FDA Approves a Highly Questionable New Diabetes Drug, Invokana

The FDA just gave its approval to the first drug in a new class of diabetes drugs, Johnson & Johnson's canagliflozin, which will be marketed in the U.S. as Invokana.New York Times: FDA Approves a New Diabetes Drug From J.&J. (May require subscription)Reuters: U.S. FDA approves Johnson & Johnson diabetes drug, canagliflozinThis class of drugs, the sodium-glucose co-transporter-2 (SGLT2) inhibitors, lowers blood sugar by blocking reabsorption of glucose by the kidney and increasing its excretion in urine. The manufacturer also claims that it causes weight loss--always a potent selling point for a diabetes drug.As is the case with all new diabetes drugs, now that the drug is approved, drug company flacks will start saturation bombing family physicians with materials that make it sound like they should put every patient with Type 2 on this wonderful, new drug, which is priced at $8.77 a pill or $263.10 for a monthly supply.They shouldn't.The committee of "experts" who reviewed this drug were ambivalent about it because the company's own, [most likely, statistically manipulated], clinical study of patients at especially high risk of cardiovascular disease showed that within the first 30 days, 13 patients taking canagliflozin suffered a major cardiovascular event [mainly strokes and some heart attacks] compared with just one patient taking a placebo. After that, the imbalance was reversed, though the drug then caused a slight increase in LDL cholesterol. However, as the...
Source: Diabetes Update - Category: Diabetes Authors: Source Type: blogs