Saturday, December 20, 2014
Time for Congress to take up compensation for victims
Time for Congress to take up compensation for victims
Back in 1997, Congress took oversight of compoundingpharmacies away from the federal Food and Drug ...
Livingston Daily - 14 mins ago
2015 Drug Formulary - HealthPlus of Michigan-Covered compounded medications and injectable medications
2015 Drug Formulary - HealthPlus of Michigan
https://www.healthplus.org/.../Drug.../HealthPlus_2015_VenturePlus_Signat...
Women's Health Research Institutes: Compounded Bioidentical Hormone Therapy under scrutiny
Unsubstantiated claims, lack of scientific safety and efficacy data, and lack of quality control continue to surround custom-compounded bioidentical hormone products and yet, many women seem to believe that they are somehow “safer” than lab synthesized hormones. FDA-approved hormone therapy provides tested and regulated therapy without the risks of unregulated and untested custom preparations that often include custom compounded therapies.
Bioidentical hormones, a marketing term not recognized by the US Food and Drug Administration (FDA), refers to exogenous hormones biochemically similar to those produced within the body and includes 17A-estradiol (predominant estrogen before menopause), estrone (predominant estrogen after menopause), estriol (from placenta), progesterone (ovaries, placenta, and adrenal glands), testosterone (ovaries and adrenal glands), and their conjugates.[1] These are derived from soy and yam precursors and must be chemically processed to make them able to be absorbed by the human body.
Hormones that meet the definition of bioidentical are available as FDA-approved prescription therapies and include estradiol (oral, patch, gel, lotion, mist, and vaginal ring, cream, or tablet) and micronized progesterone (oral or vaginal). The FDA has not approved estriol. Custom-compounded bioidentical hormone products are prepared, assembled, and packaged according to a provider’s prescription into gels, creams, lotions, sublingual tablets, subdermal implants, suppositories, or troches.[2] Transdermal therapies avoid the first-pass effect through the liver, and there is evidence that they have a lower clotting risk.[3] Progesterone may have fewer negative effects than syntheticprogestins on lipids, sleep and mood, and breast (density, tenderness, and cancer risk) when combined with estrogen. No FDA-approved testosterone therapy (bioidentical or otherwise) is available for women.
Lack of Testing for Efficacy, Safety, and Quality Control
The major difference between FDA-approved hormone products meeting the definition of bioidentical versus custom-compounded products is that the former are regulated by FDA, tested for purity, potency, and efficacy, and sold with FDA-approved product information that includes boxed warnings. Efficacy and safety data, required for obtaining particular product indications, have been demonstrated in randomized, clinical trials with peer-reviewed published reports for FDA-approved bioidenticals but not for custom-compounded products.[4,5]
No large, long-term studies have been done to determine the effectiveness, safety, or adverse effects of custom-compounded bioidentical hormones. In 2008, because of lack of scientific data on estriol, FDA stated that pharmacies should not compound drugs containing estriol unless the prescriber has a valid investigational new drug application.[4]
To read the entire article, visit Menopause. To learn more about your options during menopause visit MenopauseNU.org developed by the Women’s Health Research Institute at Northwestern University.
- See more at: http://blog.womenshealth.northwestern.edu/2014/12/compounded-bioidentical-hormone-therapy-under-scrutiny/#sthash.VXa6p5gg.dpufPatient-Focused Drug Development Tracker By Alexander Gaffney, RAC - Published 19 December 2014
Patient-Focused Drug Development Tracker
The US Food and Drug Administration's patient-focused drug development program is poised to overhaul how drugs are approved for rare and inadequately served diseases and conditions. This tracker provides an in-depth look at what questions FDA is asking of patients and their representatives.
- See more at: http://www.raps.org/focus-online/news.aspx#sthash.RAzvnbVq.dpufRegulatory Affairs Professionals Society has a great FDA Legislation Tracker
FDA Legislation Tracker
Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often.
- See more at: http://www.raps.org/focus-online/news.aspx#sthash.RAzvnbVq.dpufEssential Ready!! Maryland Poison Center: A Case Involving a 48 year old woman who intentionally ingested a compounded pain cream made for her; harm caused to babies and others from compounded pain creams
Compounded Pain Creams and Ointments Highlighted in ... 
mdpoison.com/.../December%202014%20ToxTi...
Maryland Poison Center
Subscribe to:
Posts (Atom)