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• Environmental effects on skin aging, potential adverse events of onabotulinumtoxinA
Our newest slides explore the effects of environmental factors, including skin cancer history and smoking, on skin aging. We also explore a study of the safety and tolerability of onabotulinumtoxinA for facial lines.
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• FDA Gives Update on Botulinum Toxin Safety Warnings; Established Names of Drugs Changed
The FDA announced an update to a previous safety alert on four botulinum toxin drug products, noting that all of them now have boxed warnings on their labels and have developed Medication Guides for patients, as directed by the agency in April 2009. More here.
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• FDA Requires Boxed Warning for Botulinum Toxin Products
The FDA has notified the manufacturers of licensed botulinum toxin products of the need to strengthen warnings in labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected. The FDA also urges manufacturers to develop and implement a Risk Evaluation and Mitigation Strategy (REMS) to ensure that product benefits outweigh risk.
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• FDA Warning Letter Sent for Bimatoprost Ophthalmic Solution (Latisse™)
The FDA issued a warning letter to Allergan, Inc., manufacture of the eyelash enhancer, bimatoprost ophthalmic solution (Latisse™), for minimizing risks associated with the product's use. More here.
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