Tamiflu May Be Linked to Risk for Self-Injury and Delirium

November 14, 2006 — The US Food and Drug Administration (FDA) and Roche Laboratories Inc have notified healthcare professionals regarding safety labeling revisions for oseltamivir phosphate (Tamiflu capsules and suspension) that warn of the potential risk for neuropsychiatric events associated with its use.

The warning was based on postmarketing reports (primarily from Japan) suggesting that patients with influenza receiving oseltamivir, particularly children, may be at increased risk for self-injury and delirium.

Although the role of the drug remains unclear, patients receiving oseltamivir should be closely monitored for signs of abnormal behavior, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

Oseltamivir is indicated for the prophylaxis of influenza and treatment of uncomplicated acute illness in those who have been symptomatic for no longer than 2 days. It is approved for use in patients aged 1 year and older.

Adverse events potentially related to use of oseltamivir should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.




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Saludos Cordiales
Dr. José Manuel Ferrer Guerra

Lyrica May Relieve Fibromyalgia Pain say Denise Mann

Nov. 14, 2006 (Washington, D.C.) -- The seizure drug Lyrica may offer extended pain relief for people with fibromyalgia.

That's according to New research presented at the 2006 annual meeting of the American College of Rheumatology.

Fibromyalgia is a chronic pain syndrome marked by widespread aches, pains, stiffness, fatigue, and trouble sleeping. About 2%-4% of the U.S. Population has the condition, according to the American College of Rheumatology.

There is no FDA-approved treatment for fibromyalgia. People with fibromyalgia are treated with a variety of medications approved for other conditions, including low doses of antidepressants, antianxiety medications, and analgesics.

The New study suggests that Lyrica may improve pain in people with the disorder and that these improvements may last at least six months.

Exactly how Lyrica works in fibromyalgia is not fully understood. Fibromyalgia may be caused by abnormalities in the central nervous system that affect how people process painful stimulation; Lyrica acts on the central nervous system.

Long-Term Pain Relief

The New study was conducted in two parts. The first part comprised 1,051 people with fibromyalgia who took 300, 450, or 600 milligrams of Lyrica daily for six weeks. Participants who showed a greater than 50% reduction in their pain and said that they felt "much" or "very much" better were moved into a six-month study in which they received a dummy pill (placebo) or an optimal dose of Lyrica.

Most of the participants were white women, with an average age of 50 and an average duration of fibromyalgia of 7.8 years.

One-fourth of people who received a placebo saw a worsening of their symptoms in seven days, compared with 34 days among people who took Lyrica.

Overall, 61% of people taking placebo pills lost the response they had seen in the first part of the study, compared with 32% percent of those who took Lyrica, the study showed.

Twice as many people who took Lyrica experienced long-term pain relief compared with their counterparts who took a placebo.

"[Lyrica] demonstrated durability of pain relief in patients who responded and it was generally well-tolerated," says researcher Leslie J. Croffiord, MD, professor of rheumatology and women's health at the University of Kentucky in Lexington. Side effects included dizziness, sinusitis, joint pain, anxiety, and sleepiness.

Calling the New findings "interesting," Eric Ruderman, MD, an associate professor of medicine at the Northwestern University Feinberg School of Medicine in Chicago, tells WebMD that "based on this preliminary trial, a lot of people will be looking at this drug in fibromyalgia and the advantage of this agent is that it has a certain durability to it."

He adds that "this is the second study to show benefit in terms of pain and, in general, it was well-tolerated and provided pretty durable pain relief."

Though six months is not a lifetime, the ideal scenario for chronic disease like fibromyalgia is to find something you can remain on without cumulative side effects.

Lyrica is also FDA-approved for diabetic nerve pain and nerve pain following shingles. It is manufactured by Pfizer. Pfizer is a WebMD sponsor.


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SOURCES: 70th annual meeting of the American College of Rheumatology, Washington, D.C., Nov. 10-15, 2006. Leslie J. Croffiord, MD, Gloria W. Singletary Professor of Rheumatology and Women's Health, University of Kentucky. Eric Ruderman, MD, associate professor of medicine, Northwestern University Feinberg School of Medicine, Chicago.

Reviewed by Louise Chang




Saludos Cordiales
Dr. José Manuel Ferrer Guerra