rescription 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.
[Top]
Some FDA-Approved Package Inserts and Patient Information for Diabetes Medications
You can read and print copies of the FDA-approved package inserts for the drugs listed below. These documents are usually in PDF format and require Adobe Acrobat to read.
Actos (pioglitazone) Label
http://www.fda.gov/cder/foi/label/1999/21073lbl.pdf
Avandia (rosiglitazone) Label
http://www.fda.gov/cder/foi/label/1999/21071lbl.pdf
Glucophage XR (glipizide) Label
http://www.fda.gov/cder/foi/label/2000/21202lbl.pdf
Glucotrol XL (glipizide) Patient Information
http://www.glucotrolxl.com/pi.asp (at the product's website).
Glucovance Label
http://www.fda.gov/cder/foi/label/2000/21178lbl.pdf
Prandin (repaglinide) Label
http://www.fda.gov/cder/foi/label/2002/20741s12lbl.pdf
Starlix (nateglinide) Label
http://www.fda.gov/cder/foi/label/2000/21204lbl.pdf
You can search for information about other drugs on the CDER New and Generic Drug Approvals web page. This is an alphabetical listing of most
recently approved prescription drugs. It is updated on a daily basis and contains links to labels, approval letters, and reviews of approved drugs.
To go to the New and Generic Drug Approval web site, use the following
link:
CDER New and Generic Drug Approvals
http://www.fda.gov/cder/approval/index.htm
[Top]
FDA Consumer Information about Diabetes Medications
FDA has consumer information about several new types of diabetes drugs.
Pharmacists from CDER's Drug Information Branch prepare these information
sheets based on the drug's approved package insert. For consumer information
about each of these products, use the following links:
Actos (pioglitazone) Consumer Information
http://www.fda.gov/cder/consumerinfo/druginfo/actos.HTM
Avandia (rosiglitazone) Consumer Information
http://www.fda.gov/cder/consumerinfo/druginfo/avandia.HTM
Starlix (nateglinide) Consumer Information
http://www.fda.gov/cder/consumerinfo/druginfo/starlix.HTM
To search the Consumer Drug Information Page for another medication,
use the following link:
FDA Consumer Drug Information
http://www.fda.gov/cder/consumerinfo/default.htm
[Top]
European version of labeling documents:
SPCs (for physicians) and PILs
(for patients).
Amaryl (glimepiride) SPC
http://emc.vhn.net/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
The SPC and PIL for medications approved in the UK may be found at the
electronic Medicines Compendium at the Medicines.org.uk website (http://emc.medicines.org.uk/)
The SPC for medications approved in Sweden may be found (in English) at
Summary of Products Characteristics at the Medical Products Agency website (http://www.mpa.se/eng/spc/index.shtml)
The SPC 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/DatasheetPage.htm)
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
