Strabismus

While AbbVie's Botox dominates the medical aesthetics field, some new rivals have emerged. Public Citizen wants the FDA to change its messaging around the products. The U.S. advocacy group Public Citizen is taking aim at AbbVie’s medical and cosmetic injection Botox, as well as its new rivals, over safety and promotional issues with the shots. In a petition sent to the FDA, Public Citizen asked the FDA to “remove misleading promotional statements from the labeling of Botox and Botox Cosmetic” and to "strengthen the black box warning in the labeling of all approved Botox and related drugs.” Botox is the market leader in the medical aesthetics field, having been around for 34 years and generating around $5 billion annually for AbbVie. The Illinois-based pharma giant picked up the blockbuster drug from its buyout of Allergan in 2019. While Botox dominates the field, Public Citizen also wants the same crackdown for the med's rivals. Those are Revance Therapeutics' Daxxify, Evolus' Jeuveau, Supernus Pharmaceuticals' Myobloc, Galderma's Dysport, and Merz Therapeutics’ Xeomin. All of these products contain a form of a highly potent neurotoxin that can be used to treat cosmetic conditions, such as smoothing out wrinkle lines or, as is the case with Botox, also have medical labels, such as for migraines and incontinence. But there can be serious safety risks when using these neurotoxins, and Public Citizen wants the FDA to shore up messaging around the products. The group has a long history with Botox and originally petitioned for the drug’s black-box warning back in 2008. It argues that the current warning, which was slapped on the drug by the FDA in 2009, still does not go far enough as it “fails to explicitly mention the risk of ‘systemic iatrogenic botulism.'" This is a potential complication of Botox treatment and related drugs that can cause muscle paralysis or weakness, the group said. The advocacy group also wants the removal of “misleading promotional statements” from the labeling of Botox and Botox Cosmetic. These promotional statements are also related to potential safety risks, with Public Citizen singling out the claim that “[n]o definitive serious adverse event reports of distant spread of toxin effect” were associated with the use of recommended doses of these drugs to treat four therapeutic indications (blepharospasm, chronic migraine, severe underarm sweating, and strabismus) and certain approved cosmetic uses. It points out that regulators in other countries, including Canada and the U.K., do not use this claim, and that, when combing through the FDA’s safety database, the group said it saw that “Botox was the primary suspect when used to treat one of the four therapeutic indications listed in the misleading claims,” and that “269 (42%) included adverse reactions that were suggestive of iatrogenic botulism.”

Physician shares key differences between strabismus and amblyopia RAHWAY, N.J., Nov. 2, 2023 /PRNewswire/ -- As children grow and develop, some parents may notice that their eyes begin to point in different directions and become misaligned. This condition is known as strabismus, and it's relatively common. About 3% of children have strabismus. In a new editorial from MerckManuals.com, Leila M. Khazaeni, MD, Loma Linda University School of Medicine, shares what parents need to know about strabismus and some key differences between the condition and amblyopia. 1. There are several types of strabismus Strabismus is the medical term for misalignment of the eyes. There are many different types, and most people know the condition by its more informal names like crossed-eyed or wandering eye. Some types are characterized by inward turning of the eye (esotropia or cross-eye) and some by outward turning of the eye (exotropia or walleye). Other types are characterized by upward turning of the eye (hypertropia) or downward turning of the eye (hypotropia). 2. Strabismus can lead to amblyopia, known as lazy eye There's often confusion between strabismus and amblyopia. All types of strabismus can lead to amblyopia, also known as lazy eye. Amblyopia is a decrease in vision that occurs because the brain ignores the image received from an eye and can be caused by misalignment of the eye. If left untreated, about 50% of children with strabismus have some vision loss due to amblyopia. 3. Strabismus does not go away on its own If a child is showing signs of misalignment in their eyes, parents may want to wait and see if the condition goes away on its own. The reality is, people do not grow out of strabismus. It will continue to impact an individual's vision until it's treated. Anyone displaying signs of strabismus should be seen by a doctor promptly to determine the right treatment plan and avoid potential vision loss. 4. Strabismus is most often treated with surgery In most cases, treatment entails outpatient surgery to either weaken or strengthen the eye muscles to align the eyes. In some cases, full-time glasses are recommended. Depending on the severity and progression of the condition, doctors may first work to equalize vision and correct amblyopia that has occurred. This can be achieved through eye patches or drops that strengthen the vision in the weaker eye. These are only treatments for amblyopia (decrease in vision), not strabismus (misalignment). 5. Every child should have regular vision screenings Children should be examined periodically to measure vision and to detect strabismus starting at a few months of age. Traditional screening methods or photo screenings are both effective. You can read more about osteoporosis in Dr. Khazaeni editorial on MerckManuals.com. About The Merck Manuals and MSD Manuals First published in 1899 as a small reference book for physicians and pharmacists, The Merck Manual grew in size and scope to become one of the world's most widely used comprehensive medical resources for professionals and consumers. As The Manual evolved, it continually expanded the reach and depth of its offerings to reflect the mission of providing the best medical information to a wide cross-section of users, including medical professionals and students, veterinarians and veterinary students, and consumers. In 2015, The Manuals kicked off Global Medical Knowledge 2020, a global initiative with the goal to make the best current medical information accessible by up to three billion professionals and patients around the world by 2020. The Manuals achieved that goal, and today its medical information is available in more than 241 countries and in 13 languages. 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New research from eye care nonprofit Orbis International analyzes the overall wellbeing of children with common childhood vision problems NEW YORK, Sept. 13, 2023 /PRNewswire/ -- A new study by eye care nonprofit Orbis International found that children with myopia (nearsightedness) and strabismus (misalignment of the eyes) experienced significantly reduced quality of life compared to those without vision impairment. Published in the peer-reviewed journal Ophthalmology, the study also finds that surgical treatment of strabismus improves quality of life among children, underscoring the importance of early detection, treatment, and health insurance coverage of strabismus for children. Made possible with financial support from vision company Santen, the study is the first systematic review and meta-analysis of the links between quality of life in children and vision impairment, ocular morbidities, and their treatment. A child smiles when trying on eyeglasses for the first time at an Orbis Green Vision Center in Satara, Maharashtra, India.