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Doctors' Answers to "Frequently Asked Questions" - Rezulin

These comments are made for the purpose of discussion and should NOT be used as recommendations for or against therapies or other treatments. An individual patient is always advised to consult their own physician.

[posted 03/29/2000]
Question: 66 yr old diabetic and have been takin Rezulin for two yrs.
6 mos after starting Rezulin I developed bleeding in the perineum area.Family Dr. referred me to gen. surgeon who performed surgery but could not find source of blood. He sent me to a wound center and a vascular surgeon who sent me to a plastc surgeon who performed another operation to correct the problem. After over a year the blood discharge still existed.On 3/14/00 I discontinued the use of Rezulin and within two days the bleeding literally stopped and since
then only minor indications of the problem still exists. I beleive that the Rezulin was the cause of my problem but can
not find any medical source that confirms the cause/result and probable cure or stopping at this point.Your comments on this would be greatly appreciated. Roger Curley

Answer: I haven't seen this, but certainly sounds associated. Rezulin is off the market now in any case.

[posted 03/23/2000]
Question: my father had been on coumadin for years but after getting on rezulin he became sick and was takin to the hospital with a protine count of 142 and bleeding thru the skin. i believe it was caused by the rezulin effecting the liver. what is your opinion?

Answer: Hard to know, but the drug is off the market for this reason. Get a copy of his liver functions before, during and after the rezulin. This will answer your problem.

[posted 02/4/2000]
Question: in your opinion can liver cancer be caused by meds namely Rezulin, no other liver desease at all

Answer: Probaby not, but a fairly new drug without a long history.

Rezulin [posted 1/11/99]
Question: My husband has been taking Rezulin for 6 months. He has developed an altered sensation in his toes and fingers. Two physicians say his blood sugars are normal, he hasn't had high blood sugars in the past, and it is unlikely to be diabetic neuropathy. A podiatrist thinks it is. Could this altered sensation be due to the Rezulin.

Answer: Probably not, but easy to stop and see what happens. I would get an EMG and see what the cause is.

Rezulin [posted 1/5/99]
Question:Can you give me any new feedback about the side effects of Rezulin? Any new deaths by people on Rezulin, or any continued liver problems?

Answer:I'm not aware of any deaths. There were a few cases of elevated liver enzymes, which prompted the company to recommend regular liver function tests while using the drug. However, in my practice I have not seen any problems with the 50 or so patients I have taking the drug.

Rezulin & Ovulation  [posted 11/24/98]
Question: I recently started taking this drug for type II diabetes. After reading the side effects portion of the medication, I noticed that it has been noted to start ovulation. I also have polycystic ovarian syndrome, so this would be a blessing to me. Is there any other information out there about this so called side affect, and if it increases your chances of getting pregnant...or multiple birthes? I can't seem to find anything written about this. 

Answer:  I don't have information here, but check with Parke-Davis 800-223-0432. 

Rezulin & Fertility [posted 11/19/98]
Question: I took Rezulin for almost a year. I do not have diabetes, but have insulin resistance. I had good results with the drug. I stopped taking the drug before trying to get pregnant. After 6 mos. no luck. My endocrinologist wants me to go back on the Rezulin in order to get pregnant. What is known at this point about the affectiveness of Rezulin in aiding getting pregnant and it's possible affects on a baby? Also, if I do not have diabetes, should I still be concerned about the recent reports of possible liver damage? Thank you for your response.

Answer: No usual problems if you watch regular liver functions. As to the pregnancy issue, can't help';but, I'm getting a lot of questions about this issue.

Concerns About Using Rezulin & Heart Medication [posted 11/5/98]
Question: My 78 yr old mother is a complex patient with Diabetes, CHF, hypertension and pulmonary problems. She has been on insulin for ten years and started Rezulin at the end of last year. It works well for her but I am wondering if there are contraindications to take it with her congestive heart failure which is requiring aggressive treatment. Please advise...thank you.

Answer: Shouldn't be.

