Understanding Fibromyalgia; How Experts are Diagnosing and Treating Their Patients - Episode 16
Experts discuss the long-term safety and efficacy of agents used for the treatment of fibromyalgia (FM).
Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP: What do we know about the long-term use of milnacipran, duloxetine, pregabalin in patients with fibromyalgia? Is there any evidence of tolerance, adverse events improvement? Anything long-term that we know.
Daniel Clauw, MD: All the drugs to get approved had to have one year open labeled extension. We have that much data, but not more than a year. And even though it was only 1,000 or 1,500 patients that got exposed for a year. After that, it's just like the regular surveillance system, which is not very good at telling us if there are long-term adverse effects for people taking these drugs for decades.
Benjamin Natelson, MD: For lack of efficacy. That's another issue. I seem to remember, although I couldn't cite it, there was a paper that was talking about these treatments and having a relatively short I guess as you pointed out, Dan, they have to have worked for a year, what's your experience, Wendy and you also Dr Botsoglou on long term adverse effects.
Kostas Botsoglou, MD: I've seen tolerance with some of these patients where they've been on it for quite a while and they just keep getting more breakthrough pain and so forth but in terms of safety, I haven't seen any new safety signals, we are doing chemistries and kidney functions and liver functions in these patients routinely anyway. It's more the tolerance that's the issue.
Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP: I agree with you, and we've seen that for years with SSRIs and tolerance. Part of me wonders is the condition worsening and that's why they're feeling or are they developing a tolerance? Certainly, with opioids we start to see Hy Opioid hyperalgesia and that's a real issue as well. But I don't know of any safety issues when these products are used long term.
Transcript edited for clarity.