[Pain Management] FDA Clears Cymbalta To Treat Chronic Musculoskeletal Pain

[Justin]

The U.S. Food and Drug Administration approved Cymbalta (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Cymbalta was first used to treat major depressive disorder in 2004. "Up to three quarters of the population experience chronic pain at some time in their lives," said Janet Woodcock, M.D.....

FDA Clears Cymbalta To Treat Chronic Musculoskeletal Pain (click here for the full article at Medical News Today)

[Jack-of-all-trades]

I'm really kind of sad that Cymbalta got this indication. It's not that it might not be somewhat beneficial, it's just that it doesn't, in my opinion, pass the cost/benefit analysis and I'm not talking money. I can see practitioners prescribing this in lieu of honest pain controlling drugs in an attempt to get away from controlled medicine. The drug reps po-po some of the side effects as insignificant. A psychiatrist friend told me that up to 50% of the people he puts on SNRIs (Cymbalta, Effexor, and the new on Prestiq), end up with noticeable side effects. Prestiq is just enough different chemically to get a new patent but all three are quite similar. Withdrawal is so horrific for most people that they end up on some form of SSRI for life. Depression is the proper use for these drugs. There are much better drugs out there for pain and anxiety.

I'm sure Cymbalta will be able to sell a ton of this to poorly informed practitioners trying to deal with chronic pain without resorting to opiates. Drug reps will be sampling heavy for those clinics that still allow sampling. There will be an incentive to try it as the samples are free and it is not a controlled substance. Look for Wyeth to get a follow-on indication for Prestiq as it is also still on patent. Effexor will not as it is now off patent and there is no money incentive to get it pushed through the FDA.

As I said, I started Effexor when I was desperate for pain relief. I even tried drinking a quarter cup of vinegar first thing in the morning as it was suppose to help. It did get my eyes open in a hurry and cut down on GI gas but other than that did nothing for pain. I'm now stuck on a decrease of 10% every 4-6 weeks for the next one plus years. Otherwise I end up with dehabilitating withdrawals.

I know I'm probably biased but so are many others. Effexor Withdrawal- any suggestions? - Topix
| the Effexor Activist|

[trkdoc714]

I agree with you Jack. Being from Indianapolis, and having friends and family work for Lilly, their motivations hint a sense of urgency to get the approval. I'm also curious about the disenting votes being so high. 8 to 6 isn't a convincing margin. This wouldn't be the first time a spine patient was told they were/ are depressed. Does this mean the prescribing physician is treating the pain or the mental/ emotional anguish caused by spine problems?

The following is an article from the Indianapolis Business Journal.

Eli Lilly & Co. has won approval to sell the antidepressant Cymbalta, its second-biggest drug, as a treatment for pain.

The Food and Drug Administration cleared Cymbalta for musculoskeletal pain such as arthritis and chronic lower back conditions, the agency said Thursday in a prepared statement. An FDA advisory panel voted 8-6 in favor of Indianapolis-based Lilly’s application to expand Cymbalta use on Aug. 19.

Lilly is under pressure to maintain sales as its top drugs prepare for generic competition and new products struggle to reach the market. Broader approval of Cymbalta may provide only a small reprieve because the medicine’s patent expires in three years and it is already being prescribed as a painkiller, said Seamus Fernandez, an analyst at Leerink Swann & Co. in Boston.

“Half of that market opportunity could already be potentially accounted for,” Fernandez said in a telephone interview. He estimates annual sales of Cymbalta may increase by $500 million, or 16 percent, with approval for pain.

Sales of Cymbalta were $3.07 billion last year, accounting for 14 percent of Indianapolis-based Lilly’s revenue. The drug is scheduled to lose U.S. patent protection in 2013, along with the insulin Humalog, which ranks third in revenue. Top-selling Zyprexa, an antipsychotic, faces generic competition in 2011.

As Jack pointed out, the withdrawal is terrible. I took another Lilly drug, Elavil, for over a year after a head on collision. My family physician took me off of it abruptly as it was causing cardiac issues. The withdrawals were horrible and lengthy. On the other hand, I was able to stop taking Oxycontin with very little trouble after the ADR surgery.

Bob

[KBear]

I see both sides of this argument. I was on double the therapeutic dose of Cymbalta- was put on it for depression by family doctor, pain doctor doubled the dose for pain. It 'fixed' my depression so to speak and did decrease my pain, granted it was a part of several drug treatment. I was on Lyrica for nerve pain, Cymbalta, muscle relaxers, long acting morphine and Vicodin for short term relief. Now the withdrawals were a beast and I wouldn't wish that on anyone. I had completely gotten off of pain medication (all of my medications for pain) prior to quitting Cymbalta. I had pain all over my body, things I didn't know could hurt, hurt. I had tons of other withdrawals, one was like a weird shocking feeling where it felt like my entire body was being shocked at once, fuzziness in the head and so on. Morphine withdrawal had nothing on Cymbalta. It was awful hard, but at the same time, even knowing what I know now, I would still take it again for the benefits of it.

[Jack-of-all-trades]

KBear,

Your post reminded me of another potential disaster with using these drugs for pain. There are so many drug interactions that someone not well versed in using them for pain meds could kill someone. Most everyone knows the biggy about MAOs but few know about the risk of combining them with Lyrica and or Tramadol. They all have a net effect of increasing serotonin. Throw in some OTC DM cough medicine or St John's Wart and the likelihood of serotonin syndrome is high. Death could result.

[runagain]

Jack,

I agree with you. A psychologist friend of mine told me many people get on SRRIs and are on them for life. From what I have seen at my pain doctor's office, they offer you an SRRI to work in conjunction with the pain meds (potentiate) and don't tell you about the side effects or the fact that the drugs can have serious withdrawal symptoms.
I didn't even know this until people (you) started talking about it on here and then I looked the drugs up, doing some research and was quite surprised. They do have their place though, but the doctors should better inform the patients of what these drugs do chemically in their body.
IMHO, the pharmacy industry is really pushing the medications and that is not entirely a good thing.

R

[Cindylou]

I agree with you Jack, 100%.

Kathy, that is a helluva lot of pain medication your PM doc had you on for 1 level adr, imho. Why would your pain doc double the dose of Cymbalta for "pain" when you were already on long-acting Morphine, Vicodin for breakthrough and Lyrica, nerve pain medication, mind you, to boot? That just seems like a lot of pain medication, and it's not even including the muscle relaxants. Did you ever feel like you were being over-medicated? Just wondering... Glad you are done with meds, and feeling so good, honey, especially now that you are pregnant. Love the new avatar pic, btw. CL

[KBear]

CL- I was on a lot of medication, but always felt under medicated. My medication never took the all the pain away. It wasn't super high dose of Morphine, it was Kadian 20mcg twice a day and 4-5 10mg Vicodin a day. The Cymbalta was 60 mg twice a day, Lyrica 75 mg twice a day. I took the muscle relaxer, Zanaflex 3 mg, 1 or 2 at night for sleep. I honestly felt like they were not treating my pain very well, it was just enough to keep me from going off the deep end.... which I almost did because of the pain anyway.