Darvocet® & Darvon® Recall
Darvon® and the related drug Darvocet® are mild to moderate pain relievers that were both pulled from the market in November 2010 because they were found to be causing potentially life-threatening heart problems. The medications also were linked to unacceptably high rates of overdoses and suicides.
Darvon® is propoxyphene and Darvocet® is propoxyphene combined with acetaminophen. The drugs had been on the market for a long time. Darvon® was approved by the U.S. Food and Drug Administration (FDA) on Aug. 8, 1957. Darvocet® received FDA approval 14 years later.
Dangers of Darvon® and Darvocet®
The dangerous ingredient in both drugs is propoxyphene. A study required by the FDA showed a prolonged QT interval on the electrocardiograms of some propoxyphene users. Prolonged QT intervals indicate heart arrhythmias (abnormal heart rhythms) that could lead to death. This heart problem even showed up in healthy subjects who were taking propoxyphene at prescribed doses.
The risk of this problem can be increased in patients with altered disease states, patients who use certain other medications, or patients with decreased kidney function. Loss of kidney function could mean that the patient cannot not sufficiently clear the drugs from the body.
Darvon® and Darvocet® Black Box Warnings
Prior to the recall, the labels on Darvon® and Darvocet® carried a black box warning about overdosage and death. A black box surrounding a warning is the strongest type of caution a drug manufacturer can put on a drug label. According to reports, there were numerous cases of accidental and intentional overdoses in patients using propoxyphene alone or in combination with other central nervous system depressants, which include alcohol.
In bold black letters the black box warning emphasized that "fatalities within the first hour of overdosage are not uncommon." The label explained that propoxyphene is dangerous in patients with suicidal ideation with previous histories of emotional disturbances or suicide attempts.
It also noted that it is dangerous in patients taking central nervous system (CNS) depressants such as:
- Muscle relaxants
- Antidepressant medications
The black box emphasized to the physician: Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation.
After discovering that the drugs increased the risk of serious heart problems, the FDA determined that the benefits of the pain medications no longer outweighed the risks. Both Darvon® and Darvocet® were recalled in 2010.
Contact an Attorney for Darvocet® and Darvon® Injuries
If you or a loved one has suffered from heart complications or other serious, life-threatening side effects after taking Darvon® or Darvocet®, you should speak with an experienced Darvocet® attorney about your rights. You might be eligible to recover financial compensation for your pain and suffering as well as your medical bills. To schedule a free case review, please contact Flood Law Group today.
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