Articles Posted in Recalls

The Children’s Hospital of Philadelphia (CHOP) has been conducting a study on polyethylene glycol 3350 (PEG 3350), the active ingredient in MiraLAX, and its effect on a child’s brain. The study came about after reports that children have been experiencing behavioral problems after taking MiraLAX.

• If you are allergic to MiraLAX, you should talk to your doctor before you get the COVID vaccine (interesting article) and maybe bring an EpiPen when you get vaccinated

What is MiraLAX and how is it different?

Yesterday, I wrote an article noting a Danish study that concluded that there were no long-term cancer risks associated with NDMA-contaminated valsartan tablets. While NDMA might not have long-term cancer risk effects, it is not the only impurity found in valsartan.

Adverse events.

What Should You Do?

The lawsuits involving Pradaxa have been proceeding along. We think these are high value cases that will ultimately settle for a lot of money. It is not surprising to see Xarelto, Pradaxa’s little brother, also in the sites of injury and wrongful death lawsuits.

Xarelto Problems Increase

Xarelto, a relatively new anticoagulant in the same class of medications as Pradaxa, has been climbing the charts when it comes to adverse reports and even deaths. With a reported increase of 240% in the use of Xarelto after just a year and a half on the market, the problems associated with the increased numbers seem to be comparable.  With 968 adverse events having already been reported in 2013, which includes 72 deaths, the numbers are way up from the 750 adverse events reported in all of 2012, which included 58 deaths.

According to a transfer order issued last week, The U.S. Judicial Panel on Multidistrict Litigation (JPML) has agreed to consolidate all Stryker Rejuvenate hip replacement lawsuits filed throughout the federal court system, centralizing the cases before one judge. This will include both Rejuvenate and ABG II Implants.

Complaints filed involving any Stryker Rejuvenate or Stryker ABG II hip components will be transferred to one U.S. Judge in the District of Minnesota as part of an MDL or multidistrict litigation. There are currently at least 41 lawsuits filed against Stryker, filed in 16 different U.S. District Courts. This figure is expected to increase greatly over the coming months as individuals throughout the country continue to experience hip failures, which often result in the need for revision surgery. Typically designed to last 15 to 20 years, a recall was issued for Stryker Rejuvenate and ABG II hips in July 2012 after data suggest that the implants were prone to corrode or fret at the modular junction, increasing the risk of inflammation, loosening and eventual failure of the artificial hip within a few years.

As all the complaints involve similar allegations, the MDL has been created to reduce duplicative discovery, eliminate conflicting rulings from different judges, and to serve the convenience of the parties, witnesses, and the courts. As additional cases are filed in the future, they too will be transferred to the Minnesota Judge for coordinated handling before trial.

Diabetes is one of the most problematic illnesses of our society today. It is not a disease that stands by itself, but those who have it know all too well that the chances of it leading to many other illnesses for them are tremendous. A diabetic is most likely also going to end up with one or more of heart disease, kidney disease (resulting in dialysis), blindness, and peripheral neuropathy (incapacitating pain in the legs) to name just a few. The studies done on the disease and the medicines to treat it are too numerous to count. And yet, the incidence of this disease is steadily increasing every year. It’s no wonder that there is such a quest to get it under control.

The most common type of diabetes is Type 2. With this type, whereas the pancreas used to secrete enough insulin to take care of the sugar eaten, over time it becomes less and less efficient and produces less and less insulin. And the cells become more and more resistant to the insulin it produces. At some point, medication is needed to help the pancreas produce more insulin, and eventually, nothing can get it up to producing enough so the body then needs to be given the insulin that it so desperately needs, by way of injection. Type 1 diabetes is usually diagnosed in childhood. In this case, the pancreas is either not producing any insulin, or is producing a dreadfully small amount, and for whatever reason cannot be boosted by medication to produce more, so insulin injections must be started right away.

Diabetes Solutions

Shortly after Byetta was approved in 2005, questions about the risk of pancreatitis arose for that and other diabetic drugs such as Januvia. Now, new and more serious is the possible risk of pancreatic cancer, a virtually untreatable disease that kills most victims within a year.

Should these drugs be recalled?

With annual sales of more than $9 billion dollars, the futures of Januvia and other drugs in its class are being threatened due to latest studies by Dr. Peter C. Butler. A former editor of Diabetes, the flagship journal of the American Diabetes Association, he is not easy to ignore. Though he faces powerful opponents in the makers of the drugs, the Food and Drug Administration (FDA) and the European Medicines Agency have begun investigations based on his latest study that could lead to new warnings on the drugs, or possibly their removal from the market altogether. On the other hand, they may make no impact at all.

Byetta and Januvia, as well as other drugs in the class known as incretin mimetics, are used by hundreds of thousands of people with Type 2 diabetes. These drugs increase the level of incretin hormones in the body which in turn, raises insulin production in response to meals and decreases the amount of glucose (sugar) that the liver produces.

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