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The FDA has approved a Pregnancy Category B rating for insulin aspart (rDNA origin) injection (NovoLog, Novo Nordisk). This rating indicates that adequate studies of pregnant women with type-1 diabetes have shown that Novo-Log does not pose an increased risk to the unborn baby. Previously, the product had a Category C rating, which indicated that adverse effects on the fetus had occurred in animal studies and that adequate and well-controlled studies in pregnant women had not been conducted to demonstrate the product’s safety.
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The FDA has issued a safety alert about the diabetes drug rosiglitazone (Generic Avandia, GlaxoSmithKline) after data from controlled clinical trials showed a possibly significant increase in cardiovascular adverse drug events. However, other data from long-term clinical trials provide contradictory evidence.

Analyses of all available data are ongoing. It is unclear whether generic pioglitazone (Actos tablet, Takeda/Eli Lilly), another diabetes treatment from the same drug class, poses similar risks.

The FDA cautions that there is an inherent risk associated with switching patients from one treatment to another, even in the absence of risks associated with particular treatments. Thus, the FDA has not yet asked GlaxoSmithKline to take any specific action.

Rosiglitazone was approved in 1999 for the treatment of type-2 diabetes.

Dr. Robin Goland of Columbia University explains that patients with uncontrolled type-2 diabetes are at high risk for heart attack, and it is unclear whether and how much generic rosiglitazone affects this risk. A randomized, controlled trial might provide some answers.

Merck has announced the approval of sitagliptin plus generic metformin (Janumet), the first tablet to combine a dipeptidyl pepti-dase-4 (DPP-4) inhibitor for the treatment of type-2 diabetes. Sitagliptin (Janu-via, Merck) was approved for patients with type-2 diabetes in the U.S. in 2006 either as monotherapy or as combination therapy when added to either met-formin (Glucophage, Bristol-Myers Squibb), a glucose-lowering agent, or a thiazolidinedione such as drug rosiglitazone maleate (Avandia tablet, GlaxoSmithKline) or pioglitazone medication (Actos drug, Takeda/Eli Lilly).

Janumet is approved as an adjunct to diet and exercise to improve glycemic control in adult patients with type-2 diabetes whose glucose levels are not adequately controlled with metformin drug or sitagliptin alone or for those who are using sitagliptin and metformin. It is not indicated for type-1 diabetes or diabetic ketoacidosis.

The combination tablet targets diminished insulin release, uncontrolled production of glucose, and insulin resistance. The drug’s labeling contains a boxed warning about the risk of lactic acidosis.

More information on Janumet is presented in this month’s Pharmaceutical Approval Update column on page 290.

Manufacturers of some drugs approved to treat type-2 diabetes have agreed to add a boxed warning about the risk of heart failure.

After a review of postmarketing adverse event reports, the FDA determined that an updated label was needed for the entire thiazolidinedione class of anti-diabetic drugs, including three GlaxoSmithKline products—rosiglitazone (Avandia drags), rosiglitazone/ glim epiride (Avandaryl), and rosiglitazone/metformin (generic Avandamet)—as well as pioglitazone (Actos drags, Takeda/Eli Lilly) and pioglitazone/glimepiride (Duetact, Takeda). These drugs are used in conjunction with diet and exercise to improve blood glucose control in adults.

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Although some animal studies have suggested that selenium supplements may help prevent vascular complications in patients with diabetes, findings from the Nutritional Prevention of Cancer trial in 1,202 patients from dermatology clinics suggest otherwise. Not only did selenium not help, it might have even heightened the risk of diabetes.

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Hypertension, diabetes, and other conditions mean that patients must manage anywhere from two to a multitude of medications. It’s no wonder that some find it difficult to stick with their treatments.

Polypharmacy and complexity of regimens are two determinants of poor compliance.

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Amid growing evidence that the same abnormal clumping of proteins in Alzheimer’s disease also contributes to type-2 diabetes, scientists are reporting the discovery of a potent new compound that reduces formation of these amyloid plaques. The report cites evidence correlating increases in amyloid formation in the pancreas with increases in severity and in the rate of progression of type-2 diabetes.

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