Drug Treatments for Type 2 Diabetes - Review
2011
2011
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Discuss with your doctor before taking any alternative medicine. This article is for
reference only, it is not a medical advice. All rights reserved. Do not copy this article to
other website or blog.
reference only, it is not a medical advice. All rights reserved. Do not copy this article to
other website or blog.
 |  |  |  |  |
IMPORTANT INFORMATION ABOUT DRUG TREATMENT / PRODUCT SIDE EFFECTS
Actos
On September 17, 2010, the FDA started an Actos safety review after preliminary data from a study demonstrated that
the risk of bladder cancer increases with increasing dose and duration of Actos use. On June 15, 2011, the FDA issued
another safety communication stating that use of Actos for more than 12 months may be associated with an increased
risk of bladder cancer. When compared to persons never treated with Actos, taking Actos for more than 12 months was
associated with a 40 percent increase in the risk of developing bladder cancer. [Parker Waichman Alonso LLP; New
York (PRWEB) September 06, 2011]
Metformin
[2005 FDA Science Forum ] Lactic acidosis is a serious toxicity known to be associated with the use of some of the
nucleoside reverse transcriptase inhibitors (NRTIs) and is believed to result from mitochondrial DNA depletion, and
downstream effects on oxidative metabolism. Metformin's lactic acidosis appears to develop in patients with underlying
medical conditions, most notably renal insufficiency. Lactic acidosis with phenformin may be due to disruption of
oxidative phosphorylation in mitochondria. Lactic acidosis with metformin is probably due to back-up of lactate from
reduced gluconeogenesis. These two mechanisms are not mutually exclusive.
Avandia, Avandamet, and Avandaryl
Safety Announcement
[FDA 5-18-2011] The U.S. Food and Drug Administration (FDA) is informing the public of new restrictions to the
prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the
names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order
to prescribe and receive these drugs.
The new restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS)—a program FDA may require to
manage serious risks of marketed drugs. The restrictions are based on data that suggested an elevated risk of heart
attacks in patients treated with rosiglitazone. The decision to restrict access to rosiglitazone medicines was made on
September 23, 20101.
FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a
Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three
rosiglitazone products.
The REMS, called the Avandia-Rosiglitazone Medicines Access Program (PDF - 3MB), limits the use of rosiglitazone
medicines to:
* Patients already being successfully treated with these medicines.
* Patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their
healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or
Duetact).
Healthcare providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to
prescribe and receive rosiglitazone medicines. After November 18, 2011, rosiglitazone medicines will no longer be
available through retail pharmacies. Patients who are enrolled in the Avandia-Rosiglitazone Medicines Access Program
will receive their medicine by mail order through specially certified pharmacies participating in the program.
Januvia and Janumet
[FDA 09-25-2009]
FDA is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include
information on reported cases of acute pancreatitis in patients using these products.
Sitagliptin, the first in a new class of diabetic drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, is approved as an
adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in
patients using sitagliptin, were reported to the Agency between October 16, 2006 and February 9, 2009. Based on
these reports.
_____________________________________________________________________________________________
Note: Not all FDA alerts related to diabetic drugs are listed above. Users must discuss with their medical
doctors before taking any drug treatments.
Actos
On September 17, 2010, the FDA started an Actos safety review after preliminary data from a study demonstrated that
the risk of bladder cancer increases with increasing dose and duration of Actos use. On June 15, 2011, the FDA issued
another safety communication stating that use of Actos for more than 12 months may be associated with an increased
risk of bladder cancer. When compared to persons never treated with Actos, taking Actos for more than 12 months was
associated with a 40 percent increase in the risk of developing bladder cancer. [Parker Waichman Alonso LLP; New
York (PRWEB) September 06, 2011]
Metformin
[2005 FDA Science Forum ] Lactic acidosis is a serious toxicity known to be associated with the use of some of the
nucleoside reverse transcriptase inhibitors (NRTIs) and is believed to result from mitochondrial DNA depletion, and
downstream effects on oxidative metabolism. Metformin's lactic acidosis appears to develop in patients with underlying
medical conditions, most notably renal insufficiency. Lactic acidosis with phenformin may be due to disruption of
oxidative phosphorylation in mitochondria. Lactic acidosis with metformin is probably due to back-up of lactate from
reduced gluconeogenesis. These two mechanisms are not mutually exclusive.
Avandia, Avandamet, and Avandaryl
Safety Announcement
[FDA 5-18-2011] The U.S. Food and Drug Administration (FDA) is informing the public of new restrictions to the
prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the
names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order
to prescribe and receive these drugs.
The new restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS)—a program FDA may require to
manage serious risks of marketed drugs. The restrictions are based on data that suggested an elevated risk of heart
attacks in patients treated with rosiglitazone. The decision to restrict access to rosiglitazone medicines was made on
September 23, 20101.
FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a
Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three
rosiglitazone products.
The REMS, called the Avandia-Rosiglitazone Medicines Access Program (PDF - 3MB), limits the use of rosiglitazone
medicines to:
* Patients already being successfully treated with these medicines.
* Patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their
healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or
Duetact).
Healthcare providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to
prescribe and receive rosiglitazone medicines. After November 18, 2011, rosiglitazone medicines will no longer be
available through retail pharmacies. Patients who are enrolled in the Avandia-Rosiglitazone Medicines Access Program
will receive their medicine by mail order through specially certified pharmacies participating in the program.
Januvia and Janumet
[FDA 09-25-2009]
FDA is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include
information on reported cases of acute pancreatitis in patients using these products.
Sitagliptin, the first in a new class of diabetic drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, is approved as an
adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in
patients using sitagliptin, were reported to the Agency between October 16, 2006 and February 9, 2009. Based on
these reports.
_____________________________________________________________________________________________
Note: Not all FDA alerts related to diabetic drugs are listed above. Users must discuss with their medical
doctors before taking any drug treatments.
|
Drug Cominbational Treatments
Metformin has been "habitably" combined with other drug substances, such as glyburide (Glucovance®), pioglitazone (Actoplus Met®), sitagliptin
(Janumet®), saxagliptin (Kombiglyze XR®), GLP-1 receptor agonists and insulin to form various drug treatments. But, some drug combinational
treatments with metformin increase the risk of stomach problems, but not as much as metformin alone. Pioglitazone combinational treatments can
add to the risk of hip and non-hip fractures, especially for women and may cause more weight gain than other medicines. Some combinational
treatments with drugs such as sulfonylureas may increase the risk of low blood sugar.
SOURCE: Effective Health Care Program, Agency for Healthcare Research and Quality, Consumer Guide, June 30, 2011, Online Publication
Metformin has been "habitably" combined with other drug substances, such as glyburide (Glucovance®), pioglitazone (Actoplus Met®), sitagliptin
(Janumet®), saxagliptin (Kombiglyze XR®), GLP-1 receptor agonists and insulin to form various drug treatments. But, some drug combinational
treatments with metformin increase the risk of stomach problems, but not as much as metformin alone. Pioglitazone combinational treatments can
add to the risk of hip and non-hip fractures, especially for women and may cause more weight gain than other medicines. Some combinational
treatments with drugs such as sulfonylureas may increase the risk of low blood sugar.
SOURCE: Effective Health Care Program, Agency for Healthcare Research and Quality, Consumer Guide, June 30, 2011, Online Publication
The key benefits and side effects of popular drug treatments (products) for diabetes are summarized in the
following table:
following table:
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N.B. There are many more side effects of the drug treatments. Only the key side effects are listed for comparison and contrast. Users must discuss with their
medical doctors before taking any medicine.
medical doctors before taking any medicine.