An increased risk of heart attacks, strokes and deaths may hurt the chances of Johnson & Johnson’s experimental diabetes drug canagliflozin being approved by the Food and Drug Administration (FDA). Data from nine large patient studies showed the drug raised levels of LDL, or bad cholesterol, and slightly increased risk of cardiovascular events or death compared to two other types of diabetes medications. The drug was also tied to urinary tract infections and fungal infections in the genital area, likely because the drug works by increasing the amount of sugar excreted in the urine, and germs thrive on that sugar.
An FDA advisory panel is scheduled to review data on canaglitflozin this week and will decide whether to recommend that the agency approve the drug. The FDA is not required to follow the recommendations of its advisory panels, but it usually does.
The FDA has cracked down on type 2 diabetes drugs, requesting drug companies with diabetes treatments in development to track cardiac side effects in particular when testing new drugs. The push was initiated after the FDA placed severe restrictions on the diabetes drug Avandia after it was linked to fatal heart attacks.
A year later, the FDA issued a warning on the drug Actos after it was tied to bladder cancer. The risk grew substantially in patients who used the drug for a year or more.
The FDA has set a tentative date of March 31 to decide whether to approve canaglitflozin. If approved, Johnson & Johnson says it will sell it under the name Invokana.