Questions about Rezulin [posted 10/23/98]
Question: My father is a type 2 diabetic, taking three insulin shots a day. Would Rezulin be beneficial to him and help him lessen the frequency of his shots and/or lessen the amount of insulin that he must inject? Please send me any information of Rezulin (not questions and answers if possible) that might help us determine the decision on this medicine.

Answer: Rezulin increases the efficiency of insulin, either that given as shots or endogenous insulin(like a type 2). Side effects are pretty minimal, mainly gi and there must be ongoing monitoring of the liver functions. Usually well tolerated without major problems in my patients.

Rezulin & Liver Function Concerns for Diabetic, Hypertensive Patient [posted 10/21/98]
Question: A type II diabetic taking nPh (5 units short 1 x day/ 15 units 2 x day)because he can not tolerate Humulin. About 30 Lbs over weight. Exercises aerobic 2-3 x weekly 20 min per time. Has had higher than normal liver tests however, he recently had prostate cancer which is thought to have been a contributing factor to the liver results. Had radical prostatectomy and levels are near normal. Has hypertension. Minipress and Maxide Rx.

1. How can Rezulin be of assistance if it's primary function is to reverse insulin resistance?
2. Is he at greater risk of liver "problems" if he takes Rezulin?
3. How does Rezulin interact with the above hypertension Rx?

I recently read the Wallstreet Journal advertisement by Parke-Davis which raises the above issues. From speaking with generalist MD and from researching the internet, it appears that very little is known about the efficacy of this drug and its long-term effects. Would it be better to speak with an endocrinologist specializing in diabetes? Or would you suggest some other specialist?

Thank you for your assitance with this matter and for your prompt response. I do understand that your answer is merely a recommendation and that it is difficult to advise without actually seeing the patient and/or reviewing the medical history of a patient.

Answer: Rezulin is a relative newer drug for treating diabetes mellitus. It is thought to work by increasing the efficiency of insulin and thus useful in both Type I and Type II. There is thought that high insulin levels actually accelerate cardiovascular disease and lower levels might help avoid long term complications. He should be ok vis a vis the liver as long as his liver function tests are followed closely(necessary on Rezulin anyway). But, he is probably at some higher risk due to the previous problem(unlikely due to his prostate by the way). There should be no obvious interaction with the bp drugs.

Rezulin Side Effect? [posted 7/21/98]
Question: I am taking rezulin and have developed a sore on the bottom of my tongue. It is extremely painful. I am also on prozac and lotensin.
Rezulin.....600 mg
Lotensin.....10 mg
Prozac........20 mg
Could any of these cause this reaction?

Answer: Rezulin is pretty new and this hasn't been one of the problems that I've seen with the drug. But, I only have about 8 months experience and about 20 patients or so on the drug. Stop it for 3-4 weeks and see if the ulcers resolve. Then restart the Rezulin and see if they reoccur. If so, it is the drug and needs to be reported as an adverse drug reaction to the FDA.

Question: My husband took rezulin for 3-6 months and has had blood tests every 3 months. The 6th month test results show liver enzymes tests 9 times higher than normal. He had a biop. done 2 years prior and was normal. He is off rezulin, but the results are not significantly lowered yet.

Answer: Give it two months or longer. Also, there are many potential reasons for this. Has he been checked for hepatitis?

Question: Is the drug Rezulin expected to be useful? Who will it be indicated for? Are there any major side effects? Will it effect fat deposition or increase obesity in patients?

Answer: Rezulin is a new concept in treating Diabetes Mellitus. Although the exact mechanism is still being researched, this drug appears to change the receptor sites affinity and possibly the number of insulin receptor sites. Most Type II or Adult Diabetics do make insulin. However, their body cannot make efficient use of the insulin available leading to high sugars and diabetes. This drug will be a major breakthrough in increasing the ability of insulin to enter and be utilized in the cell.

Blood Sugar Levels
Question: I have been taking rezulin for 2 weeks. The first 10 days my blood sugar levels were much higher than usual. However, on the 13th day they finally dropped. I feel much better. I have more energy and am not hungry all the time. Is this a normal reaction to the drug?

Answer: Yes.

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