Multiple Sclerosis Treatment

by Food and Drug Administration (FDA)

(Page 3 of 4)

The FDA has approved six drugs to treat MS, all injections. They cannot reverse the damage already caused by the disease, but they can help prevent relapses and further damage. In addition, a number of oral drugs can help alleviate some of the symptoms, such as fatigue, bladder infections, constipation, pain, depression, and involuntary jerking movements (spasticity).

The most recently approved MS drug, Tysabri (natalizumab), was licensed by the FDA in November 2004 to reduce the frequency of multiple sclerosis (MS) attacks in people with relapsing forms of MS. In February 2005, the drug manufacturer, Biogen Idec Inc., voluntarily suspended marketing of Tysabri because of two serious adverse events, including one death, reported with its use. A rare brain disease, progressive multifocal leukoencephalopathy (PML), was confirmed in two people with MS who had been taking Tysabri for more than two years.

PML can occur in people whose immune systems are suppressed. It often results in irreversible neurologic deterioration and death. Although the relationship, if any, between Tysabri and PML is not clear, the FDA concurred with the manufacturer that it voluntarily withdraw the drug from the market because of the serious nature of PML. The FDA has also prohibited new clinical trials with Tysabri until more information is available.

No previous cases of PML had been reported in the roughly 3,000 people who took Tysabri in clinical trials. The two people who developed PML were taking the drug in post-marketing studies required by the FDA.

People who were being treated with Tysabri should contact their physicians to discuss other treatments that may be appropriate. The FDA is working with the manufacturer to determine the best methods for assessing those who have received Tysabri in order to assure their safety and understand the connection, if any, between Tysabri and PML.

Four other treatments for people with relapsing MS are approved for lifelong use by the FDA: Avonex, Betaseron, and Rebif (beta interferons), and Copaxone (glatiramer acetate), a synthetic drug. All of these drugs reduce the frequency of MS attacks by influencing the activity of the immune system. In addition, Avonex and Rebif may slow down the rate of physical disability.

Each of the four drugs can be injected by the patient at home and each is used at regular intervals, ranging from once a day to once a week. Common side effects of the three interferon drugs are flu-like symptoms and reactions at the area of injection. Copaxone may trigger a short-term reaction that includes flushing, chest pain, heart palpitations, anxiety, and shortness of breath.

Another drug, Novantrone (mitoxantrone), is approved for people with secondary-progressive MS or those with rapidly worsening relapsing-remitting MS. This IV cancer chemotherapy drug is given in a medical facility. By suppressing the immune system, the drug may reduce new lesions, decrease relapses, and slow down the rate of disability. Because of the serious side effect of heart damage, Novantrone is restricted to use in an individual no more than four times a year for up to three years.

When it comes to choosing a treatment, Reingold says that's a decision for the patient to make with a physician, taking into account the patient's goal, quality of life, lifestyle, and insurance coverage, combined with the physician's perspective on what the best options might be.

"Each of these drugs is different," says Reingold. "They may be different biological molecules. They are given in different doses, they are given at different frequencies, they have different side effect profiles, and they cost different amounts.

"You may or may not be responsive to one drug," he adds, "and you may have allergic reactions or side effects to one drug or not to another drug. There's a certain amount of trial and error. We cannot currently tell at the onset of treatment which drug is going to be best for which people."

As yet, there are no approved treatments for primary-progressive MS. "The currently available drugs focus their actions on inflammation while the damage at this stage is caused from degeneration and not inflammation," says Jack Burks, M.D., a clinical professor at the University of Nevada School of Medicine in Reno, and vice president and chief medical officer at the Multiple Sclerosis Association of America (MSAA). "Patients with progressive MS can often benefit from rehabilitation therapies such as exercise, nutritional guidance, and psychological support to increase coping and adapting skills plus deal better with depression. Most people learn to recognize that quality of life is more related to having good relationships and feeling productive than running a 100-yard dash."

Doctors advise people with all forms of MS to get enough rest, eat healthily, not smoke, and to exercise regularly. "Every person with MS should be on a regular exercise program customized to their level of disability," says Bourdette. "Several studies of people with MS have demonstrated that exercise will improve fatigue, cardiovascular health, quality of life, and doesn't make their MS worse."

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.