22 Matching Annotations
  1. Aug 2019
  2. Aug 2018
    1. GLP-1 receptor agonists

      Semaglutide now included among GLP-1 receptor agonists

      In December 2017, the U.S. FDA approved the GLP-1 receptor agonist semaglutide as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

      Reference:

      U.S. Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209637. Accessed January 1, 2018

      Rationale: Approval of new treatments (medications or devices) has the potential to impact patient care.

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from [link to annotation].

    2. SGLT2 inhibitors

      Ertugliflozin now included among SGLT2 inhibitors

      In December 2017, the U.S. Food and Drug Administration approved the SGLT2 inhibitor ertugliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

      Reference:

      U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Available from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209803. Accessed 1 January 2018

      Rationale/Reason for Change: Approval of new treatments (medications or devices) has the potential to impact patient care.

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from https://hyp.is/1LVY-jwpEeiYsffMyzm1HQ/care.diabetesjournals.org/content/41/Supplement_1/S73.

    3. Table 8.2

      Table 8.2 to include semaglutide

      In December 2017, the U.S. FDA approved the GLP-1 receptor agonist semaglutide as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

      Reference:

      U.S. Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209637. Accessed January 1, 2018

      Rationale/Reason for Change: Approval of new treatments (medications or devices) has the potential to impact patient care.

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from https://hyp.is/D0tVED2WEeiK8ZvLIDyLZg/care.diabetesjournals.org/content/41/Supplement_1/S73.

    4. Table 8.2

      Table 8.2 to include ertugliflozin

      In December 2017, the U.S. Food and Drug Administration approved the SGLT2 inhibitor ertugliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

      Reference:

      U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Available from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209803. Accessed 1 January 2018

      Rationale/Reason for Change: Approval of new treatments (medications or devices) has the potential to impact patient care.

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from https://hyp.is/8Qjypj2VEei_E2-Ft0MSjQ/care.diabetesjournals.org/content/41/Supplement_1/S73.

  3. Nov 2017
  4. Feb 2017
    1. To further clarify the homeopathic dosages of Belladonna in Baby Teething Tablets, a 10-pound child would have to accidentally ingest, all at the same time, more than a dozen bottles of 135 Baby Teething Tablets before experiencing even dry mouth from the product.

      This is true if the product was manufactured to a consistent standard. It was found that this was not the case.

    2. Hyland’s Baby Teething Tablets have been safely used by millions of children since being introduced to the U.S. market in 1945!

      A history of good manufacturing processes does not speak to the current quality of that process. The fact is that it has been found that this process is no longer as good as it used to be.

    3. We care about your child, and our consumers’ safety is our #1 priority.

      As of 27 January 2017, and despite a request from the FDA, Hylands have refused to recall the product: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm

    4. To further clarify the homeopathic dosages of Belladonna in Baby Teething Tablets, a 10-pound child would have to accidentally ingest, all at the same time, more than a dozen bottles of 135 Baby Teething Tablets before experiencing even dry mouth from the product.

      This is an unreferenced claim, but it assumes that the quantity of Belladonna alkaloids are as stated on the label.

      In their laboratory analysis of 474 tablets of this product, the FDA detected the Scopolamine alkaloid in 174 of them (36.7%). The quantity in 45 of these 174 was 'Below Limit of Quantification', but the others (n=129) had quantities from 0.1 μg to 53.4 μg, a variation of 534 to 1.

      https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm230762.htm

    5. Belladonna is included in the Tablets to ease the redness, inflammation and discomfort of the child’s gum that often occurs during the teething process.

      While this item is included the manufacturing process of Homeopathy should remove any useful amount of it from the end product. Hyland’s Teething Tablets offer no relief from the redness, inflammation and discomfort from this ingredient.

      Also; this: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm230762.htm

  5. Sep 2016
  6. Feb 2015
    1. The FDA has also established an acceptable daily intake (ADI) for each artificial sweetener. This is the maximum amount considered safe to consume each day over the course of your lifetime. ADIs are intended to be about 100 times less than the smallest amount that might cause health concerns.

      How is Acceptable Daily Intake calculated by FDA

    2. Artificial sweeteners are regulated by the Food and Drug Administration (FDA) as food additives.