ACTOplus met XR should not be taken by people who have heart failure, kidney disease, or metabolic acidosis (excessive acidity of the blood), or by people who drink excessive amounts of alcohol. People who take ACTOplus met XR should be screened for liver problems before and periodically while taking it, and people who already have liver disease should not take ACTOplus met XR.
Availability: ACTOplus met XR is available by prescription only and is expected to be on the market by the end of 2009.
Product: Saxagliptin (Onglyza)
Manufacturer: Bristol-Myers Squibb
(800) 321-1335
www.bms.com
AstraZeneca
(800) 236-9933
www.astrazeneca.com
What it does: Onglyza is the second drug — joining Merck’s sitaglipin (Januvia) — in a class called DPP-4 inhibitors to be approved by the FDA for the treatment of Type 2 diabetes. Like Januvia, it is currently approved only for use in adults. Onglyza can be taken alone or in combination with other diabetes drugs, including metformin, Actos, Avandia, and those in the sulfonylurea class, which includes glimepiride, glipizide, and glyburide. When taken with a sulfonylurea, a lower dose of Onglyza is recommended to prevent hypoglycemia (low blood glucose). Its use in combination with insulin has not been studied. Onglyza is taken once daily.
Availability: Onglyza is available in 2.5-mg or 5-mg tablets.
Drug labeling changes
Product: Glimepiride (Amaryl)
Manufacturer: Sanofi-aventis
(800) 981-2491
www.sanofi-aventis.us
Reason for label change: Several classes of drugs that can increase the blood-glucose–lowering abilities of Amaryl, a sulfonylurea, to dangerous levels have already been identified by the FDA. This year the agency approved a labeling change that added disopyramide (Norpace and Rythmodan), fluoxetine (Prozac), and the quinolone family of antibiotics to the drugs that could cause hypoglycemia when taken in combination with Amaryl.
Product: Glyburide (Diabeta, Glynase, Micronase)
Manufacturer: various
Reason for label change: The drug glyburide, a sulfonylurea, is what is called “protein bound.” If taken with other drugs that are also protein bound — such as the non-steroidal anti-inflammatory drugs (NSAIDs), which include Celebrex, Motrin, Aleve, and aspirin — the risk of developing hypoglycemia is increased. The labeling change states that people who use glyburide with other protein-bound drugs should be observed closely for low blood glucose.
Product: Insulin aspart (NovoLog)
Manufacturer: Novo Nordisk
(800) 727-6500
www.novonordisk.com
