(RxWiki News) Before a Rx can make it to pharmacy shelves, it has to go through a strict testing process. Sometimes, the Rx is found to pose serious risks to patients, as was the case with a new diabetes drug.
The US Food and Drug Administration (FDA) is currently reviewing a Rx for type 2 diabetes called canagliflozin. Researchers found that the Rx was able to lower blood sugar levels but may increase the risk of heart, kidney and bone-related problems.
On January 10, a panel of non-FDA experts is scheduled to vote on the safety and effectiveness of canagliflozin - which is being developed by Johnson & Johnson. If approved, the company will market the Rx as Invokana.
"Ask your doctor about diabetes Rx options."
The expert panel will be asked to discuss the potential risks of the drug. While the FDA is not required to follow the panel's recommendations, it usually does.
Canagliflozin has been studied in nine Phase 2 and Phase 3 trials. In these trials, canagliflozin was compared to placebo (sugar pill) and other diabetes drugs.
Most results showed that canagliflozin was effective at lowering blood sugar. However, some findings have raised concern about the drug's safety.
During trials, canagliflozin raised bad cholesterol in some patients, which may put these patients at risk of stroke and other heart-related problems. Results also showed that canagliflozin may be linked to kidney problems, urinary tract infections and reduced bone mineral density, which can increase the risk of fracture.
Researchers also looked at the cancer risk associated with canagliflozin treatment. They did not find that the drug increased the risk of cancer.
Type 2 diabetes is a disease characterized by levels of sugar in the blood. The main goal of diabetes treatment is to control these blood sugar levels. For some patients, diet and exercise is enough to bring blood sugar to normal levels. However, other patients may need the help of medications on top of these lifestyle changes.
Canagliflozin is part of a new class of drugs called subtype 2 sodium-glucose transport protein (SGLT2) inhibitors. These drugs lower blood sugar by increasing the amount of sugar that is passed out of the body through urine.
Earlier this year, the FDA rejected a similar drug - called dapagliflozin - by AstraZeneca and Bristol-Myers Squibb. While dapagliflozin was rejected in the US over safety concerns, it has been approved in Europe.