FDA approves Botox for migraine treatment
Federal health authorities have approved Botox injections for the treatment of chronic migraines in adults. The Food and Drug Administration recommended that Botox be injected approximately every three months around the head and neck to dull headache symptoms.
The drug is made by Allergan, Inc., of Irvine, California. The two company-funded studies submitted to the FDA involved 1,384 adults from 122 study sites in Europe and North America. They found that after six months, patients who got the drug experienced fewer days of migraine than they had before the studies started.
“The benefits are modest when you look at the overall results,” says Dr. Elizabeth W. Loder, associate professor of neurology at Harvard Medical School and the chief of the division of headaches in the Department of Neurology at the Brigham and Women’s Hospital in Boston.
“But, of course, within those results, there are always patients who do much better than the average and there are patients who don’t have any benefit,” she said.
The FDA stated the most common adverse reactions reported by patients being treated with Botox were neck pain and headache. Approximately one percent of patients on the drug found that their migraines worsened to the point they had to be hospitalized, but it was generally well-tolerated.
The drug labeling warns that the effects of the botulinum toxin may spread beyond where it is injected, causing symptoms that may include life-threatening difficulties swallowing and breathing.
The actual treatment requires doctors administer a total of 155 units to each migraine patient in 31 injections into muscles of the head and neck. The treatment is then repeated at three month intervals.
Allergan recently settled a Justice Department investigation into its marketing practices related to uses of Botox by paying $375 million and pleading guilty to a misdemeanor misbranding charge. The company also paid $225 million to resolve civil claims the Justice Department asserted under the civil False Claims Act.
So now that you’ve read the article, let me ask you a question.
How much sense does it make to you for someone to go to the doctor every three months and have 31 injections of the botulinum toxin into their muscles to temporarily freeze them for three months to feel better?
If the MD’s want to help by prescribing painkillers to dull pain, or inject Botox to reduce muscle pain… doesn’t it make more sense to find the actual cause of the muscle pain and spasm and relax the muscles permanently by correcting the imbalance between the maxillae and mandible that caused the muscle pain in the first place?
That’s what we do here at the Atlanta Center for TMJ.