Q: The Federal Drug Administration just denied approval for a new treatment of fibromyalgia. Now what am I going to do? Nothing helps my fibromyalgia!
A: The medication you are referring to, sodium oxybate, was previously approved under the name Xyrem for the treatment of excessive daytime sleepiness, and approval was sought by Jazz Pharmaceuticals under the name JZP-6 for the treatment of fibromyalgia. The FDA declined to approve fibromyalgia as a indication for the medication because of concerns about its safety. Xyrem is the sodium salt of the chemical gamma-hydroxybutyrate, or GHB, which has been misused as a club drug or for date rape. You can understand why the FDA is concerned about stashes of sodium oxybate freely available medicine cabinets around the nation. What if your teenager got ahold of it and gave it out to his friends?
While the reasons for the FDA's concern are obvious, the risks of having a medication such as sodium oxybate in the medicine cabinet are surely no greater than the risk of having vodka in the liquor cabinet; the vast majority of drug-facilitated sexual assaults are in fact facilitated by alcohol. And, like alcohol, sodium oxybate has sedative-hypnotic effects on the body. Both can cause dependence. Don't fall into the trap of self-medicating with alcohol. This can be a very destructive path.
Patients with fibromyalgia have a syndrome of widespread pain, usually in certain muscle groups, and usually worsened with pressure. People who have fibromyalgia frequently have depression, anxiety, and sleep disorders as well. The cause of fibromyalgia is not well understood, but appears to be more likely among people who are under stress, or who have had psychological or physical trauma. So what to do? Here's the thing: you physician is permitted to prescribe medications off-label, meaning that he can prescribe Xyrem for yourfibromyalgia if he thinks that it is in the best interest of your health. The FDA's denial means that the pharmaceutical company cannot market the medication for the treatment of fibromyalgia.But let's say that you agree with the FDA; you do not want to take a medication that works similarly to alcohol, and you do not want the medication sitting around in your cabinet for someone to swipe. What else can you do to combat fibromyalgia?1) Partner with your doctor. Sometimes what patients think is fibromyalgia is actually Lyme disease, vitamin D deficiency, magnesium deficiency, or something else. A good history and physical with lab testing may point you in a different direction. A good doctor will helpyou explore all reasonable treatment possibilities including medications (and will talk you out of those that are not worth the risk).
2) Get more and better quality sleep. Good quality sleep is important for the healing of all body tissues. Plan your sleep for when it is dark out, take a warm shower and drink a glass of warm milk before bed. If you are not diabetic, stir in a teaspoonful of honey into that warm milk. Turn off the phone, the computer and the television at least an hour before you want to sleep. Use dark curtains in your bedroom. If these simple measures do not work for you, ask your doctor about taking a melatonin supplement or a sleep aid such as diphenhydramine. Stronger sleep aids can be habit forming.3) Do moderate exercise. Tai Chi is supposed to help.4) Talk to your doctor about referring you for cognitive-behavioral therapy for fibromyalgia. These type of treatments can be quite effective.5) Increase your intake of fruits and vegetables. The vitamins, minerals, and antioxidants in fruits and vegetables may help with symptoms offibromyalgia.See what others have to say about this story or leave a comment of your own.Dr. Barbara Lock is a practicing emergency physician and a co-founder of MedPie.com.
