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FDA Approves Restless Legs Syndrome Drug
May 6, 2005 -- The FDA has approved Requip to treat moderate-to-severe Requip was first approved by the FDA in 1997 to treat Parkinson's disease.
RLS affects nearly 10% of the population, says the FDA. The condition is characterized by an urge to move the legs, usually accompanied by or caused by uncomfortable leg sensations like a creepy-crawly feeling, tingling, pulling, or pain.
For most people with RLS, symptoms begin or worsen during periods of rest or inactivity and are partially or totally relieved by movement. Symptoms typically worsen or occur only in the evening or at night, and can disturb sleep.
Woman are twice as likely to be affected by the condition compared with men, and the condition can worsen with age. At first, restless legs syndrome symptoms may be mild and sporadic, but over time they may get worse. After age 50, many people with restless legs syndrome have daily symptoms and significant sleep problems.
The In some people, it's a primary condition, which means it's not caused by another health factor. In others, it may be a secondary condition linked to pregnancy, iron deficiency, or renal (kidney) failure.
Requip was approved for moderate to severe primary RLS, says the FDA and the drug's maker, GlaxoSmithKline. GlaxoSmithKline is a WebMD sponsor.
FDA: Requip 'Effective' Against RLS
Requip was in three studies, says the FDA.
The studies only included adults with the primary form of RLS. People with RLS stemming from other conditions (such as pregnancy, kidney failure, and iron deficiency) were excluded from the trials.
The studies measured different aspects of restless legs syndrome including severity of muscle movement and discomfort, sleep disturbance, mood, overall effect on quality of life, and improvement following treatment.
"All three studies demonstrated a statistically significant difference between the treatment group receiving Requip and the group receiving placebo," says an FDA news release.
Requip Side Effects
Common side effects of Requip reported in the studies include nausea, headache, and vomiting, says the FDA.
The drug's label will also include a caution that Requip has been associated with sedating effects, including somnolence (sleepiness) and the possibility of falling asleep while engaged in activities of daily living, including driving.
Fainting (syncope) or low blood pressure (symptomatic hypotension) may occur, particularly during initial treatment or dosing, says the FDA.
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Restless Legs Syndrome
