BioTE Medical Review

My wife suffered heart condition due to Biote Hormone Pellet Therapy. Some research on the web to warn and help other people: www.pharmwatch.org/strategy/bioidentical.shtml Steer Clear of “Bioidentical” Hormone Therapy / by Stephen Barrett, M.D. “The bottom line for consumers is very simple: Steer clear of anyone who prescribes “bioidentical” hormones.” Recent developments in the medical field have provided documentation of serious conditions that are related to testosterone therapy. | Even the FDA has issued warnings about the risks involved for those who choose to pursue testosterone therapy in an effort to improve low testosterone levels. Medical study points to increased risk of serious heart conditions. In November of 2013 the Journal of the American Medical Association (JAMA) published the results of a study that indicated testosterone therapy causes an increase in a person’s risk of heart attack, stroke, and death. | There were 9,000 males with a mean age of 60 who participated in the study. All of the men who participated in the study had survived coronary angiography and had been diagnosed with low testosterone levels. Of the fifteen percent who underwent testosterone therapy, twenty six percent had a heart attack, stroke, or died from another reason within the three year test period. Researchers compared the totals to those in the study who did not take testosterone medications and came to the conclusion that the therapy increased the risk of serious heart conditions by thirty percent. | On October 31, 2005, the American College of Obstetricians and Gynecologists (ACOG) warned against these products and the saliva tests typically used by those who prescribe them. In strongly worded documents [4,5], ACOG stated: There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies. Most compounded products have not undergone rigorous clinical testing for either safety or efficacy. There are also concerns regarding their purity, potency, and quality. | The FDA requires manufacturers of FDA-approved products that contain estrogen and progestins to include a black box warning that reflects the findings of the Women’s Health Initiative. However, compounded products (including “bioidentical” hormones) are not approved by the FDA and have been exempt from having to provide patient package inserts that contain warnings and contraindications for estrogens and progestins.” | www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm561444.htm FDA WARNING LETTER Dr. Gary S. Donovitz, Principal-Owner & Chairman BioTE Medical, LLC 1875 W. Walnut Hill Lane, Suite 100 Irving, Texas 75038 Dear Dr. Donovitz: From October 24, 2016 through November 4, 2016, the U.S. Food and Drug Administration (FDA) inspected your warehouse and distribution center located at 1875 Walnut Hill Lane, Suite 100, Irving, Texas where your dietary supplement products are received, stored, and distributed under the name, BioTE Medical. The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). | These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C § 342(g)(1)] in that they have been prepared, packed, or held under insanitary conditions that do not meet CGMP regulation for dietary supplements. The inspectional observations were provided to Mr. Mark Hincher, President, on the Form FDA 483 Inspectional Observations issued, at the conclusion of our inspection. Unapproved New Drug Violations Examples of some of the claims on your product labeling that provide evidence that your products are intended for use as drugs include: BioTE DIM Within your “All about DIM” marketing brochure: “Therefore, DIM can help to further reduce the risk of atherosclerosis…help guard against prostate enlargement, a condition known as benign prostatic hypertrophy” “[E]ndometriosis…cervical dysplasia, have been observed to improve with DIM supplementation.” | Within your “AGE HEALTHIER AND LIVE HAPPIER bioTE Bio-Identical Hormone Balance for Men and Women” marketing brochure: Adequate Iodine supplementation can control and reduce: ●ADD/ADHD ●Atherosclerosis ●Breast Diseases…●Fibrocystic Breast ●Goiter ●Ovarian Disease ●Parotid Duct Stone ●Peyronie’s ●Prostate Disorders…●Thyroid Disorders ●Vaginal Infections ●Hemorrhoids ●Headache/Migraines ●Hypertension ●Infections …●Liver Diseases” www.beaumontenterprise.com/news/article/Board-alleges-Nederland-nurse-put-patients-at-12308178.php “Morgan filed suit against BioTE Medical, LLC in March, claiming that the company, which trains practitioners in its pellet-based hormone therapy method, is holding him to a non-compete provision in a contract that he believes is not valid. | Formal charges filed last week by the Texas Board of Nursing against the owner of a Nederland clinic raided by federal agents Tuesday allege that his prescriptions for testosterone and thyroid hormone put 12 patients at risk and may have contributed to two deaths.” www.jrlawfirm.com/library/dallas-testosterone-therapy-lawyer/ Dallas BioTE Therapy Laywer “Recent developments in the medical field have provided documentation of serious conditions that are related to testosterone therapy. Even the FDA has issued warnings about the risks involved for those who choose to pursue testosterone therapy in an effort to improve low testosterone levels.”

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Name: BioTE Medical

Country: United States

State: Alabama

City:

Address:

Phone: (877) 992–4683

Website: www.biotemedical.com

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