(June 5, 2012) – The anti-depressant Cymbalta (duloxetine) is the first drug that has been shown to relieve the nerve pain and discomfort that affects up to one third of cancer patients treated with certain chemotherapy drugs, researchers report.
In a study of more than 200 people who suffer from the condition known as chemotherapy-induced peripheral neuropathy, 59 percent of those given Cymbalta reported a decrease in pain, compared with 39 percent given placebo.
Chemotherapy-induced peripheral neuropathy is caused by damage to nerves, most often in arms and legs. Besides shooting pain, symptoms include burning, tingling, numbness, problems with balance, dropping things, and cold and heat sensitivity.
“Peripheral neuropathy is a chronic, debilitating problem, with some patients enduring pain, numbness, and tingling for months, possibly years, after completion of chemotherapy,” says researcher Ellen M. Lavoie Smith, Ph.D., an assistant professor in the School of Nursing at University of Michigan, Ann Arbor.
“Until now, we knew of nothing that was effective in treating the condition,” she said. The drug was generally “well tolerated.” The most common side effect was mild fatigue, reported by 11 percent of people taking Cymbalta and 3 percent on placebo. Twelve patients (11%) dropped out of the study due to drug associated side effects.
Cymbalta is thought to work by changing levels of brain chemicals linked to pain and nerve function. Cymbalta, which is approved for the treatment of depression and painful diabetic peripheral neuropathy, costs about $150 for a one-month supply.
This is great news for patients being treated with chemotherapy drugs. However, Cymbalta has been classified as “Do Not Use” for any form of depression, as well as for all other uses for which it has been approved (such as generalized anxiety or any form of pain, including fibromyalgia). The conclusion that duloxetine should not be used for any purpose also was reached in February 2009 by Prescrire, the French journal of drug safety and efficacy, which stated, “Duloxetine: to be avoided in all circumstances.”
The FDA issued a Black Box Warning, which is the strongest type of safety alert the FDA can demand of drug manufacturers, and can be required when there is evidence of serious injuries or death with a drug.
Liver toxicity and liver failure, sometimes fatal, have been reported in patients treated with duloxetine.
On October 17, 2005, Eli Lilly expanded its warning about potential liver-related problems with Cymbalta and cautioned doctors against prescribing it to patients with chronic liver disease, U.S. health regulators announced. The new label for the drug also contained reports of hepatitis, jaundice, and other liver-related problems in patients using Cymbalta.
Soon thereafter, the FDA had issued a warning about the potential for suicidal thinking in adults taking anti-depressants, but the agency specifically singled out Cymbalta because of a higher than expected rate of suicide attempts in recent studies. Cymbalta was a relatively new anti-depressant manufactured by Eli Lilly that had been associated with suicide risk since its clinical trials.
The warning came after a review of Cymbalta by Eli Lilly, which found that 11 of nearly 9,000 women taking it for urinary incontinence tried to commit suicide. The fact that these patients were suffering from urinary incontinence and not depression is significant because the drug companies have long argued that anti-depressants are used by depressed people who have a higher likelihood of committing suicide.
Cymbalta has been associated with suicidal behavior since Traci Johnson, a healthy volunteer involved in a trial at Eli Lilly’s clinic at Indiana University Medical Center in Indianapolis, killed herself in one of the clinic’s showers. She did not suffer from depression and was taken off the drug and given a placebo four days before she hung herself in the clinic’s showers on February 7, 2004. She was the 5th patient to commit suicide after taking Cymbalta in clinic trials. After her death, 1/5 of the volunteers quit the Cymbalta trial.
Many patients who have been treated with Cymbalta today complain that it is almost impossible to go through the withdrawals of this drug. It makes them feel so sickly, some complaints are of “brain surges” or “zaps” that cause dizziness and a shock like feeling. Some patients say this drug should be illegal. There are several complaints of feeling emotionless, gaining weight even though the side effects state “possible weight loss”, making your heart feel like it is coming out of your chest, constant nightmares, and some complaints of manic behavior. There are many that say that after taking just one Cymbalta pill they experienced terrible side effects that took weeks to dissipate. One woman stated that her husband could not take the horrific side effects and his doctor was of no help, so he put a gun to his heart and killed himself.
There is currently a Cymbalta Petition , which is demanding that Eli Lilly make the consumers aware of all the terrible side effects and withdrawal complications patients in the U.S., as well as worldwide, have experienced since taking this medication. It is still not taken off the market and no changes have been made.
If Eli Lilly was aware of these terrible side effects, why haven’t the physicians and the consumers been made aware of them? Why is this drug still on the market?
So, even though this medication may relieve the pain and discomfort caused by chemotherapy-induced peripheral neuropathy, are these horrible side effects really worth it? Before these cancer patients are given this “wonder drug,” they are entitled to the risks this drug can cause, after all, haven’t they been through enough?