FDA To Strengthen Warnings On Diabetes Drug After 2 More Deaths

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Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals;  Primary Care / General Practice;  GastroIntestinal / Gastroenterology
Article Date: 19 Aug 2008 - 2:00 PDT

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Futher to an alert it issued in October 2007, the US Food and Drug Administration (FDA) is planning to strengthen the warnings on diabetes drug Byetta (exenatide) after receiving reports of another 6 patients having to be admitted to hospital, two of whom died, because they got hemorrhagic or necrotizing pancreatitis after taking the drug.

The four surviving patients are now recovering, said the FDA. They are no longer taking Byetta, a drug that is administered by injection for treating adults with type 2 diabetes. The FDA said it was working with the drug maker, Amylin Pharmaceuticals Inc, to strengthen warnings in the PRECAUTIONS section of the product label about the risks of acute hemorrhagic or necrotizing pancreatitis.

Symptoms of acute hemorrhagic or necrotizing pancreatitis include persistent and severe abdominal pain that can spread to the back and may or may not be accompanied by nausea and vomiting. It is usually confirmed by blood tests that show high levels amylase and/or lipase, and by taking radiation images.

The number of reports sent to the FDA of patients falling ill with acute pancreatitis after taking Byetta since the drug has been on the market now totals 36. Back in October 2007, the FDA published an alert about 30 post marketing reports of acute pancreatitis in patients taking Byetta, and issued new Information for Healthcare Professionals. The agency said at the time that "an association between Byetta and acute pancreatitis is suspected in some of these cases".

Doctors should tell any patients on Byetta to seek medical attention immediately if they feel any persistent severe and unexplained abdominal pain, with or without vomiting.

The FDA said if doctors suspect a patient on Byetta has pancreatitis, they should promptly stop taking it, and any other potentially suspect drugs.

Unfortunately the signs and symptoms of the less severe form of pancreatitis and the acute hemorrhagic or necrotizing pancreatitis associated with Byetta are difficult to distinguish. If suspected pancreatitis is confirmed, then the patient should start appropriate treatment and be monitored carefully until recovery and they should not be given Byetta again.

Also, doctors should consider other antidiabetic therapies for patients with a history of pancreatitis said the FDA.

The agency said it is not advising doctors to stop prescribing Byetta and will be posting further advice and alert updates as they get more information.

Any serious or adverse events linked to the use the drug should be reported to the FDA via its MedWatch program at http://www.fda.gov/medwatch/report/hcp.htm.

In its earlier alert, the FDA said that in 27 of the 30 reported cases of acute pancreatitis after taking Byetta, the patients had at least one other risk factor for the condition, including gallstones, severe hypertriglyceridemia (high level of blood fats), and alcohol use.

21 of the patients were admitted to hospital and there were no reports of hemorrhagic or necrotizing pancreatitis, but 5 of the patients experienced serious complications including dehydration and renal (kidney) failure, suspected ileus (non-mechanical intestinal obstruction), phlegmon (infected and inflamed soft connective tissue), and ascites (too much fluid in the abdominal cavity).

In 6 of the cases, the patients either started to get symptoms of pancreatitis or existing symptoms got worse shortly after their dose of Byetta went up from 5 to 10 micrograms twice a day.

In the reported cases, 22 of the 30 patients improved after they stopped taking Byetta. But when three of the patients who stopped taking the drug then started it again, the symptoms of acute pancreatitis came back, including nausea and vomiting in two cases. The third patient just had abdominal pain that went away when they stopped taking the drug for good.

Click here for FDA Information for Healthcare Professionals on Byetta.

Source: FDA.

Written by: Catharine Paddock, PhD


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