Last week, the United States Food and Drug Administration (FDA) made it official: Lyrica, the trade name of the Pfizer drug pregabalin, was approved as a treatment for fibromyalgia. This is the first drug to be specifically approved for the treatment of fibromyalgia, this based on the findings that it reduced pain and improved the ability to perform the activities of daily living in a significant number of patients suffering from this chronic pain syndrome.
However, an FDA official cautioned that not all patients experienced benefit from Lyrica.
Lyrica was already approved for the treatment of other chronic pain disorders, including pain associated with shingles and diabetic neuropathy. This additional approval was based upon two large studies which concluded that benefit could be had with daily dosages of Lyrica in the 300 mg to 450 mg range. The use of Lyrica resulted in an increased time to loss of therapeutic response compared to placebo over a six month period.
Any adverse effects appeared to be dose-related, and include dizziness, sleepiness, blurred vision, weight gain, dry mouth, and swelling of the hands and feet. In addition, Lyrica can adversely affect motor function and cause difficulty with concentration. Withdrawals from the studies occurred mostly due to dizziness and somnolence.
Assuming a patient's kidneys are healthy, dosing should begin at 75 mg twice daily; this can be gradually increased to 150 mg twice daily if necessary, and then 225 mg twice daily, if needed and tolerated. Patients with kidney disease will have to have the dosage decreased depending on the severity of the kidney disorder.
So, while it is a welcome thing that a drug is approved for fibromyalgia, it is certainly not a perfect drug, and a drug which does not work in all fibromyalgia patients. But fibromyalgia can be associated with such widespread and relentless pain, and it is my experience that Lyrica can help many of these patients. I also believe that fibromyalgia patients are grateful that there is a recognition that drugs need to be evaluated for the treatment of fibromyalgia. Hopefully, insurance companies will recognize the importance of this new FDA-approved indication for Lyrica, and give it a prominent place in their formularies.
In conclusion, Lyrica is only one more weapon in the fight against chronic pain. It should in no way replace the other modalities that can be helpful in fibromyalgia, which include good sleep hygiene, a graded exercise program, physical therapy, and a positive attitude. This Pfizer drug is certainly not a cure for everyone with fibromyalgia.
Talk it over with your doctor and your stock broker.
Published On: July 09, 2007