Sharona Hoffman, professor of law and bioethics at Case Western Reserve University School of Law, says that step therapy is driven by a single motivator: saving costs. Hoffman, who’s written about the legal and ethical implications of step therapy, says that sometimes step therapy can have sensible outcomes, like pushing patients to take generics instead of brand-name drugs. But these policies can also keep doctors from prescribing the more expensive drugs of choice, forcing patients to take medications that are less effective or have worse side effects.
Postmarketing Experience: The following adverse reactions have been identified during postapproval use of LATISSE®: dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and vision blurred.
In the mid-1990s, people who received BOTOX for other conditions reported improvement in their chronic migraine pain. A two-phase study was conducted, treating patients who averaged 20 headache days a month. They received BOTOX injections every twelve weeks for 56 weeks. At the end of that period, 70% of the patients had fewer than half the number of headaches they had before treatment. The FDA officially approved BOTOX to treat chronic migraine in October of 2010. Since then, more than 100,000 patients have been treated.
Sunburn alert: The AHA/BHA Exfoliating Cleanser and AHA/BHA Cream in the Lytera® 2.0 Advanced Pigment Correcting System contain an alpha-hydroxy acid (AHA) that may increase the skin’s sensitivity to the sun and particularly the possibility of sunburn. Patients should use a sunscreen, wear protective clothing, and limit sun exposure while using these products (or this system) and for a week following.
It’s been a little over three weeks. The neurologist said that after two weeks, my migraines and headaches should be substantially reduced. I haven’t spoken about it much even to people close to me because I didn’t want to jinx it, but right around the two-week mark, my headaches faded. I did have a migraine the day after the injections, followed by a lingering headache for about a week, but my neurologist didn’t think it was caused by the Botox. I know my body and have a feeling it was, especially because the introduction or removal of medication can exacerbate lupus symptoms and flares, so I was put on a prednisone taper just to be safe.
Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, general ized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses. [See WARNINGS AND PRECAUTIONS]
Absolutely. Botox (and competitors like Dysport and Xeomin, which will be widely available next January) are highly purified toxins that can temporarily erase or reduce horizontal forehead lines, vertical frown lines, and crow's-feet. "The injections slow muscles that contract hundreds of times a day, eventually etching lines in the skin," says New York City plastic surgeon Michael Kane, author of The Botox Book (St. Martin's Press). Botox can also lift the corners of the mouth that sag with age, smooth out the "pin cushion" look in some chins, soften smoker's lines around the mouth, and soften vertical neck cords.
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Botox injections like other goods and services in New York City are typically more expensive then in the suburbs where the rent and salaries are also less expensive. So it is true that in general Botox cost more in NYC. In one vial of Botox there is 100 units of medicine and each unit costs on average $20. Most patients require between 20 to 60 units.That translates into an average between $400 and $1200.
"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."
There are no limits on therapy or activity after the session. For patients that don’t normally use a device to help them walk, at first it may seem like their walking has gotten worse. They need some time to get used to the feeling of the sudden change in the way their muscle contracts when they walk. This most often improves quickly over one to two weeks. Some very young children may have discomfort in their heel cord from rapid stretching. The child may limp or refuse to put weight on it. Again, this most often resolves quickly in the first week.
Preventative Botox has been getting lots of buzz. “It can potentially have a preventive effect on dynamic wrinkles, which are caused by underlying muscle movement,” Shah explains. “That being said, muscle movement is only one factor that contributes to the development of wrinkles, so Botox may not be completely preventive.” (Some other wrinkle causes: sun exposure, smoking, and diet.)
Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).