Public Warnings & Possible Side-Effects          Back to Home Page
We get many calls at Beta Therapy asking us about diabetic drugs vs. Eleotin. We, by law, are not allowed to give any medical advice so we'll let the media do it for us. Read what is being said about various diabetes drugs from trusted sources such as Drugs.com, WebMD.com, FDA.gov & more to weigh the pros and cons about diabetes drugs yourself to make your own informed decision. 

POSSIBLE SIDE-EFFECTS
Sore throat, muscle pain, or tooth problems may occur. Fast/pounding heartbeat, changes in menstrual cycles, new/worsening vision problems (e.g., color or night vision problems), bone fracture. Dark urine, yellowing of eyes/skin, persistent nausea/vomiting, stomach/abdominal pain. 

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
Credit: WebMD.com

Source: Physicians Committee for Responsible Medicine

FDA Issues Warning for Diabetes Drug

TUESDAY, Nov. 3 (HealthDay News) -- Reports about possible kidney problems, including renal failure, in people taking the diabetes drug exenatide (Byetta) have prompted changes to the drug's prescribing information, the U.S. Food and Drug Administration said Monday.

From April 2005 to October 2008, the FDA received 78 reports of kidney function problems in patients taking Byetta. Most of the problems occurred in patients with pre-existing kidney disease or one or more risk factors for developing kidney problems. Byetta is prescribed for type 2 diabetes; 7 million prescriptions were filled between April 2005 and September 2008, according to the agency.

"Health-care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems," Dr. Amy Egan, of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research, said in an FDA news release.

"Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in the mid- to lower back," Egan said. She advised patients with any of these symptoms to immediately consult with a health-care professional.

Byetta, made by San Diego-based Amylin Pharmaceuticals Inc., is used to control blood sugar levels.

Nausea, vomiting and diarrhea are the most common side effects associated with the drug. These side effects may contribute to the development of kidney malfunction, which can lead to a build-up of waste products in the blood, resulting in serious illness and potentially life-threatening conditions.

[Posted 09/25/2009] FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009. It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis.
Source: FDA.gov

Side Effects May Include:
Symptoms may include chills, cold sweat, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands or feet, or hunger.
Source: Drugs.com

FDA WARNING
FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects.

FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus. Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues.

The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA's MedWatch Adverse Event Reporting Program.
Source: FDA.Gov