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FDA Approves Lyrica for Diabetic Neuropathy
The US Food and Drug Administration recently approved the drug Lyrica to treat nerve pain
caused by diabetes or shingles. Lyrica was developed by Pfizer and will available to patients
and physicians within the next three months. The drug reduces the dull throbbing pain diabetics
sometimes feel in their hands and feet.
The safety of Lyrica was established in over 9,000 patients. In all clinical trials, adverse
events were mild to moderate. The most common side effects associated with Lyrica compared
with placebo included dizziness, somnolence, dry mouth, peripheral edema, blurred vision,
weight gain and difficulty with concentration/attention. The discontinuation rate due to
side effects was low.
Nearly half of the 18 million Americans with diabetes will develop some form of diabetic
neuropathy and about 3 million diabetics will experience painful neuropathy, often described
as burning, tingling, stabbing, and a pins-and-needles feeling in the feet, legs, hands or
arms. An estimated 50,000 Americans develop nerve pain from shingles, which is a skin disease
caused by reaction to the same virus that causes chicken pox.
Lyrica is expected to be classified as a controlled substance in a category with lower
potential for misuse or abuse relative to controlled substances in other categories.
Approval to use Lyrica to treat epilepsy is pending with the FDA and could come soon.
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