Presented by ConsumerSafety.org
If you’ve ever read the label of prescription drug packaging, you might have noticed a warning surrounded by a black box. This type of warning, aptly named “black box warning,” indicates a severe risk level to the consumer. Since this is the most severe level of warning issued by the Food and Drug Administration (FDA), you might expect it to be restricted to an extremely niche class of drugs where the potential damage outweighs the side effects, like in the case of chemotherapy. But unfortunately many of these drugs are all too common.
Infact, some of the most commonly prescribed drugs on the market have grave black box warnings, that unfortunately many consumers and their doctors simply gloss over. Most people wouldn’t know this, but Xanax is one of them.
Yes, the Xanax that’s become an unfortunate part of pop culture with songs being written about it and tens of millions of annual prescriptions in the U.S. alone.
But according to the FDA warning, taking Xanax can cause serious sedation and respiratory disorders. It also has an addictive potential, so it should never be administered to patients with a history of addiction problems.
And sometimes black box warnings are only added after the pharmaceutical drug has been on the market for years and potentially impacted millions of consumers. Consider the case of Pradaxa, a popular anticoagulant that helps prevent the formation of blood clotting. When it hit the market, it carried no black box warning at all. Then, in 2013, not one but three black box warnings were added to the packaging.
Unsurprisingly, years later there are hundreds of millions of dollars of lawsuits being paid out by Pradaxa manufacturer Boehringer US due to undisclosed risks of taking the drug they rushed to market. The potential side effects now listed in the black box warning for this drug are enough to give any potential patient pause: increased stroke and cardiovascular risk when course discontinued before its completion, increased risk of hematoma (which is a swelling of clotted blood within body tissue).
The question we need to be asking ourselves before taking prescription drugs with black box warnings is: “would my doctor take this?” “Would my doctor prescribe this to their children?” Unfortunately, the answer would likely be “no” in many cases. There is a strong financial incentive to prescribe drugs to patients even when the risks may be at parity or outweigh the benefits.
Another factor in the equation is that drug reps simply aren’t discussing the harmful side effects of the drugs at all when they meet with doctors.
Recent data showed that almost 60% of the time, pharmaceutical sales representatives didn’t provide any information at all about serious side effects of the drugs. And it doesn’t stop there. The same study published in the Journal of General Internal Medicine demonstrated that 57% of the time the side effects were ignored pertained to drug pitches for black-box drugs! So there are sales reps out there motivated by improving their bottom line, who are totally neglecting to tell doctors that the drugs they’re pushing could lead to death in some cases.
Here are some other commonly prescribed drugs that carry black-box warnings you probably weren’t aware of:
The “study” drug of choice among college students across the U.S. has a similar molecular structure to other amphetamine drugs like meth. It logically follows that it is extremely addictive and likely to get abused, resulting in a black box warning. It can also increase risk of sudden death.
Ciprofloxacin (Bacterial Infection)
Antibiotics are a pretty standard course of treatment for bacterial infections in the U.S, so someone prescribed cipro is probably unlikely to question their doctor’s decision, assuming it’s relatively benign. Unfortunately the drug has been proven to increase the potential for inflammatory conditions like tendinitis, as well as serious nervous system damage resulting in neuropathy. Ask your doctor for an alternative if possible.
Vicodin (Pain relief)
One of the key drivers of the opioid crisis, Vicodin used to be prescribed like candy after any level of surgery, from back surgery down to wisdom tooth removal. Thankfully the regulations have gotten a bit more stringent concerning its use, because this drug is highly addictive and can harm the liver.
Since your doctor probably wouldn’t take these drugs unless absolutely necessary, it’s critical for you as a patient to perform due diligence on their side effects and weigh the risks against the benefits. Don’t wait for your doctor to give you all the information, because they’re likely pressed for time and/or haven’t read it themselves. In the age of information you truly are your own doctor, so take the time to educate yourself so you don’t end up as a statistic on a black box somewhere.