Articles Posted in Drugs

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The FDA has recently expressed concern about a certain group of medications called SGLT2 Inhibitors. This category of drugs includes popular prescription medications such as Invokana and Farxiga. Although these drugs have been, by all accounts, fairly successful when treating Type 2 diabetes. But,  they have produced their fair share of side-effects. Specifically, users of drugs such as Invokana are now reporting high levels of blood acid, the effects of which have landed some users in the ER.  While no deaths have been reported, there is no question that if these reports are accurate, these levels of blood acid could cause serious injury and death.  Accordingly, plaintiffs’ lawyers are investigating whether there is a connection between these drugs and these high acid levels and, if so, whether these drug makers knew about these risks and simply failed to inform patients and doctors.   If these dots are connected – and there is reason to think they might be – there are likely to be both serious injuries and lawsuits seeking compensation for those injuries.

SGLT2 Inhibitors

Invokana and Farxiga fall under an umbrella of a relatively new class of medications referred to as SGLT2 Inhibitors. The FDA considers this a fairly novel group of drugs and has only approved two medications within the class: Canagliflozin (Invokana) and Dapagliflozin (Farxiga). Both drugs are intended to treat Type 2 diabetes by inhibiting the amount of glucose that is absorbed in the bloodstream.

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medicineJuly brought changes to thirty-four (34) medical product labels (down from 44 changes in June), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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pills2According to a recent news release, regulators in Europe have concluded that there is little evidence that widely used drugs to treat Type 2 diabetes could cause pancreatic inflammation or pancreatic cancer.

In addition to the European agency, the Food and Drug Administration has been reviewing the safety of a big class of drugs that includes Januvia by Merck and the drugs Byetta, Bydureon and Onglyza, which are sold by Bristol-Myers Squibb and AstraZeneca.  These drugs, called incretin mimetics by the FDA, increase the body’s levels of a hormone that helps to control blood sugar levels.

They have, however, been linked to pancretic inflammation known as pancreatitis.  While the European agency said that the clinical trials had shown no increased risk of pancreatic cancer,the FDA said the trials were too small to draw firm conclusions.

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Last month we told you that a group of Plaintiffs had filed a motion to consolidate all federal Lipitor diabetes lawsuits before one South Carolina judge as part of a Multi-District Litigation or MDL.  To date, at least five different Lipitor lawsuits have been filed against Pfizer in three different U.S. District Courts throughout the country. The motion indicates that numerous additional complaints are expected.

lipitorNot surprising, Pfizer has indicated that they are opposed to the formation of coordinated proceedings involving Lipitor, arguing that the litigation is not sufficient big enough to require the consolidated proceedings and that such a procedure would only result in a wave of lawsuits filed by lawyers who may not otherwise be willing to litigate claims.

Lipitor has been linked to diabetes. Lipitor prevents an enzyme in the liver from creating low density lipids (LDLs).  The drug works to prevent the production of LDLs, a type of cholesterol that blocks arteries, and reduce the user’s risk of developing heart disease. Lipitor, which generates more than $14.5 billion in combined annual sales, is among the best selling drugs in the world.

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Five plaintiffs last week sought an MDL for federal lawsuits against Pfizer’s Lipitor.  The allegations are the same in all cases: the cholesterol drug caused them to develop diabetes.

The gist of plaintiffs claims is that the drug increased serum glucose levels causing diabetes.  Pfizer never properly let patients or doctors know of this risk so they could make a different choice or perhaps avoid this class of drugs all together. Accordingly, the suits allege, Lipitor is defective and unreasonably dangerous and the drug was sold with a warning that did not properly alert patients and doctors of the risk.

Not for nothing, Pfizer has been making money had over fist with Pfizer.  If you have help Pfizer stock in the last few years, you have gotten pretty rich in no small part due to Lipitor.

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Almost all prescription drugs carry the potential for side effects.  Some of these are minor, others significant.  Recent data suggests that Lipitor, the popular cholesterol drug, is strongly correlated with increased rates of Type 2 diabetes.

Lipitor (atorvastatin calcium), made by Pfizer, is a statin.  Statins reduce cholesterol by blocking specific liver enzymes.  By blocking these cholesterol-producing enzymes, the body begins to use cholesterol already in the blood.  This process lowers overall cholesterol levels as well as the risk of heart disease and heart attacks.

One problematic and newly discovered side effect of Lipitor is the increased potential for developing Type 2 diabetes.  Just last year the FDA mandated a change to Lipitor’s warning label.  The new label specifically tells users of the threat of diabetes.  Other statins, like Zocor and Crestor, were also required to make similar label changes.

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Type-2 diabetes is the most prevalent form of diabetes in America. 25.8 million children and adults in the US are being treated for the condition. Each year almost 2 million more people are diagnosed. In 2012 alone, the treatment cost of type-2 diabetes in the United States was $176 billion.

Two new drugs, Januvia and Byetta, offer new ways of treating diabetes.  By all accounts, they work well in treating diabetes.  But these drugs have also been linked to increased rates of pancreatic cancer.

The Theory That Links Januvia and Byetta and Pancreatic Cancer

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Asia’s biggest drugmarker, Takeda Pharmaceutical Co., is facing its first trial of lawsuits involving Actos. Alleged to have caused cancer in some patients, Actos was once the world’s biggest-selling diabetes drug. Like many diabetes drugs that were pushed on the market as the drug companies chased a gold rush of profits, lawsuits ensued. Now Takeda faces more than 3,000 lawsuits alleging Actos caused bladder cancer or other ailments among patients.

More than 1,200 suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges. The first federal case is set for trial in November 2014. In the meantime, Takeda faces its first case today in state court in Los Angeles. Plaintiff is a 69 year old man who took Actos for more than two years. Diagnosed with bladder cancer in November 2011, he is “gravely ill” according to the Judge that granted an expedited trial of his claim.

This trial comes one month after Japanese-based Takeda won U.S. regulatory approval for Nesina, a new diabetes drug to replace Actos.

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I wrote last week about how nothing is going right in the Fosamax cases. Now something did go right. A jury in New York yesterday awarded $285,000 to a plaintiff for Novartis on the defective design case. Which is fine, really. You only need one reason to win.

Is $285,000 a huge victory in a piece of litigation where some of the injuries are so utterly awful? No. But after a string of losses, a win is a win. Could this be the turning of the tide in these cases? I think Novartis is probably going to bet no and keep on trying these cases. We will see.

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In a blow to all Fosamax plaintiffs, but one in particular, the 2nd Circuit Court of Appeals upheld a defense verdict for Merck on Wednesday, finding no errors in the lower court’s rulings.

At particular issue was the trial court’s exclusion of plaintff’s key experts. The 2nd Circuit said that one of the experts offered irrelevant testimony that was properly excluded, and that the trial court correctly ruled that the expert could not give testimony about the competency of the FDA because the expert lacked the qualifications to do so. As for another expert (awkward writing because I hate using names when I don’t have to, sorry), the court found that the expert’s causation opinion was properly excluded because it was offered in his capacity as a treating doctor.

How does this make sense? Well, Florida law requires plaintiff to show that the treating doctor would have recommended that she stop taking Fosamax if they had known about the risks. Here, the treating doctor did not know she was taking Fosamax during the relevant time period.