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FDA Warns About Serious and Potentially Fatal Skin Reactions With Anti-Psychotic Medication Olanzapine

Thursday, May 12th, 2016

On Tuesday May 10, 2016, the U.S. Food and Drug Administration (FDA) issued a warning to healthcare professionals and patients regarding the mental health drug olanzapine, which is used in popular anti-psychotic medications such as Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax. The FDA warning concerns the ability of olanzapine to cause a serious and potentially fatal drug reaction that begins with a serious skin reaction and then progresses to affect other parts of the body, including major organ systems like the heart, kidney, and liver.

The reaction, known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), often begins with skin rash and swollen lymph glands, or swelling in the face. The FDA advised patients on olanzapine to immediately seek medication attention if they develop these symptoms. The agency also advised healthcare professionals to explain the signs and symptoms of severe skin reactions to their patients and instruct them when to seek medical care when prescribing drugs containing olanzapine.  Olanzapine is an anti-psychotic medication used to treat schizophrenia and bipolar disorder.

DRESS can start as a rash that spreads to the entire body, and can also include fever, swollen lymph nodes, and swollen face. The reaction produces a higher-than-normal number of white blood cells called eosinophils, which are used to fight infections, leading to inflammation and swelling.  DRESS can ultimately cause serious injury to major organ systems, including the liver, kidney, lungs, heart or pancreas, and can be fatal.

The FDA issued the warning after analyzing reports in its drug safety database which tracks adverse reactions associated with various medications that are reported to the agency. The FDA found 23 cases of DRESS reported with the use of olanzapine worldwide since the drug was first approved in 1996. However, since many drug induced adverse reactions are not reported to the agency, the FDA believes that the actual number of cases of olanzapine induced DRESS is likely far higher.  You can read the entire FDA Safety Alert for olanzapine here: http://www.fda.gov/Drugs/DrugSafety/ucm499441.htm.

The information that the FDA based its decision to warn about DRESS on all medications containing olanzapine was equally available to manufacturers of these drugs. Federal regulations require drug manufacturers to monitor the safety of their products and implement additional warnings regarding adverse reactions associated with their drugs. While the FDA is tasked with ensuring all prescription and non-prescription drugs prescribed in the U.S. are safe and effective, it lacks the resources to actively monitor the more than 5,000 drugs in the U.S. marketplace.  This is why federal law requires drug makers to routinely submit safety information about their products to the FDA once they are approved for sale. However, many drug companies often choose to wait for the FDA to require additional warnings of adverse reactions for their products so as not to deter physicians from prescribing them to their patients, thereby putting profit over the safety of patients who use their drugs.

The Law Offices of Brian D. Witzer has extensive experience representing patients who have been injured by defective drugs and medical devices, and have routinely gone up¬†against some of the largest pharmaceutical and medical device manufacturers in the world. Our firm has unique, specialized experience in representing consumers who have developed DRESS from a variety of medications. The firm was the first in the U.S. to successfully sue the manufacturer of a popular prescription acne medication for failing to timely warn that its product could cause DRESS in patients. Our clients’ teenage daughter was prescribed the medication for moderate acne, which at the time did not include warnings of DRESS. Their daughter eventually developed DRESS and after several months in the hospital, tragically succumbed to the reaction after it caused major damage to her heart. ¬†After this incident, the FDA required warnings of DRESS on the drug’s labeling. The attorneys at our firm were able to prove that the information that led to the FDA mandated warnings had been available to the drug’s manufacturer for several years before our clients’ daughter was prescribed the medication.

If you or a loved one has experienced DRESS as a result of taking mental health medications such as Zyprexa or Symbyax, contact the attorneys at the Law Offices of Brian D. Witzer for a free consultation to discuss your legal rights.


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