Treatment Updates

Bayer HealthCare Pharmaceuticals Launching New Needle for Betaseron

Sep 24, 2008
Bayer HealthCare Pharmaceuticals Inc. will be launching a new 30-gauge needle (the same size used for insulin and pediatric injections) and new optional autoinjector (BETAJECT® LITE) at the end of October. The new autoinjector will replace all previous autoinjectors; use of any autoinjector other than this latest version may result in people not receiving their full dose of medication. People who are currently taking Betaseron can log onto www.betaseron.com/thinner or call BETAPLUS at 1-800-788-1467 for more information about the new needle and to request the new autoinjector.

New Recommendations from the FDA Concerning the Monitoring of Cardiac Function in People Taking Mitoxantrone

Aug 11, 2008
In July 2008, the FDA issued new recommendations for cardiac monitoring of people taking mitoxantrone (marketed as Novantrone® by EMD Serono and also available in generic form). In addition to the earlier recommendation that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to the administration of each dose, the FDA further recommends that all patients with MS who have completed treatment with mitoxantrone receive yearly quantitative LVEF evaluations to detect late-occurring cardiac toxicity.

Two New Cases of PML Develop in People with MS Taking Tysabri

Aug 01, 2008
Biogen Idec and Elan Pharmaceuticals informed drug regulatory authorities about two new confirmed cases of PML in individuals who were taking Tysabri® (natalizumab) as a monotherapy (not in combination with other therapies). PML (progressive multifocal leukoencephalopathy) is a viral infection of the brain that usually leads to death or severe disability. Although FDA prescribing information includes a black box warning about the risk of PML, the three previous cases of PML that occurred in the context of clinical trials were in patients who had taken Tysabri in association with other immune-modulating or immune-suppressing medications.

Previous Report of Two Cases of Melanoma (Skin Cancer) Reported in People Taking Tysabri for MS Updated with Company Rebuttal

Jul 02, 2008
Physicians in Boston have reported two cases of melanoma (skin cancer) that developed in women in their practice who were administered Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) to treat their multiple sclerosis. In a letter to the editor published in the July 3, 2008 issue of the New England Journal of Medicine (2008; 359[1]:99-100), Dr. Michael A. Panzara and other representatives of Biogen Idec, Inc., pointed out that individual case reports, such as were reported by Dr. Mullen and colleagues, do not provide an adequate basis for proving cause and effect.

Low Dose Naltrexone Update

Jun 02, 2008
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.

Change in Blood Donation Policy at American Red Cross

Apr 24, 2008
Until recently, people with MS were not permitted to donate blood at American Red Cross donation centers. The ban has now been lifted because no scientific evidence exists that MS is contagious or can be transmitted via blood. As of May, 2007, if other qualifications are met, blood from a person with MS may be donated to the American Red Cross.

Tysabri Label Changed To Reflect Potential Liver Damage

Feb 01, 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, signs 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

Nov 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

Oct 01, 2007
As in previous years, a flu shot is recommended as a safe and effective vaccination for people with MS. You can read about the Society's preventive care recommendations on the web site. The flu shot can safely be taken by individuals who are on a disease-modifying medication (Avonex®, Betaseron®, Copaxone®, Rebif®, or Tysabri®).

FDA Makes Changes to the Labeling of Cipro® (ciprofloxacin)

Apr 03, 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.

FDA Announced Withdrawl of Pemoline (Cylert) From the Market

Oct 01, 2005
Cylert, a nervous system stimulant that was approved by the FDA for the treatment of attention deficit hyperactivity disorder (ADHD), 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).

Neutralizing Antibodies

Aug 01, 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. This document summarizes the basic issues in the scientific literature.

The Uses of Botulinum Toxin in Multiple Sclerosis

Aug 01, 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.