AACE Patient Safety - News
Response to oral bisphosphonates news reports

2010-03-11 11:44:53
By: Steven M. Petak, MD, JD, FACE, FCLM
President, American College of Endocrinology

During the past 24 hours, a number of news articles have reported on a potential link between oral bisphosphonates and increased fracture risk. The following is a quote from the FDA response to these news reports:

"Recent news reports have raised the question about whether there is an increased risk of this type of fracture in patients with osteoporosis using these medications. At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue."

The FDA Advises the following to healthcare professionals and their patients:

Healthcare professionals should continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should not stop taking their medication unless told to do so by their healthcare professional. Patients should talk to their healthcare professional about any concerns they have with these medications.

Additional Information for Patients

If you currently take an oral bisphosphonate you should:
  • Not stop taking your medication unless told to do so by your healthcare professional.
  • Talk to your healthcare professional if you develop new hip or thigh pain or have any concerns with your medications.
  • Report any side effects with your bisphosphonate medication to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box.
Additional Information for Healthcare Professionals

FDA recommends that healthcare professionals should:
  • Be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.
  • Continue to follow the recommendations in the drug label when prescribing oral bisphosphonates.
  • Discuss with patients the known benefits and potential risks with using oral bisphosphonates.
  • Report any adverse events with the use of oral bisphosphonates to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box.

Other articles of interest that you should be aware of:


USA TODAY: "Long-term use of osteoporosis drugs linked to hip breaks" http://www.usatoday.com/news/health/2010-03-11-bones11_st_N.htm

Reuters: "FDA rules out bisphosphonate, thigh fracture link" http://www.reuters.com/article/idUSTRE62A07Q20100311

AAOS Press Release: "Quantity vs. Quality: Long-Term Use of Bone-Building Osteoporosis Drugs May Affect Quality and Structural Integrity of Bone" http://www6.aaos.org/news/Pemr/releases/release.cfm?releasenum=877

 

There are 3 comments
Shashank R Joshi – India
August 27, 2008 - 14:51
Subject: Byetta and Pancreatitis-Practical Issues

Byetta and Pancreatitis - An Indian View
-- Dr. Shashank R Joshi, MD, DM, FACE, FRCP(Glg)
Endocrinologist, Mumbai India
Hon Editor, Journal of The Association of Physicians of India
Chair, Indian Chapter of AACE

Both your bezoar case and pancreatopathy make good reading. Incidentally, I reviewed global literature of all agents of diabetes and their impact on the pancreas. All secretagogues, as well as glinides, have case reports of pancreatitis reported. However, cause-effect relationship has never been proven, both in animal studies as well as reported anecdotes. In fact, the global reportage of pancreatitis is so small statistically that most cases had some other etiology for pancreatic injury. So currently we do not have sufficient evidence for pancreatic injury due to exenatide, but it stands to reason that in a predisposed individual it may act as a potential trigger for pancreatic injury.

The real worry will be the ongoing LAR preparation which is now under phase 3 trial program

Exenatide has some evidence to suggest that it may trigger a cholinergic response in alcoholics and that could be a beeptive pathway for pancreatic injury

So clinically, exenatide needs the following caveats prior to its use:
1) Chronic alcoholics or abuse
2) Refractory GERD
3) History of acute or chronic pancreatitis
4) Gall stones
5) Gastroparesis

One should avoid or exercise caution to use it in the above stated indications. Our institution avoids byetta in the above mentioned indications till further data will emerge

In India to date, one case of pancreatitis is reported.

Richard Hellman MD – NKC,
August 26, 2008 - 11:06
Subject: Byetta and stomach pain

Dear J.A. Moore,

Your question about Byetta and your nightly pain, which your doctor says is from your stomach, is a very important one, and thank you for asking it. It is not clear as to whether you are free of abdominal pain at this time. If you are pain free at this time, it may be difficult to be sure as to why you had pain in the past. If you are still having nightly pain, then my comments may be more relevant. Since I am not your doctor, I do not know enough about you to make a diagnosis or offer therapy, but I hope I can be helpful in some general suggestions. As we get older, the risk that a pain in the abdomen is a serious medical condition increases. But resistant pain in the abdomen can be from many causes: infections, such as a H.Pylori infection of the stomach, inflammation, such as pancreatitis, or a disease of the intestine called Crohn's disease, motility problems, such as gastroparesis, and other possibilities, vascular problems such as abdominal aneurysms, and also tumors, such as cancers of the stomach and of the pancreas. But there are other, much more common and simple problems, such as irritability of the gastrointestinal tract either due to drugs, such as metformin, or conditions as irritable bowel syndrome. I certainly could not tell from what you have said whether your problem is any of the above, or whether it is or was related to byetta.

But I think your questions are right-on and you should find out why you have had pain and whether it has anything to do with either byetta or to metformin. Your doctor should be able to do some screening tests for pancreatitis, and gastroenterologists can answer other of your questions, but I would encourage you to proceed to ask your health providers to answer your excellent questions.

You should also note that in the editorial I wrote on byetta, I discussed the responsibility of doctors to answer questions of this type. Thank you again for your excellent question. I hope I have been helpful.

J.A. MOORE – Washington DC
August 25, 2008 - 13:47
Subject: Byette

I have been taking Byette and have a nightly pain which the Dr says is my stomach. I am overweight and have high triglycerides. The Drs ran all kinds of tests on my gall bladder xrays plus other tests....including nuclear meds test. Gall bladder tests turned up negative. Then the Gastro Drs said it must be the valve on the stomach that's weak on diabetics and they gave me some medicine that kept me going to the toliet. I quit the medicine after almost a week of torture. But I took 3-Omega Oils capsules 3 times a day and Liptor and Tricore. My lipids were tested two weeks ago and the pain is gone and my Lipids very low in normal range with one type being under the allowable rate but my Endo Dr said that was OK. SHOULD I WORRY THAT I may have or had pancreatitis? I am still taking the Byette plus Metformin and Lantus..

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