Diabetes Medicine Talk

GlaxoSmithKline (GSK) is working on a new diabetes drug that would assist patients in controlling blood sugar.  So far, in clinical trials this drug is proving to be at least as good as most of the drugs on the market, but cannot beat Takeda’s Actos.

Whether or not GSK’s new drug can perform better than Actos might not matter if GSK can prove they are a safer option.  Actos was recently recalled in India due to safety concerns.  Two years ago, the United States Food and Drug Administration (FDA) issued an announcement informing the public about the potential risks between Actos and Bladder Cancer.

Over 3,000 Actos lawsuits are pending against manufacturer Takeda Pharmaceuticals alleging failure to warn.

Right now, GSK’s study is showing that patients taking their drug suffer more gastrointestinal problems compared to patients who are taking Actos or Januvia.  Like Actos, Januvia has also been under scrutiny for a potential increased risk of Cancer.  Rather than causing bladder cancer, studies have suggested that patients who take Byetta or Januvia may have an increased risk for developing pancreatic cancer.

While it may seem that all GSK would have to do to beat out other popular diabetes drugs is not increase the risk for cancer, analysts are still skeptical as to whether or not this drug will have what it takes to be a contender.   Performance and Safety concerns still hang in the balance while competitors Eli Lily and Sanofi are also seeking approval for their own diabetes drugs.

What do you think?  Are you anxious to see new drugs on the market?  Are you concerned about the safety and effectiveness after the recent links between diabetic drugs and cancer?

Earlier this week, the Food and Drug Administration (FDA) sent warning letters to 15 companies advising that the sale of their illegally marketed diabetes products are in violation of federal laws.

These medications are over the counter drugs and remedies that claim to mitigate, treat, cure or even prevent diabetes.  Some of these manufacturers are recommending that these products be used in place of a patients prescribed diabetes treatment.  Taking this advise could lead to a serious medical emergency.  Diabetics rely on their medical to keep their glucose levels stable.    Patients treating for diabetes, or any other medical condition should never discontinue their prescribed treatment without speaking with their doctor. You should also consult with your doctor before trying any new over-the-counter remedies to make sure they are in fact safe.

These illegally sold Diabetes medications include:

“Natural” diabetes treatments- Many of these contain undeclared active pharmaceutical ingredients that could cause harm to those with other medical conditions.

Eastern Remedies- Medications from India claim to treat, cure and prevent diabetes.  Most of these are sold as dietary supplements.

Unapproved homeopathic over-the-counter (OTC) products- These are targeted towards patients experiencing symptoms of nerve damage or peripheral neuropathy.

Prescription drugs sold online without a prescription.

So far, the FDA is not aware of any injury or illness associated with these illegal products, but the agency is giving the manufacturers 15 days to provide a written response on how they plan to rectify the situation.  At the same time, the FDA is advising consumers not to use these or any similar products, because they may be unsafe.  A list of the affected products can be found here.

If you have taken any of these products, please consult your doctor to make sure that you have not experienced any negative side effects.

One June 12th, Healthcare Giant Merck announced its support for the American Diabetes Association’s (ADA) call for an independent safety review on a number of diabetes treatments which included Merck’s Januvia.

The study is focusing on a class of Type 2 diabetes treatments that make up a class of drugs known as incretin mimetics.  Merck will be providing a data analysis and safety profile from Januvia clinical trials to be reviewed by the National Institute of Diabetes and Digestive/Kidney Disease and the National Cancer.  The data will be used as part of a study on pancreatitis, diabetes and pancreatic cancer.

Two more pharmaceutical corporations, AstraZeneca and Bristol-Myers Squibb issued a joint statement advising that they will also support the study.  AstraZeneca and Bristol-Myers Squibb manufacture two popular injectable incretin mimetic diabetes drugs — Onglyza and Byetta.  Victoza, manufactured by the Diabetes specialists, Novo Nordisk is also included in the study.

The purpose of this study is to examine the link between this class of diabetes drugs and pancreatic cancer.   These drugs, mostly Byetta and Januvia have been hot controversial topics since talk of unpublished findings in the medical community linking Byetta and Januvia with an increased risk of pancreatic cancer began this past March.

However, according to Bloomberg News, the documents that were handed out on the June 12th session indicated that some FDA scientists felt that the findings did not support the hypothesis of a significant link between Byetta, Januvia and other increntin mimetics and an increased risk of pancreatic cancer.  While the scientists believe that additional data mining is unlikely to show more evidence, patients across the country have been filing Byetta lawsuits and Januvia lawsuits after taking these drugs and receiving a diagnosis of pancreatic cancer.

Even with more than 10,000 Avandia lawsuits pending, panelists at a Food and Drug Administration (FDA) hearing supported GlaxoSmithKline’s (GSK) request to loosen the restrictions on the controversial diabetes medication.

Restrictions were placed on Avandia in 2010 after the FDA reviewed a 2007 study produced by the Cleveland Clinic that suggested the presence of a link between Avandia and heart failure.  According to the study, patients that took Avandia had a 43 percent increased risk for suffering a heart attack compared to diabetes patients that took a rival medication.

Throughout the controversy, GSK maintained that the study was flawed and that the risks associated with Avandia have been overstated.

Surprisingly, there was no television coverage about the hearing that was held during the first week of June.  Avandia was GSK’s blockbuster drug until the restrictions were placed and the lawsuits were filed.    Now there are only a few thousand people who use Avandia to treat diabetes.  However, this may change if the restrictions are lifted.

Half of the 26 FDA panelists voted in favor of losing or removing the restrictions that the FDA placed on Avandia in 2010.  While GSK views the panel’s willingness to loosen Avandia restrictions as a small victory, the FDA will have the ultimate say in the future of Avandia.

According to the National Confectioners Association, July 7th is National Chocolate Day.  Just because you’re watching your sugar level doesn’t mean that you have to miss out on observing this totally sweet holiday!

I love any excuse to eat chocolate.  A national holiday devoted to this edible delight is the perfect excuse to indulge a little.

One little piece of chocolate will affect everyone in a different way.  If you’re worried about your sugar level you may want to steer clear of the sugary versions and opt for the “Sugar Free” alternatives.  “Sugar free” candy has come a long way.  Below is a list of some of the most popular candy companies that offer “Sugar Free” alternatives of their classically delicious products.

One of America’s most famous Chocolate Giants, Hershey’s, offers “sugar free versions of many of its beloved products, including the classic milk chocolate bar.  You can also enjoy those much loved Reese’s Peanut Butter Cups and York Peppermint Patties without having to worry so much about your sugar levels.

If you prefer to take a step up, Asher’s offers a whole line of Sugar Free candy products.  In addition to chocolaty favorites like Pecan Caramel Patties, Pretzel Bites, Butter Toffies, and Assorted flavored chocolates, Asher’s also offers Sugar Free versions of Jelly Beans and Gummy Bears.

Russel Stover, famous for their boxed chocolates found in every drugstore, also has a large “Sugar Free” chocolate line, including Triple Chocolate Mousse, Dark Chocolate Raspberry Truffle Miniatures, Almond Delights and Coconut flavors.  Russel Stover also offers Sugar Free Chocolate Delight Snack Bars, and a large selection of non-chocolate candies including Sugar Free Salt Water Taffys, Butterscotch candies, peppermints, and root beer hard candies. You can also get a Sugar Free version of the classic Whitman’s Sampler.

Ingredients in Sugar Free candies may not be good for everyone.  Whether you are celebrating National Chocolate Day with a sugary truffle or a Sugar Free alternative, you should enjoy your chocolate in moderation.

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