Luvox – Side Effects, History & Removal From The Market
Luvox (fluvoxamine maleate) is an SSRI (selective serotonin reuptake inhibitor). It has been primarily used to treat Obsessive Compulsive Disorder (OCD) and Social Anxiety Disorder (SAD).
The drug, Luvox is marketed under the names:
- Luvox
- Luvox CR
- Fluvoxamine
- Fluvoxamine Maleate
Luvox CR, manufactured by Jazz pharmaceuticals, has recently come under fire from the FDA for it deceptive marketing practices . In 2010, the FDA warned Jazz Pharmaceuticals that a patient brochure for Luvox CR was “false or misleading” because it suggested that Luvox was “safer and more effective than has been demonstrated.”
Side effects associated with Luvox
Persistent Pulmonary Hypertension (PPHN) is a life-threatening lung condition apparent soon after birth. Babies exposed to SSRIs after the 20th week of pregnancy have six times the risk of developing PPHN. PPHN babies cannot get enough oxygen into their bloodstream. This can cause heart failure, seizures, organ failure, hearing loss, brain damage, kidney damage, shock and even death.
Suicide–Research shows that people under the age of 25 who take antidepressants have a higher risk of suicide than do adults [1]. As a result, the FDA requires the labels of antidepressants used by children to include a tough “black box” warning about this risk.
Most antidepressants have never been specifically approved for use in children and adolescents who suffer from depression. Nevertheless, they are regularly prescribed to young persons.
Neuroleptic Malignant Syndrome or Serotonin Syndrome These conditions are treatable if caught early but if allowed to continue, can result in death. Symptoms for these conditions include:
Suicide–Research shows that people under the age of 25 who take antidepressants have a higher risk of suicide than do adults [1]. As a result, the FDA requires the labels of antidepressants used by children to include a tough “black box” warning about this risk.
Most antidepressants have never been specifically approved for use in children and adolescents who suffer from depression. Nevertheless, they are regularly prescribed to young persons.
Neuroleptic Malignant Syndrome or Serotonin Syndrome These conditions are treatable if caught early but if allowed to continue, can result in death. Symptoms for these conditions include:
- Fever
- Confusion or delusional thinking
- Excessive sweating
- Rigid muscles
- Unstable vital signs (rapid heart beat, fluctuating blood pressure)
- Coma
History and Removal from the Market
Luvox is the brand name of the generic medication fluvoxamine maleate. It was developed by Solvay Pharmaceuticals and marketed in the United States in 1994. Luvox was used to treat obsessive-compulsive disorder (OCD). It helped decrease persistent thoughts and urges to perform repeated tasks (compulsions such as hand-washing, checking, and counting) that interfere with daily life. Luvox was also used to treat depression, panic disorders, phobias, and eating disorders.
The active ingredient in Luvox was fluvoxamine. This ingredient acted as a selective serotonin reuptake inhibitor (SSRI) and increased the serotonin’s cellular connection. Serotonin is a naturally occurring substance that acts as a neurotransmitter and affects most brain cells. Serotonin is connected to functions like emotions, mood, sleep, and memory. SSRIs block the reabsorption of serotonin into neurons. This makes more serotonin available to improve transmission of messages between neurons.
The risk factors associated with Luvox included nausea, vomiting, insomnia, abdominal pain, weight gain, weight loss, constipation, and diarrhea. Luvox contained an additional warning as it was believed to be associated with violent behavior and suicidal thinking in children and teenagers.
Luvox was removed from the US market in 2002 following press coverage related to the Columbine Massacre in 1999. Eric Harris, one of the killers, was rejected by the military because of his Luvox usage. After the shooting Dr. Peter R. Breggin, a Harvard trained psychiatrist whose work provided the foundation for modern criticism of psychiatric diagnoses and drugs, claimed that the psychiatric medications prescribed to Harris may have exacerbated his aggression due to the fluvoxamine-induced stimulation. Harris had been taking this medication for approximately one year prior to the massacre. According to reports, Eric Harris had a “therapeutic blood level” of fluvoxamine at the time of his autopsy.
In 2008, after reformulation and FDA approval, Luvox CR was introduced to the US market. Luvox CR is the controlled-release version of Luvox that is manufactured by Jazz Pharmaceuticals. Luvox CR contains a black box warning relating to suicidal thoughts or action in children, teens, and young adults who take the medication. In short-term studies, SSRIs increased the risk of suicidality in children, adolescents, and young adults when compared to placebo. Short-term studies did not show an increased risk of suicidality when compared to placebo in adults beyond the age of 24. Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s health care professional.
If you, your child or loved one has been injured by Luvox, the manufacturer may have failed in its duty to design, make, inspect and label the product appropriately.
Do not stop taking a prescribed medication without first consulting your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death.
Jazz Pharmaceuticals has voluntarily removed Social Anxiety Disorder as in indication for Luvox CR, and is no longer permitted to market Luvox CR for SAD.
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022033s003,s006,s007ltr.pdf
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm219014.htm