Login
Subscribe
Do not use exenatide (BYDUREON) because it does not reduce the risks of heart attack and stroke for type 2 diabetes patients, and it carries risks of pancreatitis and, possibly, thyroid cancer.
In January 2012, the Food and Drug Administration (FDA) approved BYDUREON to improve blood sugar control, with a better diet and more exercise, in patients with type 2 diabetes. But as with other diabetes drugs, there is no evidence that it mitigates heart attacks and strokes in people with this...
Do not use exenatide (BYDUREON) because it does not reduce the risks of heart attack and stroke for type 2 diabetes patients, and it carries risks of pancreatitis and, possibly, thyroid cancer.
In January 2012, the Food and Drug Administration (FDA) approved BYDUREON to improve blood sugar control, with a better diet and more exercise, in patients with type 2 diabetes. But as with other diabetes drugs, there is no evidence that it mitigates heart attacks and strokes in people with this condition.
BYDUREON, a member of the glucagon-like peptide (GLP-1) agonists family, is a long-acting form of BYETTA (approved by the FDA in October 2009 and also a “Do Not Use” drug). The other GLP-1 agonist currently available in the U.S. is liraglutide (VICTOZA, also a “Do Not Use” drug). Because BYDUREON and BYETTA are the same chemical, exenatide, they should not be used together.
|
Preventing and treating type 2 diabetes without drugs The Health Research Group has long encouraged a greater role for lifestyle changes in the prevention and treatment of type 2 diabetes. Lifestyle changes that include a better diet and more aerobic (walking, running and bicycling) and resistance-training (weight lifting) exercise can control blood sugar levels in those with type 2 diabetes. Blood levels of hemoglobin A1c (HbA1c, a measure of your average blood glucose control over the last two to three months) are an indicator of blood sugar control. Six percent is usually considered a normal HbA1c, and the target HbA1c in patients with type 2 diabetes is below 7 percent. Unfortunately, even when patients have controlled their HbA1c and blood sugar levels, it has not translated into what is most important to type 2 diabetes patients: reducing the risks of heart attack and stroke. The drugs approved by the Food and Drug Administration for blood sugar control do not reduce these risks and must carry a statement in their product labels saying so. A gold-standard randomized trial published in the February 2002 New England Journal of Medicine found that lifestyle changes were significantly better than the diabetes drug metformin (GLUCOPHAGE) in preventing the development of type 2 diabetes as measured by blood sugar levels. In this trial, the incidence of type 2 diabetes was reduced by 58 percent in the lifestyle change group and by 31 percent in the group receiving metformin, compared to the placebo group (relative risk). Both lifestyle changes and metformin were effective, but the lifestyle modification was better than the drug. The lifestyle changes in this trial amounted to a low-calorie, low-fat diet (with a goal of achieving 7 percent weight loss) and physical activity of moderate intensity (such as brisk walking) for at least 20 minutes per day. In September 2007, an Annals of Internal Medicine study examined the effects of aerobic training, resistance training or both on blood sugar control in patients with type 2 diabetes. In the group that used both aerobic and resistance training, HbA1c decreased by about 0.5 percent (with a range from 0.14 to 0.87 percent) compared to HbA1c in a group of type 2 diabetics who remained inactive during the study. The exercise group participants exercised three times weekly, and training progressed in duration and intensity. For those preventing or managing type 2 diabetes with exercise, there is an additional benefit: Your heart health will improve. |
Heart attack and stroke
The “Warning and Precautions” section of BYDUREON’s FDA-approved product label states:
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction [heart attack and stroke] with BYDUREON or any other antidiabetic drug.
This statement reflects the lack of evidence that exenatide reduces the risks important to type 2 diabetics: heart attack and stroke. Exenatide will manage the symptoms of high blood sugar but so will all of the other drugs approved for blood sugar control in patients with type 2 diabetes.
|
FDA Black Box Warning RISK OF THYROID C-CELL TUMORS Exenatide extended-release causes thyroid C-cell tumors at clinically relevant exposures in rats. It is unknown whether BYDUREON causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies. BYDUREON is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). |
Important safety concerns
There are several important safety concerns associated with the use of BYDUREON. First, there is the possible risk of thyroid gland tumors, including malignancy. In preapproval animal studies, BYDUREON caused rats to develop statistically significant increases in tumors of the thyroid gland, including C-cell adenomas and C-cell carcinomas (cancerous and benign tumors). It is not known if BYDUREON will cause thyroid tumors or a serious type of thyroid cancer called medullary thyroid cancer in humans, but there is evidence that the related drug liraglutide is associated with increased thyroid tumors in humans. Because of the seriousness of the results of the preapproval animal studies, the FDA required BYDUREON’s manufacturer to display a black box warning in the drug’s product label about the risk of thyroid cancer. (See BYDUREON's Black Box Warning)
Black box warnings are usually reserved for drugs that have caused serious injury or deaths in humans. The FDA may require a black box warning based on animal studies if the seriousness of a possible adverse effect is of great concern. This is the case with BYDUREON.
The second important safety concern with the use of BYDUREON is inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Some medical conditions can increase the likelihood of getting pancreatitis.
It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking BYDUREON. Conditions that may raise a patient’s risk of pancreatitis include gallstones, a history of alcoholism and high blood triglyceride levels.
Medication Guide
The FDA can require a Medication Guide for drugs that present serious public health concerns. Medication Guides are FDA-approved, and the agency’s regulations require that pharmacies distribute them with each new and refill prescription. The Medication Guide for BYDUREON can be found at www.fda.gov/Drugs/DrugSafety/ucm085729.htm.
Medication Guides give patients useful and accurate risk information about drugs. Patients should read the Medication Guide each time it is issued. It may contain new data.
BYDUREON’s Medication Guide warns of three other adverse effects. Low blood sugar may indicate overmedication, and patients should check with their doctors if they experience symptoms. Kidney problems can occur because of the gastrointestinal adverse effects caused by BYDUREON. Nausea, vomiting and diarrhea all cause loss of fluids, which can lead to kidney failure. If these conditions do not go away or if you cannot drink liquids, call your health care provider. Finally, severe allergic reactions may appear as breathing difficulty, fainting, itching or hives. In this case, patients should stop taking BYDUREON and seek immediate medical help.
What You Can Do
You should not use BYDUREON.
You should stop taking BYDUREON and call your physician immediately if you have severe pain in your stomach area that will not go away. Possibly a symptom of pancreatitis, the pain may occur with or without vomiting and may be felt from your abdomen through to your back.
Consumers may report serious adverse events or product quality problems to the FDA’s MedWatch Adverse Event Reporting program.
- Online: www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
- Regular mail: Use postage-paid, pre-addressed FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: (800) FDA-0178
- Phone: (800) FDA-1088
