FDA Warns That New Pain Reliever Can Be Addictive

The popular new prescription pain reliever Ultram can cause addiction or seizures in certain patients and must be used with caution, the Food and Drug Administration warned doctors Wednesday.

Known chemically as tramadol, the drug was approved just a year ago but already has been used by 5 million patients suffering chronic pain, anything from back problems to broken bones. But the FDA has received 115 reports of patients who became dependent on tramadol or abused it, sometimes intentionally overdosing.

Also, doctors told the FDA about 83 patients who suffered seizures while using Ultram, usually when they took it together with certain other medicines, including the antidepressant Prozac.

So the FDA and manufacturer Ortho-McNeil Pharmaceutical wrote 900,000 doctors, dentists and other health care providers that Ultram should not be prescribed to patients taking certain drugs that affect the brain, like some antidepressants. Prescribing it to patients with certain neurological disorders may increase their risk of convulsions, the agency said.