July 2013 Medication Safety Labeling Changes

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:

Depakene (valproic acid) Capsules and Oral Solution
Depakote (divalproex sodium) Delayed Release
Depakote ER (Extended Release) Tablets
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules)
Depacon (valproate sodium) Injection
Nizoral (ketoconazole) Tablets
Nucynta (tapentadol) Immediate-Release (IR) Oral Tablets
Prolia (denosumab)
Rapaflo (silodosin) Capsules
Sarafem (fluoxetine hydrochloride) Tablets
Agrylin (anagrelide hydrochloride) Capsules
Azor (amlodipine/olmesartan medoxomil) Tablets
Azulfidine EN-Tablets (sulfasalazine delayed release tablets, USP)
Bactrim and Bactrim DS Tablets
Benicar (olmesartan medoxomil)
Benicar HCT (olmesartan medoxomil/ hydrochlorothiazide) Tablets
Dulera (mometasone furoate/formoterol fumarate) Inhalation Aerosol
Elspar (asparaginase)
Geodon (ziprasidone) Capsules, Injection and Oral Suspension
Lupron Depot (Leuprolide Acetate for Depot Suspension)
MultiHance (gadobenate dimeglumine) Injection and MultiHance Multipack (gadobenate dimeglumine) Injection
Pentasa (mesalamine) Controlled-Release Capsules
Prozac (fluoxetine hydrochloride) Delayed Release Capsules
Symbyax (olanzapine and fluoxetine hydrochloride) Capsules
Tribenzor (olmesartan medoxomil/ amlodipine/ hydrochlorothiazide) Tablets
Vivitrol (naltrexone for extended-release injectable suspension)
Zelboraf (vemurafenib) Tablets

Little Risk in Diabetes Drugs Says European Regulators

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.

The recent European news is music to the ears of these diabetic drug manufactures who had more than $9 billion in global sales last year. Januvia and Janumet, also manufactured by Merck, together earned $5.7 billion.

How, Then, Do We Explain the Byetta/Januvia Lawsuits?

This is one study that goes the other way.  But it flies in the face of all of the next evidence suggesting that these drugs can cause pancreatic cancer.  Keep in mind that these were very small trials. The FDA is certainly not buying into and and they are reserving judgment.

I think this is the history of many mass tort claims:

  1. Problem becomes obvious
  2. Lawyers start filing suit, probably prematurely
  3. The science and the studies begin to follow #1
  4. There are a few rebuttal studies, usually of dubious methodology
  5. The case start going to trial
  6. The science becomes even more clear
  7. The case settle in massive numbers

I think we are on Stage #4 right now.

Filing Suit

If you or a loved one has used Januvia or Janumet, or any of the other well known diabetes drugs, and suffered from acute pancreatitis or pancreatic cancer, please call one of our attorneys at 800-553-8082 or click here for a free no obligation consultation.

Update: Pfizer Opposes Lipitor MDL

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.

This would not be the first Lipitor MDL. U.S. District Judge Peter Sheridan presides over an MDL in New Jersey. In that case,  plaintiffs’ lawyers allege Pfizer improperly extended its patent rights on the anticholesterol drug Lipitor and then when the rights were expiring,  conspired with the a generic drug manufacturer Ranbaxy to block the generic version of the drug.  This lawsuit is a totally different animal but there is a common thread to both cases: allegations that Pfizer is greedy.

The U.S. JPML is expected to schedule oral arguments over the motion to consolidate the Lipitor diabetes litigation for an upcoming hearing session, scheduled for July 25, 2013.

We will continue to give you the latest updates in the Lipitor cases.  Bookmark this page.

And… if you think you have a potential Lipitor claim – particularly if you are a woman with diabetes – we will give you a free on-line case evaluation.

 

Will We Have a Lipitor Class Action Lawsuit?

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.

The MDL would create a “sort of” class action where all of the cases would be consolidated in federal court.  The plaintiffs have suggested the case be centralized in South Carolina.

There have been a number of mass tort “the drug caused me diabetes” cases that have failed.  With Lipitor be different?  Let’s see.

Lipitor Diabetes Lawsuits

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.

Although statins have been in use since the 1980s, it was not until the past ten years when long-term data was analyzed to find the Type-2 diabetes correlation.  Researchers are not certain why statins are correlated with higher diabetes rates.  One potential explanation is that statins increase blood sugar levels.

Lipitor is one of the stronger statins on the market today.  High strength statins carry the increased risk for diabetes, whereas weaker statins generally do not.  Drugs like Lipitor become particularly risky when used in high doses.  Multiple studies have confirmed that when strong statins are used in a high dose manner the risk for diabetes greatly increases.  The bottom line with these drugs is that the ideal dosage has not been established.

More than 20 million Americans currently take statins.  If the studies are correct and about one out of every 200 statin users will develop diabetes, this means that 100,000 more people will develop diabetes than would otherwise do so.

Adding to this risky equation is the fact that millions of statin users take them preventatively.  In fact, some studies have found that in these users, the heart attack and heart disease reduction rate is only 2 per 100.  So if all this data is to be believed, out of every 200 statin users, four will be benefitted and one will develop diabetes.

Getting the full picture of long-term statin use will take another 20 years.  In the meantime, people taking statins needs to be aware of the very serious risks that drugs like Lipitor could pose to their overall health.

Getting a Claim Started

Will your Lipitor diabetes case be a successful lawsuit?  The answer is simple: I don’t know.  But we are now reviewing these cases and trying to figure out whether they may be viable claims.  Certainly, it is fair to say that women have much better claims than men do for a variety of reasons.   If you want your Lipitor diabetes case evaluated, contact us here.

