I wasn’t sure whether to laugh or cry when someone forwarded me an article in last Thursday’s Boston Globe about the new weight loss drugs Qsymia and Belviq. The story referenced a column in JAMA Internal Medicine that raised concerns about “the drugs’ modest effectiveness and safety concerns”.

Now, don’t get me wrong – I’m all for raising the red flag on drug safety. It is, after all, what we do here at AdverseEvents.

But, I was troubled by the conclusions of the JAMA column authors. They raised concerns that the FDA approved these drugs on iffy safety profiles and have requested further trials to better determine side effect risks. But, according to the column, these “safety trials are behind schedule” and “until there is more convincing evidence about the cardiovascular safety of these drugs, physicians and patients should approach them cautiously”.

That’s the part that made me want to both laugh and cry. You see, this is just the same old routine from the ivory tower of academic medicine. Clinical trials trump all and until these new studies are complete, reviewed, and blessed we should just continue to “approach them cautiously”. What the heck does that even mean?

In the interim, here’s what’s going on in the real world:

Qsymia was one of 105 drugs that we requested real world updated side effect data on as part of a massive Freedom of Information Act request at the end of 2013.

What we learned was that there have been a total of 112 reports of serious side effects for Qysmia since approval in July of 2012. The most reported side effects included Paraestesia (tingling), Dizziness, and Headache. The most unexpected included Somnolence (drowsiness) (8 cases), increased heart rate (5 cases), and blurred vision (5 cases) – although it’s important to note that all of these are all on the drug’s label warning. There have been 6 reported cases of hospitalization and 1 case report listing death as the outcome.

How does that stack up against other obesity treatments? We score Qsymia with a lower RxScore (indicating a better overall safety profile) than the other primary FDA approved weight loss medication Xenical. Xenical has a much longer market history and much more robust side effect reporting, but it also shows a high number of serious side effects occurring at an unexpected rate that are not currently on the warning label.

My point isn’t to defend Qsymia and bash Xenical. We don’t have a dog in that fight. My point is that all prescription drugs have side effects and practitioners and patients need information to be able to balance the dangers of those side effects to the benefits that the medicines can provide.

What makes me frustrated, however, is the conclusion drawn in the JAMA column that we should wait around for another year or two for the clinical trials to run their course. This is an outdated and potentially dangerous notion, especially when real-world side effect data is already available for analysis.

Should we forsake clinical trials? Of course not.

Should we have to wait for post-approval trials to run their course before making an informed decision about a medication when there are a slew of relevant real-world side effect data available for review and study? Of course not.

Pharmacy Directors, prescribers, and other healthcare participants do not have the luxury of “approaching cautiously” while waiting for more studies. They need information now to make informed formulary and patient care decisions in the real world.

I invite anyone who needs more information on the real-world safety profiles of Qsymia and 4,100 other FDA approved medications to register for a trial of our AdverseEvents Explorer.

 

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Jim Davis

Jim Davis

Executive Vice President

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Topics: Drug / Indication Information

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.