FDA Approves New Pain Reliever
Lyrica Approved to Treat Pain Caused by Diabetes, Shingles
Jan. 3, 2005 -- The FDA has approved a new pain reliever designed to ease a potentially debilitating type of pain caused by diabetes or shingles.
Lyrica is approved for the treatment of pain associated with:
Diabetic peripheral neuropathy.
Nerve damage occurs when elevated blood sugar levels are too high for a long period of time. The areas of the body most commonly affected by peripheral neuropathy are the feet and legs. Nerve damage in the feet can result in a loss of foot sensation, increasing your risk of foot problems. In most cases, early symptoms, such as burning, tingling, or pins and needles, will become less severe when blood sugar is under control.
Postherpetic neuralgia. This type of nerve pain is a complication of shingles, a painful outbreak of rash or blisters caused by the same virus that causes chicken pox. Each year, an estimated 150,000 people develop postherpetic neuralgia, which causes constant stabbing, burning, or electric shock-like pain.
New Pain Reliever Approved
The FDA based its approval of Lyrica on six clinical trials, including three studies involving people with diabetes-related pain and three involving people with postherpetic neuralgia.
The studies showed that Lyrica relieved pain symptoms in a significant proportion of patients and pain relief began as early as the first week of treatment in some patients. Lyrica is made by Pfizer, Inc., a WebMD sponsor.
Side effects associated with Lyrica were considered mild to moderate. The most common side effects were dizziness, sleepiness, dry mouth, swelling, blurred vision, weight gain, and difficulty with concentration or attention. The number of people who discontinued use of the drug due to these side effects was low.
Officials say Lyrica is expected to be classified as a controlled substance.