldn't be used in patients taking some kinds of medicines to treat heart arrhythmias. The FDA warning comes after Europe's drug regulator last month requested stronger safety warnings. The U.S. agency is currently reviewing another oral MS drug from Biogen Idec designed to work through a different mechanism than Gilenya. -For continuously updated news from The Wall Street Journal, see WSJ.com at http://wsj.com.

Stock News for Novartis (NVS)
DateTimeHeadline
12/16/201403:22:10Novartis Gets U.S. Approval for Hormonal Disorder Drug
12/12/201418:22:53Novartis: Afinitor Fails to Make a Significant Treatment Difference
12/03/201423:43:31Array BioPharma to Regain Global Rights to Cancer Therapy
12/03/201423:42:41Array BioPharma to Regain Global Rights to Cancer Therapy From...
11/26/201418:31:46Novartis to Divest Nicotine Patch Habitrol to Comply with FTC
11/21/201402:39:34Novartis Psoriasis Treatment Recommended for Approval by CHMP
11/06/201407:57:33Biosimilars: The Good, the Bad and the Unknown -- Barron's
10/29/201411:53:10Norway's Oil Fund Posts Flat Returns in 3Q
10/29/201411:13:35Norway's Oil Fund Posts Flat Returns in 3Q--Update
10/28/201413:20:12EUROPE MARKETS: European Stocks Rebound; Stoxx 600 Up 1%
10/28/201406:05:25EUROPE MARKETS: European Stocks Rebound; Stoxx 600 Up 0.7%
10/26/201422:31:12CSL to Buy Novartis Influenza-Vaccine Unit
10/26/201418:49:15CSL to Buy Novartis Influenza-Vaccine Unit for $275 Million
10/23/201407:33:40Novartis 3Q 2014 -- Forecast
10/10/201404:08:25Oxford Biomedica Inks New Collaboration Pact with Novartis
10/03/201411:32:27EU Approves Acquisition of Novartis Animal Health Division by...
09/22/201412:43:39Germany's Merck to Buy Sigma-Aldrich for $17 Billion--2nd Update
09/01/201412:45:13EUROPE MARKETS: Novartis Climbs, Iliad Drops: European Movers
09/01/201412:01:47EUROPE MARKETS: Novartis Up, Iliad Drops: European Movers
09/01/201408:27:44Ruble Hits New Record Low Against Dollar

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