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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: nefazodone (ne FAZ ah done)
Brand name(s): SERZONE
GENERIC: available FAMILY: Other Drugs for Depression
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

Nefazodone caused harm in animal studies, including decreased pup weights and deaths in pups after birth. Because of the potential for serious adverse effects to the fetus, this drug should not be used by pregnant women.

Breast-feeding Warning

No information is available from either human or animal studies. However, it is likely that this drug, like many others, is excreted in human milk, and because of the potential for serious adverse effects in nursing infants, you should not take this drug while nursing.

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING

Suicidality and Antidepressant Drugs

Compared with placebo, antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder and other psychiatric disorders. Anyone considering the use of nefazodone or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared with placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

Nefazodone is not approved for use in pediatric patients.

OTHER IMPORTANT WARNINGS

Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE. The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000–300,000 patient-years of Serzone treatment. The total patient-years is a summation of each patient’s duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc.

Ordinarily, treatment with SERZONE should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.

Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur. SERZONE should be discontinued if clinical signs or symptoms suggest liver failure. Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels .5 (greater than or equal to) 3 times the upper limit of NORMAL, while on SERZONE should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if SERZONE is reintroduced. Accordingly, such patients should not be considered for re-treatment.[1]

Facts About This Drug [top]

Nefazodone (SERZONE) was cleared for marketing as an antidepressant by the Food and Drug Administration (FDA) in December 1994. We list this drug as a Do Not Use drug because it causes liver failure.

For patients who need an antidepressant drug, we recommend trying one of the newer selective serotonin reuptake inhibitors (SSRIs) (for example, fluoxetine [PROZAC, SARAFEM, SELFEMRA]) first, as these are the safest antidepressants. If symptoms do not improve sufficiently with use of an SSRI...

Nefazodone (SERZONE) was cleared for marketing as an antidepressant by the Food and Drug Administration (FDA) in December 1994. We list this drug as a Do Not Use drug because it causes liver failure.

For patients who need an antidepressant drug, we recommend trying one of the newer selective serotonin reuptake inhibitors (SSRIs) (for example, fluoxetine [PROZAC, SARAFEM, SELFEMRA]) first, as these are the safest antidepressants. If symptoms do not improve sufficiently with use of an SSRI and remain severe, further treatment with other antidepressants is warranted.

Regulatory actions surrounding nefazodone

2001: On December 10, 2001, the FDA informed nefazodone’s manufacturer that it must add a black box warning (see above) to the professional product label (package insert) for the drug informing doctors and pharmacists that life-threatening liver damage can occur with the use of nefazodone. A black box warning is the strongest type of warning that the FDA can require on a drug label. This action followed a warning issued by Canadian government authorities earlier in 2001.

2003: Nefazodone’s manufacturer announced on January 8, 2003, that it was pulling the drug in all European countries where it was marketed. The drug was pulled from the Swedish market in early 2002 and taken off the shelves in Denmark in December 2002 after concerns about liver toxicity. Nefazodone had been linked to liver failure and/or death in 26 patients worldwide.

Public Citizen’s Health Research Group petitioned the FDA on two separate occasions in 2003, asking the regulatory agency to remove this dangerous drug from the market.[2],[3]

2004: Although, following litigation brought by Public Citizen against the FDA in 2004, Bristol-Myers Squibb removed their brand name version of the drug from the market, it continues to be sold by generic companies. In October 2004, the FDA issued a public health advisory requiring manufacturers to add a black box warning (see above) to its professional product labeling (package insert) of all antidepressants. A black box warning is the strongest type of warning that the FDA can require. The FDA also requires that a Patient Medication Guide be given to patients receiving this drug advising them of the risk and precautions that can be taken.

2007: The FDA announced in May 2007 that it will require new warnings concerning the increased risk of suicidal thoughts and behavior in young adults ages 18 to 24 during the first one to two months of treatment with antidepressants. The agency wants the new warnings to be black box warnings printed on the professional product labels for all antidepressants sold in the U.S. The warning is an amendment to an existing black box warning for children and adolescents.[4]

last reviewed January 31, 2021