With regard to detection, current protocols using NBC detection equipment (such as M-8 paper or the ICAM) will not indicate a "positive" when samples containing botulinum toxin are tested. To confirm a diagnosis of botulinum toxin poisoning, therapeutically or to provide evidence in death investigations, botulinum toxin may be quantitated by immunoassay of human biological fluids; serum levels of 12–24 mouse LD50 units per milliliter have been detected in poisoned patients.
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."
There have been spontaneous reports of death, sometimes associated with dysphagia, pneumonia, and/or other significant debility or anaphylaxis, after treatment with botulinum toxin. There have also been reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease. The exact relationship of these events to the botulinum toxin injection has not been established.
Table 14 presents the most frequently reported adverse reactions in a placebo-controlled, double-blind post-approval 52 week study with BOTOX 100 Units (Study NDO-3) conducted in MS patients with urinary incontinence due to detrusor overactivity associated with a neurologic condition. These patients were not adequately managed with at least one anticholinergic agent and not catheterized at baseline. The table below presents the most frequently reported adverse reactions within 12 weeks of injection.
The median duration of response in Study OAB-1 and OAB-2, based on patient qualification for re-treatment, was 19-24 weeks for the BOTOX 100 Unit dose group compared to 13 weeks for placebo. To qualify for re -treatment, at least 12 weeks must have passed since the prior treatment, post-void residual urine volume must have been less than 200 mL and patients must have reported at least 2 urinary incontinence episodes over 3 days.
“We don’t believe Botox is expensive when you look at the value that we provide,” says Marc Forth, senior vice president of US marketing at Allergan, the maker of Botox. Botox halves migraine days in 50 percent of patients who get the injections, Forth says. “We believe that value is worth the tradeoff.” Allergan doesn’t have a say on step therapy policies. Insurers “ultimately make that call on their own,” Forth says.
"In the majority of these cases, it's the doctors at the front line who start using Botox off-label, and then we see the treatment of things we never expected the toxin to work for," says Min Dong, a researcher at Harvard Medical School who studies botulinum toxins in the lab and has no financial ties to Allergan. "I meet with physicians who are using the toxin everywhere--for diseases you would never know about."
When moving a spastic limb through its range of motion, one feels a resistance to movement that increases with the speed at which one moves the limb. This is the definition of spasticity, but other terms such as increased muscle tone, hypertonicity, spastic dystonia, or flexor / extensor spasms are used to describe this resistance. In clinic the term "muscle spasticity" will be used to reduce confusion of terms.
García Leiva specified that this treatment "is not a first-choice treatment for migraine sufferers, but it can only be applied in patients with chronic migraine who have tried several treatments with poor results, and who show peripheral sensitization of muscles. Recently, the Foods and Drugs Administration (USA) has approved botulinum toxin as a therapeutical drug for the treatment of chronic migraine.