Latest news with #BaumannCosmeticInstitute
Miami Herald
02-04-2025
- Health
- Miami Herald
FDA simplifies rules governing use of popular acne medication isotretinoin
The iPLEDGE program is a risk management system mandated by the U.S. Food and Drug Administration to prevent fetal exposure to isotretinoin, a medication used for severe acne that doesn't respond to other treatments. Accutane was a popular brand name for isotretinoin that is no longer available in the U.S. Other brands of prescription isotretinoin are still used, including Claravis, Absorica, Amnesteem and Zenatane. Due to isotretinoin's high risk of causing birth defects, strict protocols have been established to ensure that patients, especially those who can become pregnant, adhere to safety measures during treatment. However, some of the guidelines outlined in the iPLEDGE program were previously overly strict, confusing and non-inclusive. Finally, the FDA has modified the program's guidelines. Recent modifications to the iPLEDGE program In response to feedback from healthcare professionals and patients, the FDA has made significant changes to the iPLEDGE program to reduce administrative burdens and improve patient access: ▪ Elimination of the 19-day lockout period. Previously, if patients did not obtain their isotretinoin prescription within a seven-day window, they faced a 19-day waiting period before they could requalify for the medication. The recent changes have removed this lockout, allowing patients to resume treatment more promptly. ▪ Acceptance of at-home pregnancy tests. The FDA now permits the use of at-home and non-Clinical Laboratory Improvement Amendments (CLIA) pregnancy tests, reducing the need for in-office visits solely for testing purposes. ▪ Gender-neutral patient classifications. Recognizing the diverse patient population, the program has adopted gender-neutral categories, focusing on patients' reproductive potential rather than gender. Implications for acne patients These modifications should significantly improve the experience for patients taking isotretinoin by reducing treatment delays and thus leading to better treatment outcomes, reducing office visits for the sole purpose of testing and promoting inclusivity. Thus, if you are currently taking isotretinoin or are considering taking this medication, know that these guidelines should make the process much smoother and more streamlined moving forward. Bottom line The iPLEDGE program plays an important role in preventing harmful birth defects that could arise from use if isotretinoin. However, previous guidelines created several barriers for both patients and their doctors when treating and managing severe acne. These new guidelines are more reasonable, while still working to optimize patient safety. I'm still on sabbatical and no longer run Baumann Cosmetic Institute, so please follow @SkinTypeSolutions on social media, or visit if you have questions.
Miami Herald
27-02-2025
- Health
- Miami Herald
A diabetes drug may cut the risk of certain skin cancers, study finds
Metformin is a medication prescribed to help manage type 2 diabetes. Recent research suggests, however, this medication may potentially decrease risk of certain types of skin cancer. A retrospective case-control study published in the Journal of Drugs in Dermatology explored whether metformin could reduce the risk of non-melanoma skin cancers, specifically basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). What the research says Researchers analyzed data from the All of Us research database, which compiles health information from a diverse group of participants, to assess the potential impact of metformin on these two cancers. Metformin reduced the risk of basal cell carcinoma across all sex and ethnicity groups, the researchers found. For squamous cell carcinoma patients, though, the lines weren't as clear. In some cases, metformin users saw a significantly lower risk of squamous cell carcinoma, but that reduction was not significant in African American patients. The results suggest metformin may offer protective benefits against certain types of non-melanoma skin cancers, though its effectiveness may vary among different populations. It is important to note that metformin's effect on skin cancer is controversial and researchers do not yet understand how it might work to reduce the risk of certain skin cancers. Other studies have found that metformin may have an anti-inflammatory effect that lowers the risk of certain skin cancers, but we do not know this for certain. Side effects of metformin Metformin is generally considered safe and well-tolerated by most people, though side effects like nausea, vomiting and diarrhea may occur in up to 30% of people taking this medication. Less frequent side effects can include chest discomfort, weakness, headache, rhinitis, hypoglycemia and vitamin B12 deficiency (with long-term metformin use). A rare but serious side effect is lactic acidosis, with risk factors being older age, having a history of alcoholism and hepatic and/or renal impairment. Who might benefit? More research is needed to determine exactly how metformin may or may not help to reduce skin cancer risk. Based on the current evidence we do have, my advice is to discuss the use of metformin with your doctor if you have a history of multiple skin cancers and also a history of high blood sugar. I'm still on sabbatical and no longer run Baumann Cosmetic Institute, so please follow @SkinTypeSolutions on social media, or visit if you have questions.
