Articles Posted in FDA

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Patient Loses Leg After Taking Invokana

Two recent clinical trials studying Invokana (canagliflozin) shed light on the diabetes drug’s alarming side effects. Canagliflozin is a type 2 sodium-glucose transport inhibitor (SGLT2 inhibitor) marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The medication works to lower blood sugar levels in the body by stopping the kidneys from reabsorbing blood glucose. Instead of the blood glucose staying in the body, it is removed with the body’s urine.

The clinical trials were named CANVAS and CANVAS-R, based on long scientific acronyms. The studies examined the effects of canagliflozin on patients with Type-2 diabetes. The trials discovered that leg and foot amputations occurred twice as often in patients taking canagliflozin as those treated with a placebo.

The risk for amputations broke down like this: 5.9 out of every 1,000 patients treated with canagliflozin suffered amputation, as compared to 2.8 out of every 1,000 patients treated with a placebo. Over a year’s time, the risk of amputation was 7.5 out of every 1,000 patients treated with canagliflozin, compared to 4.2 out of every 1,000 patients treated with a placebo. These are statistically significant results, meaning the risk of amputation for those people taking Invokana was large enough to cause alarm in the medical community.

In the clinical trials, amputations of the toe and middle of the foot were the most common; however, amputations of the leg, below and above the knee, also occurred. Some patients had more than one amputation.

Based on this new data, the FDA ordered new warnings, including a prominent boxed warning, to be added to the canagliflozin drug labels to explain and describe this risk.   Continue reading →

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Oxycontin and the Opioid Crisis
Over the past few years, an opioid epidemic has caused horrific problems for many regions of the country. In 2015 alone, the US Department of Health and Human Services estimated that 12.5 million people misused prescription opioids, causing over 33,000 overdose deaths. In 2013, the opioid epidemic resulted in $78.5 billion in economic losses.  In response to this tragic loss of life and the economic strain placed on many state and local governments, several lawsuits have begun.

What Exactly Are Opioids?

Opioids are synthetic or semi-synthetic forms of opiates (like morphine). Opiates are derived directly from the poppy plant while opioids are manufactured chemicals that are very similar to opiates.

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Textured breast implants and lymphoma
According to the American Society of Plastic Surgeons almost 280,000 breast augmentation procedures took place in the United States in 2015. Given the popularity of breast implants, a wide range of breast implant products have been released in the United States and the rest of the world. One such product is the textured breast implant.

Why Are Breast Implants Textured?

The purpose of adding texturing to the breast implant surface is to help the body keep the implant in place and avoid it from shifting. Another reason is to prevent a complication called capsular contracture, which occurs when the scar tissue that forms around the implant become painful and hard.

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Drug Companies MoneyLet me state the obvious: companies sell you stuff with one purpose in mind, to make money. McDonald’s doesn’t sell you quarter pounders because the company believes what you need to live a better life is to eat more quarter pounders. The NRA doesn’t advocate gun ownership because it believes you need to own five Glock 9s (you don’t), but rather so the gun makers can sell more guns. Mercedes doesn’t make expensive cars because its board of directors hope to improve the world by selling you cars with heated leather seats. Every company sets out first to last to make money. And the more money the better.

So it goes with pharmaceutical companies. The general public may sleepwalk through the concept and lazily presume that the primary motivation for drug companies is to develop medications which cure diseases or which minimize the suffering from diseases. But in fact the motivation for pharmaceutical companies is to make money, and a lot of it. This is rather obvious and not a controversial point, and I’d like to believe that every “BigPharma” corporate board would agree with me. But it helps to keep this profit motive in mind when doing research on drugs you have been prescribed or which you are currently taking. And to be hyper-vigilant about assessing any new “wonder drugs” which hit the market.

“Off-Label” Drug Promotion

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Drug TestingDr. Robert Califf is a cardiologist and the departing Commissioner of the Food and Drug Administration. He resigned his post last Friday, on Inauguration Day. Recently he gave a speech regarding his thoughts on the future of prescription drug testing, and he urged lawmakers to respect the value of science in approving and marketing prescription medications. According to Matthew Herper in Forbes magazine, Dr. Califf believes “the way forward requires putting science above politics and focusing on creating new ways to prove medicines help patients without causing undue side effects. Throwing out the standards that made the U.S. a global hotspot for medical innovation is not an option.”

Dr. Califf offered remarkable insight on the high failure rate of clinically-tested medications, as well as the urgent need for medications to do no harm:

FDA Approved Drugs“The most recent empirical data that we have at the FDA is that approximately 92% of drugs that go into human testing don’t make it to market because they have unacceptable toxicity, they actually don’t work for the intended purpose, or they can’t be manufactured at scale safely. Of the 92% of drugs that don’t make it to market, “100% had a lot of really smart people who thought they were going to work. If you were just going to start guessing about drugs you would do a lot of harm, because most of them would do more harm than good.”

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supermoon-724384_1920-287x300If you’ve kept up with politics even a little bit, you know how much gridlock exists in Congress. It’s amazing that anything can get done in Washington. However, a new law called the 21st Century Cures Act just passed with tremendous bipartisan support; this law must be really good, right?

21st Century Cures Act: The Good

The 21st Century Cures Act has the potential to save lives. For instance, it will provide funding for cancer research, fight painkiller drug abuse, advance Alzheimer’s research and improve mental health treatments.

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Xarelto internal bleedingThe blood thinning drug Xarelto has alarming side effects, the most dangerous of which is uncontrollable internal bleeding. While other anti-coagulants can also cause internal bleeding, it appears there is no available “antidote” for stopping internal bleeding in patients taking Xarelto. With warfarin, for example, vitamin K has been shown to stop bleeding. But there is no vitamin K “parallel” for people taking Xarelto. Thus, if internal bleeding starts, the patient taking Xarelto may simply have it wait it out and hope it stops on its own. Thousands of lawsuits have been filed and consolidated in New Orleans, Louisiana under MDL 2592.

In addition to Xarelto, there are three “novel anticoagulants”: dabigatran (PRADAXA), apixaban (ELIQUIS) in 2012, and edoxaban (SAVAYSA). Each has been shown to cause internal bleeding and injury.

The Institute for Safe Medication Practices (ISMP) is a nonprofit organization “devoted entirely to medication error prevention and safe medication use.” In June 2016, ISMP published a report on prescription medications causing injuries, including Xarelto. ISMP has authorized me to republish the following excerpt:

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