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There is a recent report that 257 patients have died after receiving intense therapy to lower their blood sugar. As a result,  the National Institutes of Health has discontinued a portion of major study on diabetes and heart disease. The study was aimed at reducing to normal levels the blood sugar of type 2 diabetics at especially high risk of heart attack and stroke.

It is important to note that NHLBI officials stressed that they have been unable to link the increased deaths in the study to any drug, including Avandia. There are over 18 million Americans that have been diagnosed as having diabetes, with type 2 the most common form.

Click here to read more from the Associated Press and MSNBC on the recent deaths from dug intense therapy to lower blood sugar.

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This week, The House of Representatives approved legislation that gives the FDA more power to police the safety of prescription drugs, sending the measure to the Senate for final approval.

What if the the Food and Drug Administration required drugmakers to study the safety of their products after they go on the market? Would that be so terrible? Would it be a bad thing for regulators to order warnings added to prescribing information? If these measures can help save lives and prevent more illnesses, I think not.

This new legislation may be able to prevent future repeats of what happened with Vioxx, the Merck & Co. painkiller, allegedly linked to heart attacks and strokes, and Avandia, GlaxoSmithKline Plc's diabetes pill linked in some studies to a risk of heart attacks.

I hope that  Representative Henry Waxman, a California Democrat, is correct in his assessment that the legislation ``provides FDA with critical tools the agency has been desperately lacking in its efforts to protect the American public from unsafe drugs". Now let's see if the Senate agrees.

Click here to read more on this new FDA legislation from Bloomberg News.

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This week there were two major articles discussing the safety of  AstraZeneca's Prilosec and Nexium, one in Forbes written by Matthew Harper, "Averting another Avandia" and on the Star-Ledger of New Jersey's Pharmalot.com written by Ed Silverman, " Will Nexium become the new Avandia"?  

The articles were discussing the newly released public notice from the FDA on the "Early Communication About an Ongoing Safety Review Omeprazole (Prilosec) and Esomeprazole (Nexium)"

In the FDA public notice there is an alarming statement as to increased heart attacks and heart failure. An excerpt from the FDA public notice states "The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery."

However, on the other hand,  Paul Seligman, an associate director in the FDA’s Center for Drug Evaluation and Research, tells reporters “It’s hard to know how this process will play out” and that “this is something of a moving target." This public notice was released to make the pubic aware the FDA is looking into this and will have results from more tests in about three months.

Should the public be alarmed? Is the FDA trying to prevent another Avandia? Time will tell.

On a positive note, it is good that the FDA released this public information rather than an independent source.  The FDA communicated this new information in a somewhat timely manner. On May 29, 2007, AstraZeneca, the manufacturer of Prilosec and Nexium sent FDA  their preliminary review of new data from two studies about the potential heart risks. Since that time, the FDA has been going over the data.

FDA "thank you" for making a bold step in sharing this information about Nexium and Prilosec to the public. We remain hopeful that you will honor your obligations to the public and find out if these two drugs are safe for the public or are they detrimental to increasing a patient's heart risks.

Let's all hope that Neium and Prilosec do not become the new Avandia.

Click Here to read more on Prilosec or Nexium from Forbes and from the  Star-Ledger of New Jersey's Pharmalot.com.

 

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The Executives at GlaxoSmithKline  must be breathing a huge sigh of relief. They only received a mere minor setback with the new Food and Drug Administration decision. Yesterday, The FDA  advisory panels called  for new warnings for the widely used diabetes drug Avandia. New evidence has shown that it significantly raises the risk of heart attack, however, they stopped short of recommending that the drug be pulled from the market, as some FDA officials had urged. I wonder why and how they managed to get a 22 to 1 vote to allow continued sales of  Avandia?

There has been controversy among regulators, drug company officials, physicians and advocates for patients, who have offered dueling interpretations of contradictory safety studies. Maybe it is because it is a "Billion Dollar Baby" for the North Carolina Drug Maker, GlaxoSmithKline. Last year, Avandia produced $3 billion in sales for the company. Today, stock for GlaxoSmithKline closed at $51.08, an increase of $1.64 per share. I think that shareholders must be happy with the news of the new FDA warning.

                                           
The company that produces Tums and other well known brands have been given another chance to make a difference in the lives of millions of people around the world. Let's hope that this miracle they received, will keep them in check and make them proactively share critical information to unsuspecting consumers before they take a GSK drug or product, instead of after the fact. Good corporate citizenship requires as much, if not more.Click Here to read more from the Washington Post on the Avandia FDA Warning.

The LaBovick Injury Law Blog is presented as a service of the Private Law Firm, LaBovick & LaBovick, P.A., Civil Justice Prosecutors. 

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Avandia, a popular diabetes drug, has just been dealt another strike. A new report from the FDA on Wednesday, finds that  patients who take Avandia, face an increased risk of heart attacks over those who take Actos, a similar drug.  According to a recent New York Times article, one review in the study included the following statement: "Patients with heart disease and those taking insulin should not take Avandia". 

Avandia increases the risks of heart attacks by as much as 40 percent in most diabetes patients. In those taking insulin or nitrates, the risks are higher, according to the drug agency’s analysis.  Most diabetics die of heart disease. This news is unsettling, given that the drug was created to save lives, not help cause greater risks.

The FDA is stepping up and diligently trying to ensure the safety of Avandia patients. After the harsh but necessary criticism from Iowa Republican Senator  Charles E. Grassley. Mr. Grassley said. “If F.D.A. leaders are asleep at the switch, it’s a dereliction of duty. But if they’re knowingly suppressing information about risks to public safety, then it’s morally corrupt.” We need more lawmakers to stand up and hold agencies in charge with protecting the public accountable. This should be a bi-partisan issue. It affects everyone.

Unfortunately, this news does not bode well for the drug maker, Glaxo Smith Kline, since the drug is billion dollar producer for the company. Last year Avandia had sales over $3.4 billion. Upon news of this new report, the shares of stock fell $1.40, closing at $51.23.  I am sure the company executives and shareholders are nervous. If the full report that comes out on Monday, and shows more risks for Avandia patients, the drug could be in more danger.  All eyes are on Avandia and the FDA report that comes out on Monday. Should GSK be nervous?  Is there really a reason for this alarm?  Time will tell if GSK will hit a base hit or a sacrificed fly and score a run with this billion dollar drug? I don't really see how they can hit a home run with this one. The other side seems to have scored a few good runs, with these new findings.  Time will tell... Stay tuned....

Click Here to read more on Avandia from the New York Times article

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The widow and son of a Beaumont man are suing the maker of the popular diabetes drug Avandia, GlaxoSmithKline PLC, challenging it contributed to the man's death from a heart attack.

Larry Alan Stanford, 60, died in May, which was around the same time a scientific analysis was published in the New England Journal of Medicine saying that Avandia was linked to a greater risk of heart.

The deceased victim had taken Avandamet, a form of Avandia mixed with another diabetes drug, since early 2005.

Click Here to read more about the case in a recent AP article.

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