Cymbalta usage extended

CymbaltaEli Lilly’s blockbuster antidepressant Cymbalta (duloxetine hydrochloride) has received expanded approval from the U.S. Food and Drug Administration to treat chronic musculoskeletal pain, stemming from conditions including lower back pain and osteoarthritis.

Since its approval as an antidepressant in 2004, some 30 million people in the United States have used the drug. Chronic musculoskeletal pain is the fifth indication the agency has granted for the drug.  The US regulator also has sanctioned Cymbalta for the treatment of diabetic pain, generalized anxiety disorder and fibromyalgia.

It is already used ‘off-label’ for a range of conditions such as musculoskeletal problems, headaches and nerve pain, noted the FDA, which assessed the efficacy of Cymbalta in chronic low back pain and osteoarthritis in four trials involving 600 patients. At the end of the study period, patients taking Cymbalta had a significantly greater pain reduction compared with placebo.

The most common side effects from Cymbalta use include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. More serious adverse reactions have included liver damage, allergic reaction, pneumonia, depressed mood, and suicidal thoughts and behavior, the agency said.

The FDA has also warned that Cymbalta should never be used in patients who have recently taken a type of antidepressant called an MAOI, or Mellaril (thioridazine), or who have uncontrolled glaucoma.

The approval comes after the FDA’s Anesthetic and Life Support Drugs Advisory Committee voted 8-5 in favour of expanding the pain indication but 4-9 against supporting its use to treat osteoarthritis, concerned about the known serious side effects associated with the drug. These include liver damage, allergic reactions, pneumonia, depressed mood, suicide and suicidal thoughts.