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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).

It 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.”

So what are some of the dangers associated with Luvox?

Birth defects 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:

  • Fever
  • Confusion or delusional thinking
  • Excessive sweating
  • Rigid muscles
  • Unstable vital signs (rapid heart beat, fluctuating blood pressure)
  • Coma

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.

At Brown & Crouppen our experienced team of defective drug lawyers provide tough, aggressive representation for victims and their families. Brown & Crouppen can help you make informed decisions about your legal rights, so please call Brown & Crouppen at Toll Free: 800-536-4357 for your free legal consultation or save time with our online Contact Form.


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

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