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Articles Posted in Drugs

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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 to Pancreatic Cancer

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Asia’s biggest drugmaker, 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 over 3,000 lawsuits, alleging Actos caused bladder cancer or other ailments among patients.

Over 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. The plaintiff is a 69-year-old man who took Actos for over 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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The 11th Circuit affirmed summary judgment in a lawsuit where the plaintiff claimed he went blind from the use of Genetech’s macular degeneration drug.

Plaintiff acted as his own lawyer in this case. His argument was “C’mon, look at the temporal relationship here” instead of bringing an expert who could testify – as Georgia law requires – that the drug at issue, Lucentis, caused his vision loss.

Putting together a drug injury case that can get past summary judgment is difficult. Most practicing attorneys in the country could not do it, much less a pro se plaintiff. This is true, even if the facts are on your side.

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The FDA said yesterday that Mirapex, a drug used to treat Parkinson’s disease and restless leg syndrome, may cause heart failure.

I don’t think anything is conclusive, but the results of recent studies show a potential risk of heart failure. More studies are necessary to confirm these findings, but if you are taking Mirapex, you have to be concerned. This was not just a single study that could have gone awry. Instead, the study looked at the pooled analysis of multiple randomized clinical trials. Researchers found that heart failure occurred more frequently in patients taking Mirapex than in patients taking a placebo.

Should you stop taking Mirapex because of this risk to your heart? Well, one good rule of thumb is don’t make medical decisions based on what you read on a legal blog. Really, you should be talking to your doctor about the potential risks and your options. The FDA agrees, saying that patients taking Mirapex should continue to do so and consult their doctors.

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What happens when a drug company fails to warn of the risk of the product and the prescribing doctor later learns of the risk and continues to prescribe the drug?

The 2nd Circuit took this issue in McElroy v. Eli Lilly. In this case, the plaintiff’s psychiatrist continued prescribing of Zyprexa – a drug that treats bipolar disorder and schizophrenia – even after being told of Zyprexa’s diabetes risk. In fact, the doctor even upped the dosage of the drug after March 1, 2004 (the date Eli Lilly sent a “Dear Doctor” letter to the medical community warning of the diabetes risks associated with the Zyprexa).

The 2nd Circuit found that the plaintiff”s “continued prescription of Zyprexa for more than two years after the medical community knew or should have known about the drug’s risks indicates that his prescribing decision was not affected by those risks.”

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The FDA has announced a nationwide (retail level) recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, as it has been determined that some tablets from the lot exceed the weight specification, and could be “super-potent” for the ingredients Hydrocodone Bitartrate and Acetaminophen.

The recall affects the following:

  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiration date 12/13
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Last month brought changes to forty-one (41) medical product labels (up from 35 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, please refer to the summary of meds. By clicking onto the drug name, you can view the detailed summary which will identify the safety labeling section and revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

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The Accutane MDL judge granted summary judgment in one of the cases pending before him, ruling that warnings about inflammatory bowel disease (IBD) that were on the drug’s label at the time the plaintiff took Accutane were adequate because a prescription drug is not defectively designed when it is accompanied by an adequate warning, at least under New York law.

What about the defective design claims? The court found that design defect claims under New York law are not separate and distinct from plaintiff inadequate warnings claims because that state’s law is that an adequate warning bars any design defect liability against the manufacturer.

You can find the court’s opinion here.

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Last month brought changes to thirty-five (35) medical product labels (down from 43 changes in April), 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, please refer to the summary of meds. By clicking onto the drug name, you can view the detailed summary, which will identify the safety labeling section and revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

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As a longtime sufferer of headaches, I know how great it is to find something that honestly works to quickly take away the pain. Would I pay $2.45 for a pill for to take away the pain, when a few weeks ago that same pill was $.02 per pill? That, I’m not quite sure. It sounds crazy, but that is exactly what seems to be happening.

In January of this year, Excedrin Migraine, amongst a few other over-the-counter medications, was recalled. The drugmaker Novartis recalled these items after issues at its production facility in Nebraska lent themselves to contamination. As a result, Excedrin Migraine was pulled from the shelves. When will it return, nobody knows, but Novartis says this:

We are working hard to return products to store shelves as soon as possible. Novartis Consumer Health will restart production on a line-by-line, product-by-product basis to ensure control and adherence to our high standard of quality and expects to begin shipments of a limited portfolio of products in the second half of the year. We are currently in the very early stages of validating our manufacturing processes.