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AACE Patient Safety - News

FDA Statement on Thyrogen

2010-05-26 16:59:45
By: Daniel Einhorn, MD, FACP, FACE
AACE President

Alan J. Garber, MD, PhD, FACE
AACE Liaison to the FDA and Editor, AACE Patient Safety Exchange

As a consequence of previous concerns raised regarding contamination resulting from particulate material in Thyrogen, the FDA and Genzyme have entered into a legal settlement which will limit the availability of a drug used in the treatment and diagnostic of thyroid cancer, Thyrogen, until certain manufacturing conditions have been corrected at the Genzyme facility in Allston Landing. The FDA has agreed to allow the distribution of Thyrogen at this time to patients to whom the treatment is deemed “medically necessary.”

Read the FDA Press Release on the settlement here: http://tinyurl.com/2fvg224

The criteria for "medically necessary," as established by the FDA include:

Patients undergoing initial radioiodine ablation of thyroid tissue remnants, post-thyroidectomy, deemed to be at significantly increased risk of side-effects/complications from undergoing thyroid hormone withdrawal.
Follow-up testing of patients considered high risk for thyroid cancer recurrence and who have unmeasurable basal thyroglobulin (Tg) levels and are deemed to be at significantly increased risk of side-effects/complications from undergoing thyroid hormone withdrawal.

To read the complete statement issued by the FDA to healthcare professionals, go to http://tinyurl.com/2vtp7jn

To read the complete statement issued by Genzyme, go to http://tinyurl.com/365g5bq

Additional Information

Please find additional information regarding recent news related to Thyrogen below:

On May 24, 2010, Genzyme Corporation entered into a Consent Decree of Permanent Injunction with the United States Food and Drug Administration (FDA) that relates to, among other things, the fill/finish manufacturing operations for Thyrogen performed at Genzyme’s Allston, Massachusetts facility. The Consent Decree is subject to approval by the court.
This Consent Decree resulted from ongoing manufacturing issues over which FDA believes it needs additional control. The Consent Decree is designed to permit Genzyme to manufacture Thyrogen in the U.S. to meet the needs of patients for whom Thyrogen is considered medically necessary by FDA. The Consent Decree requires Genzyme to distribute each kit of Thyrogen in the U.S. with a copy of a Dear Healthcare Provider (DHCP) Letter that contains FDA’s criteria for determining the medical necessity of Thyrogen for a given patient, and Genzyme’s distributors must also certify that these DHCP Letters will be included with all Thyrogen kits. The distribution restrictions (requiring certification by customers and distribution with DHCP Letters) apply only in the US market.
Thyrogen is safe for use in the population that FDA has defined for medically necessary use. Genzyme is not permitted at this time to comment on the use of Thyrogen in patients other than those in the population that FDA has defined for medically necessary use. The FDA has not mandated a product recall of Thyrogen.
Genzyme is working as quickly as possible to transfer fill/finish operations for Thyrogen distributed in the U.S. to a contract manufacturer and expects Thyrogen filled/finished at that site to be available no later than November 28, 2010. Once this transfer is effected, the above limitation on the distribution of Thyrogen in the U.S. will be lifted.
If you have any additional questions or need further information, please contact Genzyme Medical Information at 800-745-4447 (option 2) or by e-mail at medinfo@genzyme.com.

Leave a Comment

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..