Quoted from http://www.bloomberg.com/news/2013-07-30/novartis-gilenya-patient-diagnosed-with-rare-infection.html
Novartis Gilenya Patient Diagnosed With Rare Infection
By Phil Serafino - Jul 30, 2013 11:50 AM ET
A patient taking Novartis AG (NOVN)’s Gilenya multiple sclerosis pill contracted a potentially deadly brain infection, adding to concern that the medicine may lose ground to a competing product.
Unlike a previous case, the patient hadn’t taken Biogen Idec Inc. (BIIB)’s Tysabri injection, an MS drug that increases the risk of the viral infection, known as progressive multifocal leukoencephalopathy, Novartis said in an e-mail today.
Quoted from http://www.japantimes.co.jp/news/2013/07/29/national/health-ministry-probes-diovan-skin-disruption-reports/#.UffW52SUx_w
Health ministry probes Diovan skin disruption reports
Kyodo
Jul 29, 2013
The health ministry is investigating reports of skin problems linked to the use of Diovan, Novartis Pharma K.K.’s popular drug for reducing high blood pressure, sources familiar with the matter said Monday.
After probing reports that skin sores occur after taking the drug, the Health, Labor and Welfare Ministry will make a decision, possibly next month, on whether to order the drug maker to add skin problems to the list of potential side effects included in the instructions for Diovan, the sources said.
The symptom being probed by the ministry and the Pharmaceuticals and Medical Devices Agency is a kind of eruption in which skin all over the body turns red and develops sores and blisters.
Quoted from http://www.reuters.com/article/2013/07/22/us-biogen-tecfidera-idUSBRE96L0UA20130722
Biogen says patient death unlikely linked to new MS drug
Mon Jul 22, 2013 5:48pm EDT
(Reuters) - The death of a patient who had taken Biogen Idec Inc's new multiple sclerosis drug, Tecfidera, was unlikely to be linked to the medicine, the company said on Monday.
Biogen said it was made aware last week of the death of a 59-year-old woman who had been treated with Tecfidera, and that it was actively gathering facts about the case.
Based on the circumstances of the case and the cause of death, "a link to Tecfidera is unlikely," said Biogen spokeswoman Kate Niazi-Sai.
"The patient was not on Tecfidera at the time of death," she added.
Pfizer and a South Carolina attorney have agreed on final settlement for about 660 Chantix lawsuits, according to a court document filed in federal court in Birmingham this morning.
Under an "omnibus stipulation of dismissal with prejudice" filed this morning in federal court in Birmingham, the plaintiffs' claims in the approximately 660 lawsuits are to be dismissed without costs or attorneys' fees to any party.
Quoted from http://consumer.healthday.com/disabilities-information-11/misc-birth-defect-news-63/antiepileptic-drug-pregnancy-epilepsia-release-batch-473-678329.html
Epilepsy Drugs in Pregnancy Tied to Developmental Delays in Children
Large Norwegian study followed offspring for up to 3 years
THURSDAY, July 18 (HealthDay News) -- The children of women who take drugs to treat epilepsy during pregnancy may be at increased risk for physical and mental developmental delays early in life, a large, new study finds.
Epilepsy is fairly common among women of childbearing age, and the use of antiepileptic drugs by pregnant women ranges from 0.2 to 0.5 percent.
In this study, researchers recruited Norwegian mothers at 13 to 17 weeks of pregnancy. For more than 61,000 children, mothers provided details about motor development, language skills, social skills and autistic symptoms at age 18 months. At 36 months, mothers provided that information for more than 44,000 children.
The researchers found that 333 of the children were exposed to antiepileptic drugs in the womb. At 18 months of age, these children were more likely to have motor skills problems and traits of autism. At 36 months of age, these children were more likely to have problems with motor skills and sentence skills, and traits of autism.
The children exposed to antiepileptic drugs also had an increased risk of birth defects, according to the study appearing July 18 in the journal Epilepsia.
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