Diabetes Monitor - Diabetes Monitor - Instructions And Labels

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Publication Date: 1/6/2010

Prescription medications such as diabetes pills and insulin products are regulated by governmental bodies to assure quality and appropriate use. In the US, the FDA regulates medications, and requires "labels" to be approved. "Package inserts" are written for health care providers. They contain very detailed information about different drugs. Frequently, there are also official documents for patients, called Patient Information leaflets. The manufacturers prepare this information, and the FDA approves it (sometimes after considerable discussions and negotiations!).

In Europe, a similar process is used, with the "label" called the Summary of Product Characteristics (SPC, or SmPC). The patient-oriented document is called a "Package Leaflet" or "Patient Information Leaflet". (See below for SPC/PILs from the UK and other countries.)

Copies of the current labels are usually available at the products' websites, but sometimes are hard to locate, as there is no standard method for companies to display this information. Look for "health professional" sections, and for statements such as "for more information" or "additional important information" or "Rx information". Sometimes these documents are in pop-ups, so if you have a pop-up blocker, you may have to disable the blocker; sometimes these documents are in PDF format and require Adobe Acrobat to read.

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Drugs@FDA

The FDA has a section at their website called Drugs@FDA, which is a database that includes current and prior labeling information about FDA-approved drug products. You can search by Drug Name, Active Ingredient, or Application Number, or look at drug approvals by month.

You can read and print copies of the FDA-approved package inserts for most diabetes drugs; direct links to some examples are provided below. These documents are in PDF format and require Adobe Acrobat to read.

Actos (pioglitazone) Label (12/11/2008 version)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s034lbl.pdf

Avandia (rosiglitazone) Label (10/20/08 version)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s034lbl.pdf
Byetta (exenatide) Label (1/11/08 version)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s012lbl.pdf
Glucophage XR (glipizide) Label (8/27/08 version)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf
Lantus (glargine) Label (4/25/07 version)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021081s024lbl.pdf
Starlix (nateglinide) Label (7/15/2008 version)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021204s011lbl.pdf

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FDA Medication Guides

The FDA also has consumer information for some drugs, located at a section of the FDA website called "Medication Guides." The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. Here are the ones relating to diabetes drugs, as of 17Aug2009:

Actoplus Met XR (pioglitazone/metformin) Medication Guide
2009 version
Avandia (rosiglitazone) Medication Guide
2008 version
Avandamet (rosiglitazone/metformin) Medication Guide
2008 version
Avandaryl (rosiglitazone/glimepiride) Medication Guide
2008 version
Exubera (inhaled insulin) Medication Guide
2008 version (note: Exubera is no longer marketed.)

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Electronic Medicines Compendium

The electronic Medicines Compendium (eMC) contains information about UK licensed medicines, and includes SPCs (for physicians) and PILs (for patients). electronic Medicines Compendium is located at the Medicines.org.uk website (http://emc.medicines.org.uk/) Some examples of diabetes medications include:

Amaryl (glimepiride) SPC
http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=814
Amaryl (glimepiride) PIL
http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=3067
Lantus (insulin glargine) SPC
http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=8962
Lantus (insulin glargine) PIL
http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=8903

Other on-line labels and patient information

SPCs for medications approved in Japan may be found (in English) at the The Japan Pharmaceutical Manufacturers Association website (http://www.e-search.ne.jp/~jpr/jpr_db/eindex.html)

Data Sheets for medications approved in New Zealand may be found at the New Zealand Medicines and Medical Devices Safety Authority (http://www.medsafe.govt.nz/)

Electronic Package Inserts for medications approved in South Africa may be found at South African Electronic Package Inserts (http://home.intekom.com/pharm/)

Also see

Diabetes Pills
Insulin
Medications for People with Diabetes