Tag Archives: rosiglitazone

FDA Reversal: Rosiglitazone DOES NOT Pose Cardiovascular Risk

Rosiglitazone is a type 2 diabetes drug in the thiazolidinedione class. In 2011, the U.S. Food and Drug Administration determined that rosiglitzone posed a substantial risk for causing premature cardiovascular disease such as heart attacks. The agency greatly restricted prescribers, essentially killing the drug’s sales in the U.S. In November, the FDA took another look at the data and decided the risk was minimal or non-existent.

Dr. Steven Nissen of the Cleveland Clinic is on record as opposing the new change.

A lot of personal injury lawyers will be disappointed in the change unless they’ve already settled their cases out of court.

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FDA Advisory Panel to Look at Rosiglitazone Once Again

Larry Husten writing at Forbes has the details. For example:

Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated.

 

But at least one source of fierce criticism won’t be participating in the panel. Steve Nissen, who originally raised concerns about the drug and who has remained the most consistent critic of the drug, will not participate in the deliberations or present to the committee. Early on Thursday Nissen contributed a blog post on Forbes accusing the FDA of stacking the committee in favor of rosiglitazone. The FDA leadership, he says, is trying to use the meeting to “whitewash” its reputation…

Are they considering lifting the heavy restrictions on the drug? I see very few rosiglitazone users these days.

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Trouble Seeing? Might Be Your Diabetes Drug

Macular edema is two to five times more common in type 2 diabetics taking pioglitazone or rosiglitazone, according to an article published June 11, 2012, by MedPage Today.  The original research was reported in Archives of Internal Medicine.

The macula is the dark area in the middle of the right half of this retina photo

The macula is the most sensitive part of the retina at the back of your eyeball.  Edema, or watery swelling, of the macula can impair vision.

Very few patients in the U.S. use rosiglitazone any longer because of concerns about heart toxicity.  Pioglitazone has recently been implicated as a cause of bladder cancer.

You can avoid some diabetes drug complications by controlling blood sugars with diet and exercise.

Steve Parker, M.D. 

Reference:
Idris I, et al “Association between thiazolidinedione treatment and risk of macular edema among patients with type 2 diabetes” Arch Intern Med 2012; DOI:10.1001/archinternmed.2012.1938.

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R.I.P., Rosiglitazone

Rosiglitazone is pretty much dead.  Here’s the eulogy at the FDA website.  Rare is the doctor who will jump through all the paperwork hoops when we have 10 other classes of drugs to treat diabetes, plus another, safer drug in the thiazolidinedione class.

Rosiglitazone is linked to higher rates of heart disease and death.

Steve Parker, M.D.

 

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Rosiglitazone Severely Restricted by FDA

MedPageToday reported yesterday on the U.S. Food & Drug Administration’s ruling that the diabetes drug rosiglitazone should be used in new patients only if blood sugars are not controlled with other diabetes drugs, such as pioglitazone.

It sounds as if new users and their doctors may have to jump through some paperwork hoops to get the drug, which is more reason not to prescribe it.

The problem is that scientific studies suggest that rosiglitazone increases the risk of heart attack, heart failure, and death.

Steve Parker, M.D.

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Rosiglitazone On the Ropes

A week ago, MedPageToday reported that a British advisory commission recommended the diabetes drug rosiglitazone (Avandia) be withdrawn from the market.

On July 6, I wrote about evidence that rosiglitazone users seem to incur a higher risk of stroke, heart failure, and death.

If I were taking Avandia, I’d be asking my doctor about alternatives. 

Steve Parker, M.D.

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Diabetes Drug Rosiglitazone About to Be Pulled Off the Market?

ResearchBlogging.orgIt’s over for rosiglitazone.

Sold in the U.S. as Avandia, rosiglitazone is a drug used to control type 2 diabetes either alone or in combination with insulin, metformin, or a sulfonylurea.  It has only one competitor in its class: pioglitazone (sold as Actos).

Both drugs in the thiazolidinedione class (aka TZDs or glitazones) increase the risk of heart failure.  Prior studies had suggested that rosiglitazone increases the risk of heart attack, heart failure, and death.  Research suggested that pioglitazone actually reduces the risk of heart attack, stroke, and death.

A study just published in the Journal of the American Medical Association directly compared clinical use of rosiglitazone and pioglitazone.  Investigators looked at Medicare data involving over 227,000 patients, average age 74, average follow-up of 105 days.

Rosiglitazone comes out the loser: users had significantly higher risk of stroke, heart failure, and death.  Risk of heart attack trended a bit higher in the rosi users but did not reach statistical significance. 

The researchers also calculated the composite risk of suffering either a heart attack, stroke, heart failure, or death:  rosiglitazone risk was about 18% higher compared to pioglitazone. 

What do these numbers mean from a practical viewpoint?  The researchers calculated a “number needed to harm.” Treat 60 patients with rosi and 60 with pio for one year; the rosi group will have one extra event—heart attack, stroke, heart failure, or death—compared with the pio users.

Why put up with that risk?  There’s no good reason.  Especially when pioglitazone is available.

Implications

If you take rosiglitazone, ask your doctor to find an alternative or switch you to pioglitazone.  Soon.

Clearly, we don’t know all of the adverse effects of many of the drugs doctors prescribe, whether for diabetes or other illnesses.  We balance the good with the bad, and that equation changes over time. 

Rosiglitazone’s manufacturer may pull the drug off the market voluntarily.  If not, the FDA will do it.  Cardiovascular disease—e.g., heart attacks, strokes, heart failure—kills 68% of diabetics.  The last thing we need is a drug that increases that risk.

Within a month, you’ll see ads on U.S. television from trial lawyers asking if you or a loved one has been hurt by rosiglitazone.  “If so, call this toll-free number now…”

Steve Parker, M.D.

Reference: Graham, D., Ouellet-Hellstrom, R., MaCurdy, T., Ali, F., Sholley, C., Worrall, C., & Kelman, J. (2010). Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone JAMA: The Journal of the American Medical Association DOI: 10.1001/jama.2010.920

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