Articles Tagged with clinical trials

Invokana Black Box Warning After Studies Show Higher Amputation Risk

Published on: October 27, 2017 | By Clay Hodges

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

FDA Chief Urges Politicians to Respect Science in Drug Testing

Published on: January 24, 2017 | By Clay Hodges

Dr. 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:

“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.”

FDA Announces Hearings on Off-Label Prescription Drug Use

Published on: September 13, 2016 | By Clay Hodges

Communications between pharmaceutical companies and medical device manufacturers and physicians are highly regulated by the federal Food and Drug Administration (FDA), but the agency, as much as it may want to be, does not have the final say in all regulation. These companies have First Amendment commercial free speech rights (though they’re not as broad as the free speech rights individuals have) and there’s a tension between what the FDA wants companies to say, what these companies want to say, and what the courts say the companies can say.

The agency in late August published a notice of public hearing and request for comments concerning manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016 in Silver Spring, Maryland, and in case you want to present information you must register by October 19. You could also send in written comments by January 9.

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