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Living with MS
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Treatments > Clinical Updates |
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| The latest updates on MS treatments and products. |
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- Tysabri Label Changed To Reflect Potential Liver Damage
February 2008 —A letter went out to prescribers of Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) from Biogen Idec and Elan Pharmaceuticals warning of an FDA-mandated label change that includes a new warning about the possibility of significant liver injury in people being treated with the drug. According to the new label, s igns of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose, and have also been reported after multiple doses.
- Guidelines for Administration of Human Papillomavirus (HPV) Vaccine (Gardasil®) to Multiple Sclerosis Patients
November 30, 2007 —Gardasil® (Merck) is available as a prophylactic vaccine, designed to prevent the following conditions in girls and women 9 to 26 years of age: HPV 6, 11, 16 and /or 18-related cervical cancer, cervical dysplasias, vulvar and vaginal dysplasias, condyloma acuminata
- Flu Vaccine and MS
October 2007—As in previous years, a flu shot is recommended as a safe and effective vaccination for people with MS. The flu shot can safely be taken by individuals who are on a disease-modifying medication.
- Low Dose Naltrexone Update
October 2006—We have received a number of inquiries about the use of low dose naltrexone (LDN) as a treatment for multiple sclerosis. There are currently no published data from controlled clinical trials to support the use of naltrexone in MS. Further study is needed to determine if this is a safe and effective treatment for people with MS.
- FDA Makes Changes to the Labeling of Cipro® (ciprofloxacin)
April 3, 2006—The FDA has approved safety labeling revisions for ciprofloxacin HCl (Cipro®) tablets and oral suspension (Cipro®), made by Bayer Pharmaceuticals Corporation, to warn that their use is contraindicated in patients receiving tizanidine HCl (Zanaflex®), made by Elan Pharmaceuticals, Inc.
- Medicare Suspends Cap On Rehabilitation Services For Beneficiaries With MS
March 2006—On January 1, 2006, Medicare beneficiaries became subject to a $1,740 cap on outpatient PT and speech language pathology services and a separate $1,740 per beneficiary limit on occupational therapy. However, the Centers for Medicare and Medicaid (CMS) recently issued three transmittals outlining a one-year exceptions process for medically necessary therapy services that can be obtained two ways: by an automatic exception or by manual exception.
- FDA Announced Withdrawal of Pemoline (Cylert) From the Market
November 8, 2005—Cylert, a central nervous system stimulant that was approved by the FDA for the treatment of attention deficit hyperactivity disorder (A DH D), has also been used to treat fatigue in MS. The FDA has now determined that the risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug. In May 2005, Abbott chose to stop sales and marketing of Cylert in the U.S. All generic companies have also agreed to stop sales and marketing of this product (pemoline tablets and chewable tablets).
- Zanaflex® Capsules (tizanidine hydrochloride)
September 2005—Acorda Therapeutics, the makers of Zanaflex Capsules, would like consumers to be aware that there is an important product difference between Zanaflex Capsules and Zanaflex tablets and generic tizanidine tablets.
- The Uses of Botulinum Toxin in MS
August 2005—Since the approval in mid-2002 of Botulinum Toxin Type A for the temporary improvement of facial wrinkling, botulinum toxins have received a great deal of publicity. In addition to their cosmetic uses, however, the toxins have a variety of medical applications, including some for people with MS.
- Neutralizing Antibodies
August 2005—Over the past decade, there has been debate among MS specialist physicians about the role of neutralizing antibodies (NAbs) in treatment decisions and treatment outcomes.
- New Capsule Formulation for Tizanidine
January 2005—The FDA recently approved a capsule formulation of the drug tizanidine (Zanaflex®), which is used to manage spasticity in MS and other disorders. |
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