Articles

THE TAKE ON PHARMACEUTICALS
 
Diabetes Drug Avandia; Consult Your Doctor
 
Richard Harkness, Pharm, CDM, Natural Medicines Specialist
 

Avandia has been at the epicenter of controversy since findings from a recent meta-analysis suggested it might boost the risk of heart attack.
 
Avandia (rosiglitazone) is widely prescribed to control blood sugar in those with type 2 diabetes. Rosiglitazone, combined with another diabetes drug, is also present in Avandaryl and Avandamet.
 
Federal overlords have responded to the media blitz with a typical “Casablanca”-style approach: Round up the usual suspects.
 
Congress called hearings. Experts testified. Lawmakers properly admonished the FDA for not dogging the drug more closely after it was approved and turned loose. Never mind that it is congressional underfunding that keeps the FDA bloodhounds underfed and thinned out.
 
There’s even a bit of cloak-and-dagger. One medical expert told Congress he was harassed by company representatives in 1999 when he first called attention to heart problems in some patients using Avandia. Reportedly, the company’s stock value plummeted billions of dollars in reaction.
 
On to information you can use.
 
Since my prior column, researchers have released partial results from the ongoing clinical trial called RECORD. The data were presented as positive for Avandia, but the results were actually inconclusive in regard to heart attack risk.
 
If the noose continues to tighten around Avandia, clinicians will be wondering whether its sibling Actos (pioglitazone) might also be implicated. Actos seems to have more favorable effects on cholesterol and triglycerides, and some debatable research suggests it might actually help prevent heart attacks.
 
The FDA has scheduled a meeting July 30 with outside experts to wade through the muddle of data.
 
In contrast to the U.S., European product labeling for Avandia carries a caution about possible heart attack risk.
 
The FDA, perhaps feeling pressure to do something, has proposed a “black box” warning on product labeling for both Avandia and Actos. But the warning won’t be about heart attack risk.
 
Instead, it will highlight the risk of congestive heart failure, a caution that is already present in product labeling and well-known to prescribers.
 
Heart failure occurs when the heart is unable to pump blood efficiently. Avandia and Actos can cause fluid retention (edema). This increases the heart’s workload and can lead to new heart failure or worsening of existing heart failure.
 
The tell-tale signs of heart failure include edema (e.g., swelling of feet or ankles), sudden weight gain, or shortness of breath.
 
Another potential danger is drug-induced liver impairment, though this problem appears to be rare with Avandia and Actos. Rezulin (troglitazone), the original drug in this family, was withdrawn from the market in 2000 for this reason.
 
Symptoms of liver damage include unexplained nausea and vomiting, abdominal pain, tiredness, appetite loss, and yellow skin or eyes (jaundice).
 
Alternative drugs for type 2 diabetes include metformin, the sulfonylureas (glimepiride, glipizide, glyburide), and Januvia (sitagliptin), as well as insulin.
 
The American Diabetes Association is now encouraging patients taking Avandia to consult with their doctor to decide whether the benefits outweigh the potential risks.
 

© 2007 Richard Harkness. All rights reserved.

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Richard Harkness is a consultant pharmacist, natural medicines specialist, and author of eight published books.  Write him at 1224 King Henry Drive, Ocean Springs, MS 39564. 

Richard Harkness, Pharm, CDM, Natural Medicines Specialist

Email Richard Harkness at: rharkn@aol.com.