The Food and Drug Administration, the agency responsible for drug approval in the U.S., announced that it has received multiple reports of kidney problems, including renal failure, in patients taking Type 2 diabetes drug Byetta, according to a recently published article from Reuters.
The agency says it has received 78 reports of kidney-function problems between April 2005 and October of last year. Near 7 million prescriptions for Byetta, which is from companies Eli Lilly and Amylin Pharmaceuticals, were filled over that time period.
The drug had previously only been approved for patients in the U.S. that had trouble maintaining blood sugar control and was to be taken in concert with other diabetes drugs. However, the drug recently won FDA approval as a stand-alone treatment.
A spokesman for the companies said that clinical trial data for the drug showed no direct negative impact on the kidneys, noting that the diabetes is actually a leading cause of kidney problems.
The majority of the problems occurred in patients that had pre-existing kidney disease or were at risk of developing problems, according to another article from Healthday News. An FDA official said that patients and doctors should be on the lookout for symptoms of kidney problems, which include fatigue, swelling of the hands and feet, as well as lower back aches and digestive troubles. Symptoms also include changes to the amount and how frequently they urinate, as well as the color of the urine.
Side effects of the drug — nausea, vomiting and diarrhea — may also contribute to the development of kidney problems, which can in turn result in potentially life-threatening conditions.
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