Johnson & Johnson strengthened the warnings concerning the risk of suicide with painkillers Ultram and Ultracet after deaths were reported in patients with a history of emotional disturbance or drug and substance abuse. Ultram and Ultracet are indicated for the management of moderate to moderately severe chronic pain. In letters released yesterday by the U.S. Food and Drug Administration (“FDA”), J&J has informed doctors the Prescribing Information for the drugs has been updated to explain that the active ingredient, opioid tramadol, contained within the drugs may be more potent when combined with alcohol, different painkillers or drugs that depress the central nervous system.
These warnings describe and emphasize the risks of suicide in patients who are addiction-prone, and taking tranquilizers or antidepressant drugs. Further, tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids or illicit drugs that cause depression, which can lead to accidental overdose, the effects of which can include CNS depression, respiratory depression and death.
Accordingly, J&J now recommends in bold faced print that healthcare providers use extreme caution when giving Ultram and Ultracet to depressed patients, to those on tranquilizers or antidepressants, or to those who drink excessive alcohol. Additionally, J&J specifically states that the drugs should NOT be prescribed to patients who are suicidal or prone to addiction.
This news comes only several weeks after J&J was forced to into a massive recall of over 40 varieties of children’s cold medicines (including infant Tylenol, Benadryl and Motrin) after finding quality control problems at a plant in Pennsylvania including bacterial contamination and higher than expected dosages in the medication.
If you have any questions regarding these updated warnings, recalls, or any other adverse drug related side-effects, please contact Pogust, Braslow and Millrood for more information.