Quoted from http://www.boston.com/business/healthcare/articles/2010/05/26/2_drugs_suicide_warnings_toughened/
2 drugs’ suicide warnings toughenedBloomberg News / May 26, 2010
WASHINGTON — Johnson & Johnson strengthened warnings about the risk of suicide with its Ultram and Ultracet painkillers after deaths were reported in patients who have histories of emotional disturbance or drug abuse.
The medicines, which contain the opioid tramadol, may be more potent when combined with alcohol, different painkillers, or drugs that depress the central nervous system, J&J told doctors in letters released yesterday by the Food and Drug Administration.
The company did not say how many deaths were reported.
J&J recommended caution when giving Ultram and Ultracet to people on tranquilizers or antidepressants, and those who have depression or drink too much.
The drugs should not be used in patients who are suicidal or prone to addiction, according to the new bold-faced warning in the prescribing information.
“The judicious prescribing of tramadol is essential to the safe use of this drug,’’ according to the letter, dated in March, from the PriCara division of Ortho-McNeil-Janssen Pharmaceuticals Inc., a subsidiary of New Brunswick, N.J.-based J&J.
J&J, the world’s largest maker of health care products, did not disclose sales of Ultram or Ultracet in its annual report.
J&J revised recommendations in the drugs’ prescribing information and issued the letters to doctors “after consultation with the FDA and ongoing discussions regarding the risks and benefits,’’ William Foster, a company spokesman, said yesterday.
The company’s shares fell 22 cents, or less than 1 percent, to close at $60.35 yesterday in New York Stock Exchange composite trading.