Study: Off-label drugs should be researched for safety

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http://www.usatoday.com/news/health/2008-11-24-off-label-drugs_N.htm

Study: Off-label drugs should be researched for safety

By Rita Rubin, USA TODAYAmong all the drugs prescribed to treat conditions for which they're not approved, doctors and patients should be most concerned about antipsychotics and antidepressants, a study suggests today.This "off-label" prescribing is a legal, common practice that is being questioned in some cases because of inadequate scientific evidence to support its safety and effectiveness.

BETTER LIFE: FDA warns about discount drug fraud; more news on medicines"Although previous research has highlighted the substantial frequency of off-label drug use without good evidence, we have identified and prioritized specific drugs warranting attention," the authors of the new study write in the journal Pharmacotherapy.

They list 14 drugs for which needed research into off-label use is most pressing. Three are antipsychotics, six are antidepressants. The researchers considered three factors in devising their list: the volume of off-label use with inadequate evidence, drug safety, and cost and market considerations.

Seroquel, an antipsychotic approved for treating schizophrenia and short-term manic or depressive episodes in bipolar disorder, topped the list. Three out of four times, doctors use the drug off-label, mainly for maintenance therapy for bipolar disease, says senior author Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center.

"It's not that these off-label uses are necessarily harmful or that these drugs don't work," Stafford says. The problem, he says, is that no one can be certain, because needed studies haven't been done.

The FDA requires drug companies to test their drugs only against conditions for which they're seeking approval. "Clearly, for many of these off-label uses, the manufacturers are benefiting enormously, and in some cases I think one could argue that off-label use has allowed them to circumvent the regulatory process," Stafford says. Although the regulatory process is not infallible, he says, "it does provide a level of scrutiny" beyond what the off-label uses have received.

Diedtra , a spokeswoman for the Pharmaceutical Research and Manufacturers Association, a trade group, said her organization could not comment on off-label prescribing. "That's nothing being driven by our companies," she said. "This is an activity that our companies aren't allowed to do under FDA regulations."

But according to a paper posted last month by the online journal PLoS Medicine, industry-paid "nationally known, influential academic physicians" help create "buzz" about off-label uses by writing about them for publication or presentation at scientific meetings. The article was written by physician e Fugh-Berman of town University Medical Center in Washington, D.C., and Melnick, a preventive medicine doctor in North Hollywood, Calif.

Earlier this month in PLoS Medicine, medical school professor Wilkes and law professor Margaret s, both of the University of California, , called for doctors always to inform patients that they want to use a drug off-label, giving them the chance to decide whether they want to take it.

READERS: Have you ever been prescribed a drug for off-label use? What did your doctor tell you? Is personal research necessary?

THESE MAY NEED CLOSER LOOK

A new study suggests that research into "off-label" prescribing prescribing drugs for conditions for which they're not approved is most pressing for the medications on this list.

Drug (Brand name)

Most-common on-label use

Most frequent off-label use

1. Quetiapine (Seroquel)

Schizophrenia

Maintenance therapy of bipolar disorder

2. Warfarin (Coumadin)

Atrial fibrillation

Hypertensive heart disease

3. Escitalopram (Lexapro)

Depression

Bipolar disorder

4. Risperidone (Risperdal)

Schizophrenia

Maintenance therapy of bipolar disorder

5. Montelukast (Singulair)

Asthma

Chronic obstructive pulmonary disease

6. Bupropion (Wellbutrin)

Depression

Bipolar disorder

7. Sertraline (Zoloft)

Depression

Bipolar disorder

8. Venlafaxine (Effexor)

Depression

Bipolar disorder

9. Celecoxib (Celebrex)

Joint sprain-strain

Fibromatosis

10. Lisinopril (Prinivil, Zestril)

Hypertension

Coronary artery disease

11. Duloxetine (Cymbalta)

Depression

Anxiety

12. Trazodone (Desyrel)

Depression

Sleep disturbance

13. Olanzapine (Zyprexa)

Schizophrenia

Depression

14. Epoetin alfa (Procrit, Epogen)

Chronic renal failure

Anemia from chronic disease

Source: Pharmacotherapy