Sections

Alphabetical list:

A B C D E F G H I J K L M N O P R S T U V W X Y Q Z 1 2 3 4 5 6 7 8 9

News: November 21, 2009

Diabetes Drug Byetta Linked to Kidney Problems

November 21, 2009

The FDA has received 78 reports of kidney problems related to Byetta, a drug by Amylin Pharmaceuticals and Eli-Lilly prescribed to treat type 2 diabetes. With the new findings, the drug's label will be updated to warn doctors and patients about this possible side effect.

Byetta (exenatide) was approved in 2005. It's known as an incretin mimetic, which copies the action of incretin GLP-1, a hormone that is released in response to eating food which causes insulin to be secreted from the pancreas to lower blood glucose. The drug is injected twice a day, similar to insulin.

The drug recently was approved as a stand-alone treatment for controlling blood sugar, whereas previously it was prescribed for patients also on other diabetic therapies.

The reports of kidney failure were filed between April 2005 and October 2008. Sixty-two of the cases were for acute renal failure and 16 were cases of renal insufficiency. Most of the problems occurred in patients with pre-existing kidney disease or one or more risk factors for developing kidney problems. 91% of the patients were hospitalized, 18 required dialysis, 2 had kidney transplants, and 4 died. 80% stopped taking Byetta, and half of those patients had improvements to kidney function after discontinuing the drug.

Between 2005 and 2008, approximately 7 million prescriptions were written for Byetta. The FDA said, "Therefore, the 78 reported cases of altered renal funcion represent a small percentage of the total number of patients who have used the drug."

Some of the side effects of Byetta can contribute to kidney problems. For example, diarrhea, nausea and vomiting can lead to dehydration. Patients are encouraged to ask their physicians about their kidney function before taking Byetta and to monitor for signs and symptoms while taking the drug. Symptoms of kidney disease include changes in urine color, swelling in the feet and legs, fatigue, nausea or vomiting, and dull ache in the mid to lower back. If left untreated, kidney damage can worsen and lead to kidney failure.

Kidney malfunction may also occur as a consequence of diabetes itself, other chronic conditions, such as pancreatitis and hypertension. Concomitant use of certain medications (nonsteroidal anti-inflammatory drugs, diuretics, and antihypertensives) can also lead to kidney problems. Discontinuation of Byetta should only be considered if kidney dysfunction cannot be explained by these or other causes.

The FDA is advising physicians to avoid prescribing Byetta for patients with severe renal impairment, identified as creatinine clearance less than 30 mL per minute, or end-stage renal disease. It also recommends using caution when initiating or increasing doses from 5 micrograms to 10 micrograms in patients with moderate renal impairment. Physicians should monitor patients for the development of kidney dysfunction while on Byetta.

In 2007, Byetta was linked to a higher risk of acute pancreatitis, a potentially life-threatening inflammation of the pancreas. In October 2007 and August 2008, the FDA issued safety alerts about the reports that included cases of hemorrhagic pancreatitis and nectrotizing pancreatitis, which can be fatal. The symptoms of pancreatitis include nausea, vomiting, severe abdominal pain, a rise or fall in blood pressure, and increase heart or respiratory rates.

Adverse events for any medication should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Denise Reynolds RD LDN



Archive issues: (50)

Archive list: [1] 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

December 20, 2009 | Wii, Xbox 360 and Other Video Games Offer Some Benefits

Wii, Xbox 360, PlayStation, and other video games are hot on holiday gift lists, but some parents wonder whether these games offer any benefits or are detrimental to kids. The results of a new study may put some minds at ease, while others may not.  According to the findings reported in the latest issue of Current Directions in Psychological Science, regular gamers transfer their skills as fast, accurate information ...

December 18, 2009 | Should You Be Shoveling Snow?

Yes, the weather outside is frightful, and soon you will have to think about shoveling snow. But should you be the one doing the work? Who should and should not shovel snow, and how can you do it safely?  Every winter, approximately 1,200 Americans die from a heart ...

December 17, 2009 | Athletes who take NSAID's to prevent pain may be doing more harm than good

According to Stuart Warden, a researcher who studies musculoskeletal health and sports medicine, athletes who ritualistically take NSAID's to prevent post event and workout soreness and inflammation may be depriving the body of healing, in addition to risking other long term health problems. Taking anti inflammatory medications before running ...

Archive list: [1] 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Related articles:

Treatment - bladder distension

  Bladder distension (a procedure which stretches the bladder capacity, done under general anaesthesia) has shown some success in reducing urinary frequency and giving pain relief to patients. However, many experts still cannot understand precisely how this can cause pain relief. Recent studies showing that pressure on pelvic trigger points can relieve symptoms may be connected. Unfortunately, the relief achieved by bladder distensions ...

Section: Interstitial cystitis

Chronic prostatitis/chronic pelvic pain syndrome - treatment

  No treatment required. It is standard practice for men with infertility and category IV prostatitis to be given a trial of antibiotics and/or anti-inflammatories however evidence for efficacy are weak. Since signs of asymptomatic prostatic inflammation may sometimes be associated with prostate cancer, this can be addressed by tests that assess the ratio of free-to-total PSA. The results of these tests were significantly different in prostate cancer and category IV ...

Section: Prostatitis

Chronic prostatitis/chronic pelvic pain syndrome - diagnosis

  There are no definitive diagnostic tests for CP/CPPS. This is a poorly understood disorder, even though it accounts for 90%-95% of prostatitis diagnoses. It is found in men of any age, with the peak onset in the early 30s. CP/CPPS may be inflammatory (Category IIIa) or non-inflammatory (Category IIIb), based on levels of pus cells in expressed prostatic secretions (EPS), but these subcategories are of limited use clinically. In the inflammatory form, urine, semen, and other fluids from the prostate contain pus cells (dead white blood cells or WBCs), whereas in the ...

Section: Prostatitis

News

December 20, 2009

Wii, Xbox 360 and Other Video Games Offer Some Benefits

Wii, Xbox 360, PlayStation, and other video games are hot on holiday gift lists, but some parents wonder whether these games offer any benefits or are detrimental to kids. The results of a new study may put some minds ...

December 18, 2009

Should You Be Shoveling Snow?

Yes, the weather outside is frightful, and soon you will have to think about shoveling snow. But should you be the one doing the work? Who should and should not shovel snow, and how can you do it safely?  Every winter, approximately 1,200 ...

December 17, 2009

Athletes who take NSAID's to prevent pain may be doing more harm than good

According to Stuart Warden, a researcher who studies musculoskeletal health and sports medicine, athletes who ritualistically take NSAID's to prevent post event and workout soreness and inflammation may be depriving the body of healing, in addition ...

Blogroll