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The 4 Feared Adverse Events: What You Need to Know

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What you need to know: Antidepressants, antibiotics and statins are among the 1,731 drugs that are the suspected primary causes of four types of severe adverse drug events. While uncommon, these events can lead to life-threatening medical emergencies and irreversible damage.

What you can do: Know the drugs most commonly associated with these life-threatening adverse drug events.

Antidepressants, antibiotics and statins are among the drugs most frequently named as suspects in four distinctive and severe adverse drug events, according to a new analysis by the Institute for Safe Medication Practices (ISMP).

ISMP reviewed 1.2 million new adverse drug event reports made to the U.S. Food and Drug Administration (FDA) during 2017. The reports identified 1,731 primary suspect drugs.

The four feared adverse events

Although these four categories of resulting adverse drug events are uncommon, they can lead to life-threatening medical emergencies and irreversible damage:

  1. Rhabdomyolysis: A life-threatening condition that occurs when drugs directly or indirectly damage or destroy skeletal muscle cells, which then release such large quantities of cellular proteins that they overwhelm the kidneys’ filtering capacity to remove them. Symptoms include muscle pain, dark urine, fever, muscle cramping and vomiting. The three most common statin medications implicated were atorvastatin, simvastatin and rosuvastatin.  
  2. Serotonin or Neuroleptic Malignant Syndrome: A potentially fatal condition caused by high levels of serotonin. Symptoms include irregular heartbeat, drooling, fever, loss of normal muscle control or spastic muscle contractions, and irregular breathing. Neuroleptic malignant syndrome is a life-threatening reaction to antipsychotic drugs that occurs at normal therapeutic doses within a few days. Sixteen percent of cases resulted in death. Drugs most commonly linked to both syndromes included antidepressants, antipsychotics and opioids.
  3. Stevens-Johnson Syndrome and TEN: Severe skin disorders caused by medications or an infection. Early symptoms include flu-like symptoms followed by blisters on the face, which extend to skin lesions all over the body. Mortality rates range from 12 percent to 49 percent, depending on the severity. The top-most reported medications are lamotrigine; combined sulfamethoxazole and trimethoprim; allopurinol, ibuprofen and acetaminophen.
  4. Progressive Multifocal Leukoencephalopathy: A deadly viral infection of the brain. Symptoms include general weakness, changes in behavior and visual disturbances. A total of 419 cases were reported, with a fatality rate of 29 percent. The drugs most commonly implicated were natalizumab, rituximab, fingolimod and mycophenolate.

ISMP urges rapid diagnosis, identification, and cessation of suspect drugs to treat the four disorders.

For more information

Read ISMP’s Quarter Watch.

(Content provided by: Comprehensive Pharmacy Services)