Eli Lilly & Co. has been pushing for expanded use of one of its major drugs (Cymbalta) in recent months. Cymbalta is widely marketed as an antidepressant. Cymbalta is currently approved by the Food and Drug Administration (FDA) to treat depression, diabetic nerve pain, fibromyalgia, and anxiety.  The FDA does warn against a variety of potential side-effects from Cymbalta, including: increased suicide rates in younger populations, hepatoxicity, potential liver damage, effects on blood pressure, and risk of bleeding. Nonetheless, 2009 sales for the drug surpassed $3,000,000,000.00.

Eli Lilly & Co. is now seeking FDA approval for the drug's use for chronic pain.  The FDA's approval of Cymbalta for this purpose would be the first such approval of a non-traditional analgesic for treatment of chronic pain.  If approved, doctors would presumably prescribe Cymbalta more freely to treat conditions such as arthritis and back pain.  On 08/19/20, The FDA's Anesthetic and Life Support Drugs Advisory Committee voted to approve the expansion of the drug to treat pain in the broader population.  However, the panel recommended utilizing the drug for treatment of lower back pain, while voting against use of it for arthritis of the knee.

While the notion seems to be common sense, the FDA issued a statement that its approval of Cymbalta for treatment of chronic pain will result in more widespread use.  However, data comprised for 2009 revealed that two-thirds of such prescriptions were for "off label" / unapproved uses.  This data suggests the possibility that the FDA's approval of the drug to treat chronic pain may have a lesser effect than the FDA indicates is likely.

So how could this drug's approval by the FDA impact workers' compensation claimants?  I routinely see adjusters and defense attorneys arguing any plausible basis to deny authorization for medical treatment recommended by a physician.  Such a basis has certainly included a drug's / medical procedure's lack of FDA approval.  We're likely to see physicians in workers' compensation claims prescribing Cymbalta to Plaintiffs in the future on a more common basis if / when this drug obtains formal FDA approval.  As this occurs, we will encounter the additional concerns of whether it is the most appropriate drug to be utilized and the myriad of side-effects noted above.  Of course, such issues are often difficult to manage given the insurance company's right to direct medical care (pick the doctor) in a compensable workers' compensation claim.  I believe one additional benefit of a more streamlined practice is a direct, "working" knowledge of my client's treatment, which helps address some of these very issues.

Lilly Moves Closer to Approval to Market Cymbalta for Chronic Pain, The New York Times 08/19/2010