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Articles Tagged with FDA

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At some point, you just have to ask — What’s next? That’s a good question for the diabetes drug Invokana. At the Blackwell Law Firm we began investigating Invokana when the drug was initially linked to ketoacidosis. If you want to learn the basics about Invokana and its development as a diabetes drug, we have a section devoted to the topic on our firm website. As discussed in that section, ketoacidosis is a serious and potentially fatal build-up of acid in the blood. Symptoms of ketoacidosis can include:

  • Confusion
  • Abdominal Pain
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Invokana continues to be linked to serious health problems. Our office has closely followed developments with the diabetes medication Invokana since it was first approved by the Food and Drug Administration (FDA). Although relatively new to the market, many health injuries are already associated with this drug.

Invokana (canagliflozin) is marketed to treat Type 2 diabetes. The drug is one of a relatively new class of diabetes medications. This class of medications is known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. Other SGLT2 drugs include Jardiance, Farxiga, Glyxambi, and Xigduo XR. These drugs alter kidney function to prevent reabsorption of glucose into the patient’s blood stream. For more detailed information, please read the report on our firm website.

We have watched Invokana closely because of its association with the health problem diabetic ketoacidosis. This is a dangerous adverse health issue suffered by some patients taking Invokana. What is diabetic ketoacidosis? It is a build-up of acid in the blood. Symptoms can include abdominal pain, nausea, fatigue, difficulty breathing and confusion. In May 2015, the FDA issued a safety communication warning patients about the risk of ketoacidosis from Invokana.

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Serious Injury? We Can Help.
Consumer health and safety should be the NUMBER ONE GOAL of drug research. Yet, it’s not. The primary goal seems to be greed. Immediate greed for quick and massive profit. For some drug companies that means — conceal bad studies revealing drug dangers, give the FDA just enough positive information to get the drug to market, and then sell as much as possible until the dangers come to light. Because of this, many patients are needlessly injured each year by dangerous and defective drugs that should have never been sold. Often, it’s too late for the families harmed.

Below are just a few recent examples of how drug companies view real research and the documents that explore the safety of their products:

  • Transvaginal Mesh— My office represents numerous women in Huntsville and throughout northern Alabama who suffered injury from mesh products by manufacturers Boston Scientific, Johnson & Johnson’s Ethicon, Coloplast, and American Medical Systems. These companies marketed their mesh products through a loophole in our law that allows certain dangerous medical devices to be sold prior to proper testing. Basically, the process is turned upside down and sales come before safety testing. Thousands of women suffered serious, and often disabling, injuries after being implanted with these dangerous and defective products. We have worked closely with attorneys in other states. The dedication of the many excellent attorneys representing injured victims of these defective products is the only reason the truth about the dangers is now coming to light. Yet, some manufacturers continue to avoid producing the complete information which the public deserves. On February 4, 2014, the Court hearing the claims against Ethicon, entered an Order saying the following:
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I recently spoke at a seminar where we had a great discussion about ongoing medical device and pharmaceutical litigation. None of these companies paid for product attention. None of these companies paid for sponsorships. We were not promoting their products. Rather, we were discussing the injury, pain and death they needlessly cause.

Drug marketing is everywhere! You see drug and device ads on television. You see drug and device ads throughout newspapers and magazines. I have concerns about these direct-to-consumer ads for products that really require medical expertise. Yet, these visible ads are not the worst problem. What about the secret payments to physicians and medical groups in return for pushing selected products on unsuspecting patients? These same advertising drug companies provide millions upon millions of dollars to various physicians and medical groups. This includes payments directly to physicians. It also includes trips to fun places. I deposed a surgeon in one of my medical device cases who testified the device manufacturer regularly flew him to Las Vegas. Surprise! The medical device company put its “lab” near the casinos. The huge infusion of cash to select physicians who are supposed to be unbiased in their assessment and research raises serious questions. Would you like to know whether or not your doctor is receiving money from the pill company to push its product?

According to the Birmingham Business Journal, we now learn drug companies paid Alabama doctors $4.6 Million in 2009-2010. A recently released document shows that a single local physician, an internist in Decatur, even received over $200,000.00 in payments from GlaxoSmithKline, alone. Why do you think the drug company is paying a single local physician so much? For reference, that’s the same company that made billions marketing Avandia before the public became aware of its terrible dangers. The same company that apparently hid negative test results concerning Avandia. The same company that may have paid one member of the FDA advisory panel. Do you see a pattern of secret money to promote risky and dangerous products? I don’t mean to single out the local doctor just for pocketing $200,000 from drug maker GlaxoSmithKline. The same Decatur physician also received significant money from another pharmaceutical giant as well.

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