Serzone, an antidepressant drug marketed as a safer alternative to antidepressants such as Prozac, Paxil, and others, has been shown to carry its own unique risks, some deadly.
Approved by the FDA in 1994, Serzone’s market niche consisted in part of those who considered the risks of other antidepressants to be too great.
Serzone had little sexual side effects, and caused less weight gain than similar medications.
Unfortunately, many patients who chose Serzone (generic name nefazodone hydrochloride) were not aware of other, even more serious side effects including irreversible liver damage (hepatic failure) and death.
In the US alone, 55 cases of Serzone-related liver failure were reported, including at least 21 that resulted in death. In 2001, the FDA issued a directive requiring a black box warning—the strongest type of warning that can be required for a prescription medication—warning of the potentially serious effects on liver function.
The rate of liver failure among those using Serzone was estimated at about three to four times the rate of those not using the drug, although these figures are generally considered to be lower than the actual rate of liver damages attributable to Serzone, due to underreporting.
The consumer advocacy group Public Citizen sued the FDA in 2004, calling its failure to ban the drug “a shame,” and arguing that the FDA failed in its duty to “protect public safety and prevent needless death and injury” by allowing Serzone to remain on the market despite knowledge of the devastating and frequently deadly side effects of the drug.
Serzone was finally taken off the US market in 2004. Before that, it had been taken off the market in Australia, New Zealand, Europe, and Canada because of safety concerns.
Other Serzone Side Effects
Although liver failure is arguably the most serious side effect of Serzone, there are other side effects associated with the drug as well, including:
- Seizures
- Headaches
- Dry mouth
- Hypotension
- Drowsiness
- Insomnia
- Fatigue
- Agitation
- Constipation
- Nausea
- Confusion
- Dizziness
- Lightheadedness
Over 15% of patients taking Serzone stopped their use of the drug as the result of these and other side effects.
Why Serzone’s Withdrawal is Not Enough
Bristol Meyers, the manufacturer of Serzone, claimed that its withdrawal of Serzone from the US market was done for commercial reasons, denying that the potential for death and serious liver damage played a role in their decision.
The company did acknowledge that the withdrawal from the Canadian market was due to the increasing number of deaths and serious liver damage that were attributable to the drug.
So, while Bristol Myers did withdraw Serzone from the market, they did not recall the drug, and the FDA approval of the drug was unchanged, allowing generic nefazodone hydrochloride to remain on the market and to be approved in the future.
Hundreds of lawsuits have been filed against Serzone’s makers, demanding compensation for Bristol Myers’ role in the damages suffered by patients and their families, and lawsuits continue to be filed.
If You or a Family Member was Injured
If you or someone you love suffered from liver failure, liver damage, or other debilitating effects of Serzone, you owe it to yourself and to your family to consult with an experienced attorney practicing pharmaceutical law.
He or she can review your case with you, help you understand your rights, and advise you how you can best pursue getting the compensation you and your family need and deserve.
Click here for detailed information on pharmaceutical injury law.
