FDA Issues Warning for 2 Diabetes Drugs Linked to Increased Heart Failure Risk

heart pain

Following the results of 2 clinical trials, the Food and Drug Administration has issued warnings for diabetes medications containing saxagliptin and alogliptin. These medications have been shown to increase the risk of heart failure, especially for those who already suffer from heart or kidney disease.

An FDA statement notes:

“Healthcare professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control. If a patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.”

  • The trial focusing on saxagliptin found that 3.5% of patients receiving the drug were hospitalized for heart failure. This is compared to 2.8% who received a placebo. This means that 35 out of every 1,000 patients on the medication were hospitalized for heart failure, compared with 28 out of every 1,000 patients not taking it.
  • For alogliptin, 3.9% of patients receiving the drug were hospitalized for heart failure, compared with 3.3% receiving a placebo. This means that 39 out of every 1,000 patients on the medication were hospitalized for heart failure, compared with 33 out of every 1,000 patients not taking it.

In light of the results, the FDA is asking health care professionals to reconsider the prescribing of the medications containing saxagliptin and alogliptin for patients who develop heart failure, while monitoring their diabetes control.

Needless to say, anyone taking the medications should contact their doctor if they develop signs and symptoms of heart failure, but shouldn’t stop taking them without first consulting a doctor. Here is a list of some symptoms of heart failure:

  • “Shortness of breath (dyspnea) when you exert yourself or when you lie down

  • Fatigue and weakness

  • Swelling (edema) in your legs, ankles and feet

  • Rapid or irregular heartbeat

  • Reduced ability to exercise

  • Persistent cough or wheezing with white or pink blood-tinged phlegm

  • Increased need to urinate at night

  • Swelling of your abdomen (ascites)

  • Sudden weight gain from fluid retention

  • Lack of appetite and nausea

  • Difficulty concentrating or decreased alertness

  • Sudden, severe shortness of breath and coughing up pink, foamy mucus

  • Chest pain if your heart failure is caused by a heart attack”

Director of inpatient diabetes at Lenox Hill Hospital in New York City Dr. Minisha Sood, said:

“At this time, it is unclear whether this is a ‘class effect’ which applies to all drugs in the DPP-4 inhibitor category or only saxagliptin and alogliptin. It also remains unclear at this time whether this advice applies to patients at relatively low risk for heart disease.”

Simple Steps to Avoiding Diabetes

Of course anyone can take measures to prevent Type 2 diabetes, just with simple lifestyle changes. Try implementing some of these simple improvements to help avoid diabetes and numerous other ailments.

  • Eat healthy, low-glycemic index foods and avoid simple carbohydrates and refined sugars.
  • Eat more leafy greens, healthful fats like Omega 3’s and Omega 6’s, and lean proteins, such as chicken or turkey.
  • Boost gut health by including more probiotics, kim chi, and other fermented foods.
  • Look into supplements, including cinnamon, omega-3 fatty acids, alpha lipoic acid, chromium, coenzyme Q10, garlic, and magnesium. Cinnamon for diabetes may be especially helpful.
  • Maintain a healthy weight.
  • Perform a *healthy detox* every year – one that works for you.
  • Reduce stress, and thus cortisol production.
  • Exercise regularly.