Posted on May 25, 2011 by Joel Shpigel R.Ph.

Diabetes Drug Avandia FINALLY Will Be Removed From Pharmacy Shelves

Pharmacies soon will no longer be able to stock the Diabetes drug Avandia.

After November 18th, only certified doctors will be able to  prescribe the drug and only patients who know the risks and are willing to fill their prescription through the mail from specific pharmacies may receive the drug, USA Today reported. In case you were not aware, FDA drug-safety expert David Graham told an advisory committee in 2007 that Avandia had caused heart problems, including deaths, in 66,000 to 200,000 people.

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Posted on November 12, 2010 by Joel Shpigel R.Ph.

The Good, The Bad and The Ugly of Diabetes 2010

 

 

 

Because  this month is National Diabetes Month and this Sunday, November 14th is World Diabetes Day, NOW is a good time to think about the current "state of affairs: concerning what is probably the biggest health issue in this country: Diabetes.

Here's the Good:

  • In the lab of Dr. Pere Santamaria at the University of Calgary,  researchers developed a vaccine that successfully reversed insulin dependent diabetes in mice. Most importantly,  only those immune cells that were responsible for destroying the insulin-producing beta cells in the pancreas.were targeted by the vaccine. Hopefully, we will see testing done on humans in the near future..

  • Although it is probably years away from market, the first closed loop artificial pancreas system was officially tested with positive results.

  • Pedro Herrera, at the University of Geneva Medical School, and his team found that the adult pancreas can actually regenerate alpha cells into functioning beta cells. Other researchers have been able to "reprogram" other cells in the body into beta cells,

Here's The Bad:

  • In September 2010, the U.S. Food and Drug Administration (FDA) announced that it would be severely restricting the use of  the type 2 diabetes medication Avandia, due to the risk of "cardiovascular events" such as heart attacks and strokes. The only patients who would be permitted to get it were those who could not tolerate any other diabetes medication or those who were experiencing great results without side effects.

Here's The Ugly:

  • In the past week,  U.S. Centers for Disease Control and Prevention announced that if America stays on its current path, one in three Americans will have diabetes by 2050. The number of people diagnosed with diabetes annually is predicted to jump from its current  8 per 1,000 people to 15 per 1,000 by 2050, according to CDC estimates. According to the American Diabetes Association, the effects of weight loss look as good as the results would for a drug that would end up getting approved. And, if you lose as little as five to seven percent of your weight, you will probably see a positive difference.
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Posted on September 23, 2010 by Joel Shpigel R.Ph.

Diabetes Drug Avandia Now Under Harsher FDA Restrictions

 

New FDA mandates will make it far more difficult for doctors to prescribe the diabetes drug Avandia. Although the European Medicines Agency has suspended European sales of Avandia-containing drugs, the FDA has NOT banned Avandia in the United States. Regulators say the heart attack risks associated with the drug are ju great a safety concern

 Avandia will be available to new patients only if they cannot achieve [blood sugar] control on other agents and cannot take Actos," FDA commissioner Margaret A. Hamburg, MD, said at a news conference. "Current patients can continue taking Avandia only if they benefit and understand the risks."

Avandia maker GlaxoSmithKline will be required to establish a Risk Evaluation and Mitigation Strategy (REMS) program. Patients, their doctors, and their pharmacists will have to enroll in the program in order to receive, prescribe, or sell Avandia.

In a statement, GlaxoSmithKline says it "continues to believe that Avandia is an important treatment for patients with type 2 diabetes," but that it will work with the FDA and the European Medicines Agency to implement their decisions.

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Posted on April 28, 2008 by Joel Shpigel R.Ph.

New Adverse Effects from Diabetes Drugs Actos and Avandia

As seen in U.S News and World Report, compared to controls, individuals taking Avandia or Actos had more than double the risk of fractures, with the risk with Actos being slightly higher than with Avandia. Drug-associated fractures were particularly common at the wrist and hip. Both men and women were at risk, and the odds for fracture tended to rise with dose of drug taken.

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