Sunday, July 29, 2012

Doctors Petition for Limits on Painkillers -

A group of doctors and public health officials urged the Food and Drug Administration on Wednesday to curtail the overuse and abuse of prescription painkillers by changing labeling directions on how and when physicians should prescribe them.

The request came in a so-called citizens petition sent Wednesday to the F.D.A. by some 35 physicians, including Dr. Thomas A. Farley, the commissioner of the Department of Health in New York City, and Dr. Nirav R. Shah, the commissioner of the New York State Department of Health.

The F.D.A. rarely acts on the basis of such petitions, and it can take months or years for the agency to respond. However, the move by the group appears to be part of a broader campaign by public health officials to highlight the dangers posed by narcotic painkillers, or opioids, particularly when they are used at high dosages or over long periods of time.

"Overprescribing of opioids is harming many chronic pain patients," Edward Covington, director of the Neurological Center for Pain at the Cleveland Clinic, said in a statement.

Currently, narcotic painkillers are approved by the F.D.A. for use in the treatment of "moderate to severe" pain.

The drugs fall into two categories. One, known as short-acting drugs, includes products like Percocet or Vicodin in which a narcotic is combined with an over-the-counter painkiller. The other category, known as long-acting painkillers, includes drugs like OxyContin, fentanyl and methadone that use a pure narcotic, sometimes in a time-release form.

In its petition, the group asked the agency to limit the drugs' approved use to "severe" pain in patients other than those with cancer.

The petition also urged the agency to put labels on the products that urge doctors to limit the dosages at which the drugs are prescribed to treat noncancer pain and the period of time over which they are used.

Narcotic painkillers are now the most widely prescribed class of drugs in this country; they are also involved in an estimated 15,000 overdose deaths annually, largely involving their abuse.

The use of long-acting painkillers began soaring about two decades ago with the appearance of OxyContin. For years, the drug's manufacturer, Purdue Pharma, and some pain experts contended that such medications could be used safely at extremely high dosages in patients over long periods of time.

However, neither Purdue Pharma nor any drug producer has ever run significant studies to assess the long-term benefits or risks of the medications. And in recent years, studies have linked narcotic painkillers to a variety of dangers, like sleep apnea, sharply reduced hormone production and, in the elderly, increased falls and hip fractures.

Even if the Food and Drug Administration were to adopt the proposed labeling changes, doctors would be free to prescribe drugs "off label" in any way they choose. However, drug companies would face limitations in how they market the products.