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FDA Updates Antidepressant Warning Label to Include Risk of Sudden Cardiac Death

By December 9, 2009July 17th, 2019Dangerous Drugs

As a pharmaceutical liability attorney, I was disturbed to read about a new warning of serious side effects for the antidepressant Norpramin (desipramine hydrochloride). According to a Dec. 2 article from Medscape, the FDA and drug manufacturer Sanofi-Aventis have made significant changes to the warning label on Norpramin to reflect a risk of serious heart problems in patients taking the drug. The label now advises health care professionals to use extreme caution when prescribing Norpramin to patients with a family history of sudden cardiac death, arrhythmia (a heartbeat that’s too slow, too fast or not regular) or cardiac conduction disturbances.
Norpramin (sold as Pertofrane outside the U.S.) is primarily used for treating depression, but also in patients with nerve pain, cocaine withdrawal or attention deficit disorder. It is part of the tricyclic class of antidepressants, which were widely used until the introduction of the newer selective serotonin reuptake inhibitors. Along with the warning on heart problems, the FDA letter announcing the labeling changes (PDF) added a general warning to health care professionals that some patients who suffered death and cardiac arrhythmia have suffered seizures beforehand. Because an overdose of Norpramin has shown a higher risk of death than overdoses of other tricyclic antidepressants, the label also included specific instructions for doctors to treat overdose patients. Finally, the label changes deleted previous treatment advice that narrowed doctors’ options for treating an overdose.
As a dangerous drug lawyer, I hope doctors and patients take quick action on this warning. Prior to this announcement, the primary known safety problem with Norpramin (and other tricyclic antidepressants) was a heightened risk of depression, particularly in children. With this announcement, it appears that adults with a family or personal history of heart problems, a very different group, may have been lulled into a false sense of security. The FDA letter did not say how it and Sanofi-Aventis discovered the elevated cardiac risks, but as a rule, major safety changes like this are announced only after multiple reports of patient safety problems or new scientific studies. That means the chances are good that thousands of patients were unknowingly exposed to the cardiac risks of Norpramin. And because overdose of tricyclic drugs is a significant drug poisoning problem — British and Australian studies found that 8 to 12 percent of drug overdose deaths were from tricyclic antidepressants — the risk of death may be greater still.

Based in St. Louis and Belleville, Ill., the Lowe Law Firm represents people around the United States who suffered serious health consequences or even death from taking a medication they thought they could trust. Drug manufacturers have a legal obligation to provide products that are safe to use as directed, but as recent history shows, many have failed in that duty, with catastrophic results for patients. In fact, investigations have found that some pharmaceutical companies have even tried to cover up negative information about their drugs in order to protect their profits. Our defective pharmaceutical attorneys believe patients’ health should always come first, and that drug makers should be held legally and financially responsible for actions that hurt their customers. We help families that have suffered a death, serious illness or injury to collect compensation for all of their medical costs, their injuries and any death or disability.
If you or someone you love was hurt by taking a prescription drug, don’t hesitate to call the Lowe Law Firm to tell us your story and learn how we can help. To set up a free, confidential evaluation of your case, please contact us online or call toll-free at 1-877-678-3400 today.