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].

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.

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.

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.

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

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.

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

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

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

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How is Acceptable Daily Intake calculated by FDA