Diabetes Medications, One Old and One New, Run into Trouble

A potential new treatment for type 2 diabetes, dapagliflozin, recently failed to gain approval from the FDA. What makes this rejection noteworthy is that the new medication works by a completely new mechanism causing the kidney to excrete sugar from the blood into the urine. Reasons for the rejection were the increased risk of bladde and breast cancer in those taking the medication, increased urine and genital infections and possible liver toxicity. That list of problems seems pretty convincing to me. This is unfortunate because the drug appears to cause weight loss and does not cause low blood sugar (hypoglycemia). However, a drug that works by “poisoning” the kidney so that it dumps sugar into the urine strikes me as a drug that is going to cause a lot of other problems.

The other established diabetes medication generating new warnings is Actos (pioglitazone). I have written a number of articles on the sister drug Avandia, defending its usefulness despite possible cardiovascular risks, but the cancer warning for Actos is a new angle on this class of drugs (thiazolidinediones). Actos has been withdrawn in France due to concerns that it may cause bladder cancer but no such action has been taken in the U.S. The FDA this month did issue a warning that individuals with bladder cancer or at risk for bladder cancer, should be advised not to use Actos. If Actos is hit hard by these actions this whole class of diabetes drugs will have been eliminated from use.
A sure sign of trouble for Actos is that a “google search” for Actos is now showing lawyer websites as the first 5 citations.

Being sick is dangerous. Treating illness also has dangers. I am concerned that our cultural zeal for uncovering scandals and for pursuing litigation will lead us to sterile treatment options and doctors who are unwilling to risk helping.

Gary Pepper, M.D.
Editor in Chief, metabolism.com

More Toxic Thyroid Supplements

During 2 decades of practicing endocrinology I had not encountered an instance of an over the counter product containing enough active thyroid hormone to make a difference in thyroid levels. In the last month I consulted on two new patients who appear to have developed toxic thyroid levels due to non-prescription products. The first involved a “Metabolic Complex” obtained from New Zealand. This seemed like a fairly random event in which a non-prescribing health practitioner was able to obtain an unregulated product which was passed on to the patient. Not likely to become a common issue. This second instance is more worrisome since it involves a product purchased directly by the patient from the internet, and supposedly “vegetarian” in nature.

Here is the story. A woman with a history of hypothyroidism for about one year taking synthetic prescription thyroid hormone decided to find a more natural solution to thyroid hormone replacement. She stopped the thyroid hormone replacement prescribed by her local physician and purchased a product via the internet advertised to improve thyroid gland “health”. Prior to starting the OTC product her thyroid blood tests indicated low thyroid levels, as expected. About a month after starting the thyroid supplement her thyroid levels were clearly above normal, entering the thyrotoxic range. Fortunately she returned to her physician who alerted her to the problem and asked her to stop the thyroid supplement and one month later she was back to being hypothyroid again. It was at this time I first consulted with her and found her to have the expected symptoms of fatigue, weight gain, poor memory, dry skin and water retention (edema). I restarted her on prescription thyroid hormone replacement.

I wanted to see the product bottle myself but was unable to obtain it. Instead I went on-line and tried to track down the product’s manufacturer and list of ingredients. It was a frustrating exercise since the names of the products and the manufacturers and distributors changed from one website to another. I narrowed my search to one product manufactured in California and another in Canada. Perhaps I will be able to get the original pill container and nail this product down but for now it remains a bit mysterious.

Members of metabolism.com have asked me to pass on the name of these products. Now come on…do you think I want to make this situation worse by giving the information away to juvenile delinquents? I am hoping government regulators will become more vigilante to what appears to be a growing problem. In the mean time I advise everyone to be on the alert to similar products being marketed to an unsuspecting public.

Gary Pepper, M.D.
Editor-in-Chief, Metabolism.com

Some of the details of this report have been changed to protect the identity of my patient. This information is for educational purposes only and is not intended as medical advice or therapy.

Beware the Zombie Thyroid!!

Beware the Zombie Thyroid!!

