U.S. And European Regulators reviewing Novartis AG Gilenya pill for multiple sclerosis
Concerns are being raised over Gilenya, the first oral drug for relapsing forms of multiple sclerosis in adults.
Today the European Medicines Agency in a statement that the drug Gilenya may harm the heart. The FDA is also reviewing the medication.
According to the drug manufacturer Novartis had stated that on November 23, a patient had died after starting the drug treatment. Among the total of eleven deaths excluding this one, there has been six unexplained deaths, three heart attacks and one disruption in heart rhythm, all of who had just started taking the drug according to London based EMA. They also have noted it is unclear what role if any had the drug Gilenya played.
The drug can temporarily slow down the heart rate however, the heart rate usually returns to normal after a couple of hours. In Europe the agency is recommending intense cardiovascular monitoring after the first dose is given. That monitoring should include an EEG before treatment and then continuously for the first six hours after treatment along with blood pressure and heart rate every hour.
Erica Jefferson spokesperson for the United States regulator had stated in an email that they have been in touch with the EMA and similar to what they are doing. She noted that the public will be notified once their review is complete to convey any recommendations or possible label changes.
Novartis states they are working with the EMA and are notifying doctors of the agency’s recommendation to increase the monitoring of patients hearts once they receive the first dose.
The EMA stated that the risk of low heart rate after first dose was known at the time the drug had been released.
The drug is widely available throughout the world.
Currently other drug manufactures such as Biogen and Sanofi are pushing ahead with their latest drugs for MS.
Some experts seem to believe that Biogen’s BG-12 will be top ranking in the world’s leading treatments for MS.
Analysts have noted that BG-12 just may have a competitive advantage due to its safety profile which appears to be basically clean based upon a two year information.
Multiple Sclerosis a debilitating neurological disease which affects around 2.5 million people world-wide. It attacks the nervous system and can result in numbness, loss of vision and paralysis. It affects twice as many women than men.
Many MS patients will try alternative therapies to get relief from symptoms instead of having to depend solely on medications.
Research reported in the Journal of Pediatric, Maternal & Family Health had reported that chiropractic had revealed improvements in symptoms of MS in women who had underwent chiropractic care.
In a case reported in that research the initial application of chiropractic along with nutritional advice which had included the eliminations of sugar and grains in the patients diet. The first priority was correcting the spinal and related neurological interferences. Interferences known as vertebral subluxations in which chiropractors do correct.
The patient had improvements in pain levels throughout her body just after twelve visits. Lung function and posture had improved. Gradually she was able to discontinue all of her medications.
Montel Williams is just one of the known names that advocate for chiropractic care. Williams uses chiropractic care to help manage his MS symptoms.
The goal of chiropractic care is to decrease pressure on the nerves so the body can function normally.
Chiropractors in or around Detroit:
18700 Woodward Avenue
A & L Chiropractic Clinic
24281 Middlebelt Road