Health trends

Parkinson's drug linked to heart failure

The United States Food and Drug Administration (FDA) notified health-care profesionals about a possible increased risk of heart failure with Mirapex (pramipexole). Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, FDA is not able to determine whether Mirapex increases the risk of heart failure. FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with Mirapex and will update the public when more information is available.

FDA evaluated a pooled analysis of randomised clinical trials and found that heart failure was more frequent with Mirapex than with placebo. However, these results were not statistically significant. FDA also evaluated two epidemiologic studies that suggested an increased risk of new onset of heart failure with Mirapex use. However, study limitations make it difficult to determine whether excess heart failure was related to Mirapex use or other influencing factors (see FDA Drug Safety Communication Data Summary for a detailed discussion of the studies).

Mirapex (pramipexole) is a prescription medicine used to treat the signs and symptoms of Parkinson's disease and moderate to severe symptoms of primary restless legs syndrome, in a class of medicines called dopamine agonists.

RECOMMENDATION: At this time, FDA has not concluded that Mirapex increases the risk of heart failure. Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Mirapex. Patients should continue to take their Mirapex as directed and should contact their health-care professional if they have any questions or concerns.

Source: The US Food and Drug Administration

New multiple sclerosis treatment approved

The US Food and Drug Administration recently approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).

"In a clinical trial, the relapse rate for patients using Aubagio was about 30 per cent lower than the rate for those taking a placebo," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients."

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions).

Over time, recovery periods may be incomplete, leading to progressive decline. The most common side effects of Aubagio experienced by patients in clinical trials include diarrhoea, abnormal liver tests, nausea, and hair loss.

Source: The U.S. Food and Drug Administration