Periodically, I update metabolism.com with interesting problems from my medical practice. Last week I was reminded of a particular thyroid disease which is little known and deserves more attention. In my patient’s case, she had an inactive thyroid (hypothyroid) due to Hashimoto’s thyroiditis for several years which, on its own switched to become an over-active thyroid (hyperthyroid). I call this event a “Zombie Thyroid”. Don’t bother trying to look this term up since ‘Zombie Thyroid’ is my own terminology. A Zombie Thyroid is, of course, one which returns from the dead. Most times when the thyroid is destroyed by either natural forces or by human intervention, the destruction is complete and irreversible. Rarely however, a thyroid which ceased function for years resumes producing thyroid hormone and may even becoming “hyper” or over-functioning. Such was the case of my patient last week. Confusion may result because the newly risen thyroid begins adding thyroid hormone to the blood of someone already taking thyroid hormone replacement for hypothyroidism (under-functioning thyroid). Recognizing the Zombie Thyroid can take months or years due to the rarity of the condition and the subtlety of the changes that occur on blood testing.

The Zombie Thyroid occurs in the setting of either autoimmune thyroid disease such as Hashimoto’s thyroiditis or a structural thyroid disease, multinodular goiter. Hashimoto’s is the most common cause of naturally occurring hypothyroidism in women under the age of 60 years. Hashimoto’s occurs when the body creates an antibody to the thyroid, resulting in destruction or impairment of the thyroid tissue. It is thought that the thyroid can ‘return from the dead’ if the body begins to produce more of another type of antibody that results in stimulation of the thyroid tissue. The switch from under active to over-active can take months or years. During this time the combination of taking thyroid hormone pills for Hashimoto’s plus the new supply of the body’s own thyroid hormone production can result in disturbing and seemingly unexplainable high thyroid levels. Once it is clear that the thyroid is producing thyroid hormone again it is possible to make appropriate adjustments in medication to return the situation back to normal.

Another situation involving the Zombie Thyroid is seen in elderly people who have had an enlarged and lumpy (nodular) thyroid for years. Some of these “multinodular goiters” produce adequate amounts of thyroid hormone but others can be associated with thyroid hormone deficiency (hypothyroid). When the multinodular goiter causes hypothyroidism, the patient will be treated with thyroid hormone replacement just like the Hashimoto’s patient. Over time the nodules may slowly begin to wake up and begin producing thyroid hormone. If the patient is already taking thyroid hormone due to the previous diagnosis of hypothyroidism, the combination of the two sources of thyroid hormone can result in excess or “hyper” thyroidism. In the elderly the doctor may suspect the elevated thyroid hormone levels are the result of a medication error perhaps due to the patient’s forgetfulness. If no action is taken serious complications of hyperthyroidism can develop such as irregular heart beat, congestive heart failure, excessive fatigue, and mental or mood impairment. Some elderly patients become withdrawn and lose weight mimicking depression, a situation known as “apathetic hyperthyroidism”. Recognition of the Zombie Thyroid is essential to restoring the thyroid levels and the patient’s clinical status back to normal.

Don’t let yourself or loved one become a victim of this ‘back from the dead’ thyroid. Alertness is the key to recognizing and treating the Zombie Thyroid. Ask your own physician for advice if you suspect this condition.

This article is for educational purposes only and is not meant as medical advice. The disclaimer of metabolism.com applies to this and all my blogs.

Gary Pepper, M.D., Editor-in-Chief, metabolism.com

Dr. Oz, What Exactly Don’t You Know?

For a relatively small South Florida town, Jupiter has attracted a few national news stories. Recently there was the disturbed man who gunned down 4 members of his own family, and Tiger Woods is building his mother a house here. Bringing Dr. Oz to Jupiter is the recently confirmed pediatric brain tumor cluster just West of here. This has stirred up a lot of media attention and later this week Dr. Oz is doing a special on the cancer cluster.

What type of doctor is Dr. Oz? He is a heart surgeon. His training is in using a knife to cut the chest open and in sewing arteries together to heal the diseased heart. Why is he talking to the nation about a brain cancer cluster in South Florida? Why does he have a show where he lectures on everything from swine flu to diarrhea? This situation reminds me of a soap opera where the show’s doctor delivers a baby, removes someone’s brain cancer, and treats someone else for AIDS, all in the same episode. Sorry folks….that’s not the way the real world of medicine works.

O.K…so call me jealous. That doesn’t change the fact that our nation deserves real experts dealing out the facts, not some handsome Oprah pet doc pretending to be G-d’s gift to the medical world.

