As a dangerous prescription medication lawyer, I often see reports of drug makers seeking the U.S. Food and Drug Administration’s approval to sell their medications for different illnesses than the ones the drugs were developed to treat. Recently, drug maker Eli Lilly asked the FDA to allow it to sell its antidepressant Cymbalta (duloxetine) as a treatment for chronic pain. Since I spend a lot of time helping patients who have been hurt by dangerous prescription medications, as a pharmaceutical liability attorney, I’m concerned about Cymbalta’s use by more patients, since the drug has been connected with serious risks like liver damage and skin disease.
Lilly wants to market Cymbalta for use by patients with chronic pain related to arthritis and lower back pain — a large number of Americans, as noted in the article by Dr. Bob Rappaport, the FDA’s director of the Division of Anesthesia and Analgesia Products. This would clearly be a boon for Lilly’s profits because it would expand the pool of potential customers. And for drugs that don’t have any serious side effects, expanding their use for patients who have different illnesses can be an efficient way to help more people feel better and get well. Cymbalta’s reach has already expanded to encompass not only depression but also fibromyalgia, anxiety and pain associated with diabetic neuropathy. Most Cymbalta users are being treated for depression, but 14% are being treated for pain. Prescriptions for Cymbalta nearly tripled from 2005 to 2009, from 5 million to over 14 million.
While Cymbalta is already being prescribed to treat pain, FDA reviewers are not completely convinced by Lilly’s evidence that the drug is effective for that purpose. They have pointed out flaws in the design of Lilly’s studies that found the drug to be effective. Further, the FDA recently scolded Lilly for making false and misleading claims about Cymbalta’s effectiveness against pain, and understating the drug’s risks in its marketing materials. The drug carries a number of minor side effects, but among its serious ones are Stevens-Johnson syndrome and toxic epidermal necrolysis, two forms of life-threatening skin disease that develop as a drug reaction and usually require hospitalization. The FDA is also worried about other risks that are already included in Cymbalta’s labeling, such as serious liver toxicity, and suicidality in children, adolescents and young adults taking Cymbalta for depression or other psychiatric disorders.
The FDA and doctors need to be vigilant about expanding the reach of drugs that aren’t as safe as we might hope. Users of Cymbalta face serious risks, which will inevitably become more widespread as more people take this medication, and new serious risks may be discovered as well. Earlier this summer, I wrote about the potential for Cymbalta to cause terrible birth defects, premature delivery, and miscarriage. If Cymbalta is to be approved for marketing to more patients for more conditions, I hope the FDA carefully considers how to make sure patients are properly warned of all the risks they face. At the same time, the FDA isn’t the only one responsible for making sure patients know what they’re getting into. Drug manufacturers like Lilly have a legal duty to warn consumers and the FDA about risks that their products might pose. If Lilly knows that its studies of Cymbalta’s efficacy for pain are faulty and is trying to expand its markets while putting patients at risk for serious side effects, patients could be hurt. Those patients could sue Lilly to recover the costs of their medical treatment, along with compensation for pain and suffering, loss of quality of life and past and future wages.
The defective medication lawyers at Carey, Danis & Lowe help people who have been hurt by defective drugs. If you or someone you love has been seriously harmed by a prescription or over-the-counter medication, we can help you recover compensation from the company that caused your injury. In this type of claim, you can recover all of your family’s medical expenses, lost wages, permanent injuries and pain and suffering caused by the defective medication. The law recognizes that you should not have to bear those costs if they were imposed upon you through no fault of your own, and we can help you set things right. To learn more about your rights and your legal options, please call Carey, Danis & Lowe for a free consultation, toll-free, at 1-877-678-3400 or contact us through our website.