Januvia, Byetta, and Pancreatic Cancer

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

These drugs behave differently than older pharmaceuticals, so here’s a quick breakdown of the science behind each treatment. Type-2 diabetes is caused by hyperglycemia in the context of inadequate insulin secretion and insulin resistance.

These new drugs treat type-2 diabetes by using the gut hormone glucagon-like peptide 1 (GLP-1). This hormone is naturally secreted by endocrine cells in response to eating food and it increases glucose-medicated insulin secretion. This means that GLP-1 tells the pancreas to make insulin. During this process, the hormone is degraded by the enzyme dipeptidyl peptidase-4 (DPP-4). Januvia and Byetta treat diabetes by sustaining GLP-1 receptor activation. Byetta, an injectable drug, does this by being a GLP-1 agonist that resists DPP-4 degradation. Januvia (sitagliptin), an oral drug, uses inhibitors of DPP-4 to enhance the levels of endogenously secreted GLP-1. So essentially these drugs get to the same problem by starting at different ends; Byetta adds chemicals that act like GLP-1 and Januvia inhibits the DPP-4, which degrades the natural GLP-1.

Recent studies have confirmed that drugs that act like GLP-1 inflame the pancreas. By spiking hormone levels, the drugs change the normal GLP-1 pathway to the pancreas and also speed up the creation of the cells that line the pancreatic duct.

The problem is that researchers also believe that pancreatic cancer usually starts in those exact duct and islet cells. One UCLA study referenced FDA statistics to observe a six-fold increase in cases of pancreatitis in Byetta and Januvia users.   Let’s say those numbers are inflated a little.  There are still unbelievable and they still underscore what these drugs are doing to the pancreas.  Additionally, the study also found a 2.9-fold increase in pancreatic cancer in those using Byetta and a 2.7-fold increase in pancreatic cancers for those using Januvia. Both drugs are also linked to increased rates of thyroid cancer but not other cancers generally.

These findings are likely due to the fact that diabetes drugs are used for long periods of time. Type-2 diabetes does not have a cure thus patients can be on a single treatment for decades. If patients were using Byetta or Januvia for a short period of time, it is likely that the pancreatic cancer correlation would not persist because the duct cells would not be over-stimulated every day.

The makers of Byetta One possible mitigating explanation for these health correlations is the fact that a high percentage of people with type-2 diabetes also suffer from being overweight. Being obese or overweight is directly linked with pancreatic cancer. For patients with a family history of pancreatic cancer, insulin and metformin could be safer alternative treatments. In fact, researchers have found that using Januvia when taking metformin removes the threat of increased pancreatitis. The link between weight and pancreatic cancer doesn’t eliminate the risks these drugs can pose, rather it is one part of the equation.

If you believe that you or a loved one may be able to link Januvia or Byetta to pancreatic cancer, contact us online or call us at 800.553.8082.

First Actos Trial

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.

Actos Settlements on the Horizon?

What issues Nesina may bring remains to be seen. The newer diabetes drugs have just not been better. But, if you think this is a harbinger of Actos settlements, I’m inclined to agree. Before they settle cases in massive numbers, they need to first get their next drug ready to go so they can keep the profits rolling. It is a sad commentary but it happens all of the time.

Jury Verdict: Turning of Tide in Fosamax Cases?

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.

Blow to Fosamax Cases

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.

What is the settlement value of the remaining Fosamax cases? A lot less than I originally thought they would be and even less after this verdict. Can the cases be turned around? Absolutely? But right now, if you had a graph of the expected average settlement value of Fosamax cases, I think you would see a downward slope. I’d like to be proven wrong.

You can read the full opinion in Secrest v. Merck here.

First NuvaRing Lawsuit Trials are Scheduled

Bellwether trials in the first state and federal NuvaRing cases have been scheduled.

The first “test” trial in state court is scheduled to begin on May 6, 2013, and will be held in the New Jersey state court. The first trial will be picked from a group of nine eligible bellwether cases. Seven will be pulmonary embolism cases, one of which resulted in death, and two stroke cases.

The first federal court bellwether trial has been scheduled to begin on July 8, 2013. This will also consist of both pulmonary embolism cases and stroke cases.

The outcome of these bellwether trials stand to have a great influence on how the rest of the NuvaRing cases will be resolved, currently more than 1,000 lawsuits strong. Really, the purpose of these trials in the MDL is to get both parties reading off the same sheet of music when it comes the settlement value of these case. My prediction and you read it here first: the cases set for trial will settle before a jury hears so much as a statement of the case. Like the Yaz cases, I don’t see defendants having the guts to try one of these cases. The evidence is just too stacked against them and a large verdict would dramatically change the settlement value of the NuvaRing claims.

Our lawyers are reviewing NuvaRing injury cases involving claims that NuvaRing can cause cardiac problems in women such as strokes, heart attacks, blood clots, deep vein thrombosis (DVT), pulmonary embolisms, and in some extreme cases, even death. Obviously, with the scheduling of the first bellwether trials, these cases are heating up. If you think you or someone you love may have suffered an injury from NuvaRing, call one of our NuvaRing lawyers at 800-553-8082. You can also get a free Internet consultation for your potential NuvaRing lawsuit.

  • August, 2013 Update:  Judge Rodney Sippel, who is presiding over the MDL, postponing the start of the first trial to January 27, 2014.  Why?  There still may be the possibility of a global settlement in these cases before the first trial.