Operating on the heart requires constant practice and intense focus on only what lies underneath that knife. It shouldn’t come as a surprise therefore, that the last cardiac surgeon I would want operating on my heart is Dr. Oz.

Dr. Gary Pepper, Editor-in-Chief, Metabolism.com

Marion Touts New Adkins Diet for Weight Loss for Ex-Smokers

Marion brings us up to date on her progress after stopping smoking, gaining and then losing weight. Thank you Marion for sharing your experience with metabolism.com members!

Marion writes:

Just wanted to give you an update, quit smoking 8 months ago and have gained exactly 20 pounds, seems like the weight gain has finally slacked off. Last Monday a week ago I started Atkins, lost 9 lbs in 7 days, must be alot of fluid. Just the effects of being on Atkins, I feel so much better, but the best part is it forcing your body to burn fat and increases your metabolism. Try it its not as hard as you think. The NEW Atkins is alot more flexible and easy to learn than the old version. Basically the same with a few easier ways of understanding it. Good Luch I hope it works. Thanks, my goal is to wear a bikini this summer, not in public of course just at home in my pool, lol.

LA Falls Through a Crack in Our Health Care System and Finds Armour Shortage Crisis

LA lives in rural America and has no health insurance. After 30 years of effective therapy with Armour Thyroid she is unable to obtain this medication any longer. Her story is a sad reminder of just how far we need to go to provide meaningful health care to the citizens of this country.

LA tells her story like it is:

I knew nothing about this problem of non-availability of Armour Thyroid. I have been on Armour since 1978 and it has worked just fine. I had my annual prescription renewal in June and because I do not have insurance, I was able to get 200 pills at a time for a price break. I take 3 60 mg tablets a day and have been on this dosage for about 6 years, up from a previous dosage of 2 60 mg tablets. Today, 4 Nov 09, I went to pick up a refill that I called in a week ago. I was informed at the pharmacy that Armour Thyroid is no longer being made. Period. I took my last pills on 2 November so I have no medication at all. I have a call in to my doctor but he has not yet returned that call. We contemplated a switch to Synthroid a couple of years ago (for a variety of reasons, none of which are relevant here) but the doctor said it could be a very slow process of finding out exactly what dosage of synthetic hormone would adequately replace the natural Armour. At that time I had insurance that would have covered the lab tests required to determine the proper dosage. I am now without insurance due to the death of my spouse, and because of the hypothyroidism I am unable to obtain health insurance that is even remotely affordable. Therefore I can’t afford all the tests, all the doctor visits, all the rest of the hoopla that woudl go with switching medication. I’ve been fortunate so far that I’ve been able to keep my same doctor, and that he gives me a bit of a break paying cash for my once-a-year-visit, but he’s 60 miles away and I can’t even afford the trips back and forth if I have to start “nudging” a new medication. It’s bad enough to be without the medication for a while, but to think that it will never be available again? I honestly don’t know what to do.

I knew nothing about this problem of non-availability of Armour Thyroid. I have been on Armour since 1978 and it has worked just fine. I had my annual prescription renewal in June and because I do not have insurance, I was able to get 200 pills at a time for a price break. I take 3 60 mg tablets a day and have been on this dosage for about 6 years, up from a previous dosage of 2 60 mg tablets. Today, 4 Nov 09, I went to pick up a refill that I called in a week ago. I was informed at the pharmacy that Armour Thyroid is no longer being made. Period. I took my last pills on 2 November so I have no medication at all. I have a call in to my doctor but he has not yet returned that call. We contemplated a switch to Synthroid a couple of years ago (for a variety of reasons, none of which are relevant here) but the doctor said it could be a very slow process of finding out exactly what dosage of synthetic hormone would adequately replace the natural Armour. At that time I had insurance that would have covered the lab tests required to determine the proper dosage. I am now without insurance due to the death of my spouse, and because of the hypothyroidism I am unable to obtain health insurance that is even remotely affordable. Therefore I can’t afford all the tests, all the doctor visits, all the rest of the hoopla that woudl go with switching medication. I’ve been fortunate so far that I’ve been able to keep my same doctor, and that he gives me a bit of a break paying cash for my once-a-year-visit, but he’s 60 miles away and I can’t even afford the trips back and forth if I have to start “nudging” a new medication. It’s bad enough to be without the medication for a while, but to think that it will never be available again? I honestly don’t know what to do.
LAWHilton@yahoo.com
LA
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