Olanzapine Safety Alert issued by FDA
The US Food and Drug Administration (FDA) has issued a warnings of rare skin conditions associated with the popular antipsychotic drug Olanzapine. Olanzapine, also sold under the brand names Zyprexa, Zyprexa Zydis, Zyprexa Relprevv and Symbyax has been linked to a severe condition known as drug reaction with eosinophilia and systemic symptoms (DRESS). A search conducted by the FDA Adverse Event Reporting System (FAERS) database recently found an astounding 23 cases of DRESS correlated with Olanzapine worldwide since its first release in 1962. Additionally, the FDA notes that these cases were only limited to reports submitted to the agency, therefore, there may be further cases of which the FDA is unaware.
What is DRESS?
DRESS is a rare but severe skin reaction that can often progress to affect other parts of the body. At first it may simply start out as a rash spread out through the body. However, it can progress to excruciating symptoms of a fever, swollen lymph nodes and swelling in the face. Additionally, the side effects can result in injury to crucial organs such as the liver, kidneys, lungs, heart or even the pancreas. With a mortality rate of up to 10%, it is obvious that DRESS can lead to fatal injuries or death.
Consequently, the FDA recommends that if DRESS is suspected, physicians should immediately discontinue the treatment of Olanzapine. Currently, there is no specific methods of treatment for DRESS. Early recognition of the symptoms associated with DRESS are crucial for management.
Furthermore, the FDA released a Drug Safety Communication about two deaths following an injection of Zyprexa. The study revealed one of most serious warnings released by the FDA linking medications containing Olanzapine with post-injection delirium sedation (PDSS). However, due to the fact the study results were inconclusive, the FDA suggested that patients should not stop receiving treatments prior to speaking with their health care professional. Nonetheless, the FDA did recommend that the drug’s manufacturer, Eli Lilly and Company, conduct an “animal study to test whether movement of olanzapine into blood after death could lead to higher-than-expected blood levels of the drug.”
Patients should be alert for symptoms of drowsiness, dizziness, confusion, disorientation, trouble with speech, and weakness when receiving Zyprexa treatment. This is not the first time that the manufactures of Olanzapine received concerning reviews on their products. It is safe to say that caution should be used when using olanzapine containing medications as treatment.