Now, thanks in large part to off-label use, Botox--the wrinkle smoother that exploded as a cultural phenomenon and medical triumph--is increasingly being drafted for problems that go far beyond the cosmetic. The depression suffered by Rosenthal's patient is just one example on a list that includes everything from excessive sweating and neck spasms to leaky bladders, premature ejaculation, migraines, cold hands and even the dangerous cardiac condition of atrial fibrillation after heart surgery, among others. The range of conditions for which doctors are now using Botox is dizzying, reflecting the drug's unique characteristics as much as the drug industry's unique strategies for creating a blockbuster.
BOTOX for migraines is an innovative, FDA-approved procedure. BOTOX is a unique approach to migraine relief that is proving to be highly effective for many patients living with the condition. Rather than reducing the symptoms of an existing headache, BOTOX works to prevent future headaches, and helps avoid the continued use of powerful prescription pain medications.
Our advice: if you’re going to try it, don’t give up on Botox for Migraine after the first try, and reconsider whether you’re a good candidate after three tries. Both Drs. Jackson and Kornel noted that there was a large placebo effect seen in many of the studies. “It’s hard to know if most of the benefit was from the drug or from the placebo effect,” said Jackson, who added, “but, patients don’t care if it’s a placebo effect.”
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
In her talk, Lalvani expressed her intent to drive AMF’s mission forward by leveraging the expertise of the American Headache Society and incorporating more patient voices. The Move Against Migraine support community is essential to that goal, and AMF strives to be a trusted partner for support, resources and credible information for everyone in the community. The Move Against Migraine campaign was launched to raise awareness of migraine, but that’s only the beginning. Lalvani pointed to AMF’s advocacy and community-building efforts, specifically the response to Elle’s “Migraine Pose” article and robust partnership program. Whatever the platform and audience, AMF works to ensure the patient voice is always included and heard. Lalvani concluded her talk by stressing that patients have an important role to play as “drivers of change” and encouraged listeners to continue connecting with AMF. Check out our full library of Facebook Live recaps with some of the leading headache specialists and patient advocates in the country, and visit our resource library for more information on how you can better advocate for yourself and the migraine community.
Botox prevents migraine headaches before they start, but takes time to work. “I look to the second and third treatments to maximize effects,” says Dr. Andrew Blumenfeld. “Patients see increasing benefit with an increase in the number of treatment cycles.” One treatment lasts for 10-12 weeks, and patients reported that two Botox treatments reduced the number of headache days by approximately 50%.
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions a ssociated with the unapproved uses of BOTOX. The safety and effectiveness of BOTOX for unapproved uses have not been established.
I increase the dose at each treatment cycle to 195 units. This is based on experience with patients with cervical dystonia, in whom higher doses result in a longer duration of effect. In addition, I transition to the next onabotulinumtoxinA treatment at 12 weeks by using occipital and trigeminal nerve blocks at 10 weeks. Most insurance companies will not cover onabotulinumtoxinA treatments earlier than 12 weeks, but in rare cases, 10-week cycles have been approved.
In double-blind, placebo-controlled chronic migraine efficacy trials (Study 1 and Study 2), the discontinuation rate was 12% in the BOTOX treated group and 10% in the placebo-treated group. Discontinuations due to an adverse event were 4% in the BOTOX group and 1% in the placebo group. The most frequent adverse events leading to discontinuation in the BOTOX group were neck pain, headache, worsening migraine, muscular weakness and eyelid ptosis.
Recently, there has been an emerging trend of “BOTOX® Cosmetic parties,” in which several people gather at a physician’s house or another location to have BOTOX® Cosmetic injections at a lower cost. While prices for treatment may be somewhat lower at a BOTOX® Cosmetic party than for treatment administered during a normal office visit, the situation may not be ideal. The American Academy of Dermatology and the American Society of Aesthetic Plastic Surgery have both issued warnings against such “parties,” as they have reservations about the ability of the physician to provide a safe and sterile environment outside of their office.
The FDA approved such usage in the late 1980s upon the discovery that Botox could stop ailments like blepharospasm (uncontrolled blinking) and strabismus (lazy eye). Doctors have been using Botox for years to successfully treat wrinkles and facial creases. In April 2002, Botox gained FDA approval for treatment of moderate-to-severe frown lines between the eyebrows - called glabellar lines. However, Botox is often used for other areas of the face as well.
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"I have treated people with profound migraine headaches and it turns them right off," says Dr. Matarasso. "If you feel it coming on, it stops it, reducing the severity as well as the duration. I had a patient [who was] in college who had unremitting migraine headaches. She changed her diet, she changed her birth-control pill, she had acupuncture. I finally said to the mother, 'We need to try Botox,' and it has been a complete life-changing event for this woman."
In some cases known as off-label use, doctors are safely administering it for conditions other than what it is officially approved for, including prostate issues, and eye-crossing (known medically as strabismus) cerebral palsy—which had my jaw on the floor. Rowe even went on to tell me it's the drug of the twenty-first century. "It's like Tylenol or aspirin," he marveled to SELF. "It's what penicillin was in the mid-twentieth century."