Articles Tagged with FDA

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Untitled-design-3-300x300JUUL Made False Marketing Claims (To Young Adults)

In September 2019, the Food & Drug Administration (FDA) issued a warning letter to JUUL Labs. The FDA warning letter ordered JUUL to stop marketing its product as safer than cigarettes. The FDA cited testimony that JUUL had been marketing its vaping products as “modified risk tobacco products.” That means, the company claimed its product presented a lower risk of tobacco-related disease or was less harmful than traditional tobacco products. Here’s the real catch — JUUL actually presented at school programs. The Congressional testimony contained evidence of a JUUL representative actually speaking at a school and telling students their product “was much safer than cigarettes.” You can read more about the FDA letter in a Washington Post article titled FDA Blasts JUUL For Illegally Marketing E-Cigarettes As Less Harmful Than Regular Cigarettes.

JUUL Pods Have High Levels Of Nicotine

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Blackwell Law Firm: Huntsville Personal Injury AttorneysI remember listening as the doctor testified about his trips to Las Vegas. That’s where the medical device company took him to “discuss” its product. After these trips to Las Vegas, the doctor returned home and began implanting the product into countless Alabama patients.

At the time, I was surprised. Shocked. But, that was also the first time I had deposed an implanting doctor in one of these cases. In the years since, I have seen far too many instances of drug and device companies trying to tempt physicians into prescribing or implanting certain products.

In some cases, the physician may not even be fully trained in the potential issues of the drug or product at issue. I think this is an issue with transvaginal mesh implants. These products were heavily marketed to local physicians and regularly implanted in women. Yet, the potential problems from mesh implants can be tremendous. When problems occur, the same implanting physicians are often unable to help. I recently deposed a surgeon at a major research hospital who has tried to help one of my clients suffering from implanted mesh. Here is what that specialist said:

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Blackwell Law FirmIn a prior post, I asked “Can A Simple Blood Test Reveal Traumatic Brain Injury?” At the time, the research looked promising. After writing that prior post, we continued to follow developments. Now, the Food & Drug Administration (FDA) has approved a blood test for this purpose.

Why is a blood test for traumatic brain injury (TBI) significant? In a short answer — Many TBI victims suffer without a diagnosis, without treatment and without understanding. Following a traumatic incident, emergency rooms frequently fail to diagnose TBI cases.

Think about it. After a serious accident, you rush to the hospital. Suddenly, you are in a crowded emergency room. It can be a chaotic scene. While emergency rooms are designed to handle “emergencies” like yours, they are also overflowing with patients who lack the resources or finances to seek basic care elsewhere. Emergency room physicians and nurses work hard. They have hard jobs. They work to treat all patients. But, life and death issues take priority. They must. With so many patients and so many problems, many significant TBI cases go undiagnosed and untreated. After all, many TBI patients look normal.

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Personal Injury -- Blackwell Law FirmA recent study estimated a significant percentage of medical studies are ghostwritten. The really troubling detail — Up to half of all medical studies may be ghostwritten by companies with a financial interest in the research.

Next time you see or read a medical article listing a researcher or physician as the author, take a step back. Did the listed author really write the article? Maybe. Maybe not. Maybe a drug company or medical device company funded and really authored the article.

Consider the revealing article published by former ghostwriter Linda Logdberg. The article is titled Being the Ghost in the Machine:  A Medical Ghostwriter’s Personal View. How does Ms. Logdberg now feel about her former career?

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Recent research shows a dangerous problem with many newly approved drugs. Life-threatening side effects are common in the years following FDA approval. An article titled “Study: Side effects emerge after approval for many US drugs” details the new research. The article’s opening paragraph sums it up:

Almost one-third of new drugs approved by U.S. regulators over a decade ended up years later with warnings about unexpected, sometimes life-threatening side effects or complications . . .

This new study followed all prescription drugs approved by the Food and Drug Administration (FDA) from 2001 through 2010. The drugs flagged because of serious post-approval problems included medications for common medical problems such as arthritis, infections, blood clots and depression. The study’s lead author (an associate professor at Yale University) said “the large percentage of problems was a surprise.” As for me — I’m not surprised.

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Our office has closely followed developments with the diabetes drug Invokana. Invokana is in a class of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. This is a relatively new class of drugs also including Farxiga, Jardiance, Glyxambi, and Xigduo XR. These drugs treat diabetes by altering kidney function to stop reabsorption of glucose into the patient’s blood stream. We have a page on our firm website discussing these drugs, how they work and their link to diabetic ketoacidosis. Despite being a new drug at the time we published our initial page, Invokana had already been linked to numerous adverse health reports. Since then, even more potential injury risks have emerged. You can read about these developments in several posts on this blog.

In its recent QuarterWatch report, the Institute for Safe Medication Practices (ISMP) calls Invokana a “dangerous gamble.” The ISMP report opens with the following paragraph:

The nation’s gamble in embracing new drugs for long-term use with only short-term clinical testing was most apparent in the rapid acceptance into clinical practice of a new class of oral diabetes drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. There are now three such agents, canagliflozin (INVOKANA), dapagliflozin (FARXIGA), and empagliflozin (JARDIANCE). Since approval, evidence of multiple safety problems has emerged.
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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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