The Cochran Firm Legal Blog

Yesterday, the FDA sent a letter to healthcare professionals about revisions to Byetta’s labeling. It includes information about reports received by the FDA of kidney function being affected, even to the point of acute renal insufficiency or renal failure.

What is Byetta?

Byetta is an injectable diabetes drug designed to help control blood sugar. It helps the pancreas to produce insulin, the substance that a non-diabetic person produces to keep blood sugar from becoming too high.

It is prescribed for Type 2 (adult onset ) diabetes which is non-insulin dependent. In other words, a person with Type 2 diabetes can produce some insulin, but maybe not enough; whereas a person with Type 1 (Juvenile) diabetes cannot produce any insulin at all.

Byetta is meant to be used within an hour of eating a meal, but not after a meal. The increased insulin it stimulates helps the body digest the meal without shooting blood sugar too high. A patient on Byetta is required to check their own blood sugar as well as having it regularly tested by their doctor.

Reports of Kidney Problems

Between April 2005 and October 2008, the FDA received 78 reports of changed kidney function in patients on Byetta, including 62 reports of acute renal failure and 16 of renal insufficiency. Some of those patients had either one or more risk factors for kidney problems, or a pre-existing kidney disease.

Drug Label Changes

The new labeling will help healthcare professionals assess the risks and benefits for each patient. It will include:

• Reports of acute renal failure with specific blood test information, demonstrating that Byetta poses risk to someone with severe renal impairment or end-stage renal disease.
• Cautions relative to any increase of Byetta dosage.
• Recommendations on monitoring diabetic patients using Byetta, so as to catch any kidney dysfunction early
• More information in the patient Medication Guide to help people understand Byetta’s risks.

Every drug has side effects and risks, which is why so many are obtainable only with a prescription. But when given to a patient with appropriate health conditions, no drug should be dangerous, especially when both doctor and patient are well-informed of the possible risks.

The FDA works to make sure all important drug information is properly disseminated and when it finds that more should be made available, it asks for a label adjustment. It may ask for a “black box” warning, the most urgent type of warning. Any negative reports on a drug’s effects are noted and if the FDA receives too many reports of serious negative drug effects, it may decide that the drug is defective. The next step would be to work with the drug manufacturer on a recall process. Byetta is not determined to be a defective drug; it is only changing its labeling.

If you have been harmed by a defective drug, you may want to learn more about your legal rights and options. Please contact our law office today to schedule a free case review.

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