Box warnings (often called Black Box Warnings) are the strictest alerts the Food and Drug Administration (FDA) puts on prescription drugs or drug products. Black Box Warnings are there to notify consumers about serious or even life-threatening risks when taking the drug.
What the FDA Does
It’s the FDA’s job to check, research and approve each drug that is to be put on the U.S. market. Although their review process is rigorous, once the drug goes to market safety issues may arise as a wider population begins using it.
Sometimes a Black Box Warning is applied to a new drug. But more often the warning is added when the FDA receives reports of adverse reactions to drugs that are already on the market. When that happens, the FDA researches the reports, talks with the pharmaceutical company who developed the drug, then confirms how serious the risk is. And if it is serious enough, a Black Box Warning is put on the product.
NSAID Black Box Warning
Over-the-counter and prescription drugs that control inflammation are among the most popular drugs people take. But recent studies have questioned their safety. That’s why in 2015 the FDA put Black Box Warnings on all NSAID labels to alert consumers to their risks. If you’ve never paid attention, here’s the NSAID warning:
May increase risk of serious and potentially fatal cardiovascular thrombotic events, MI (heart attack), and stroke; risk may increase with duration of use; possible increased risk with cardiovascular disease or cardiovascular disease risk factors; contraindicated for CABG peri-operative pain.
Increased risk of serious GI adverse events including bleeding, ulcer, and stomach or intestine perforation, which can be fatal; may occur at any time during use and without warning symptoms; elderly patients at greater risk for serious GI events.
Doesn’t sound like health issues you want to risk, does it? With more than 30 different types of NSAIDs, here are some familiar brand names:
- Ibuprofen (Motrin, Advil, Caldolor)
- Naproxen and naproxen sodium (Aleve, Naprosyn, Midol, Pamprin, Anaprox)
- Aspirin (Bayer, Anacin, Bufferin, St. Joseph)
- Diclofenac (Voltaren, Voltarol, Cataflam)
- Celocoxib (Celebrex)
You Should Be Concerned
Over the last twenty years, dozens of clinical studies have published research about the dangers of NSAID use. Despite the data and research the medical dangers of NSAIDs get downplayed. Part of that is because pharmaceutical companies make a lot of money on these popular drugs (and spend a lot advertising on them). And part is because when used in smaller doses, NSAIDs do relieve aches and pains. So as consumers, we like them.
But as a runner, or athlete, those warnings should be alarming since the side-effects tend to really kick in from overuse. And for training and recovering, runners and other athletes tend to overuse NSAIDs.
Here’s What You Can Do
Novo Renew was developed using the very latest nutraceutical advances to create a joint health blend whose soothing effects are far greater than each of its individual parts. By calming inflammation and helping your body repair damaged tissues while eliminating metabolic waste, Novo’s eight natural ingredients help you feel renewed energy and allow your body to repair without interference.
If you’re tired of worrying about the side effects of big pharma’s anti-inflammatory
NSAIDs, and you’re looking for a natural alternative to calm your inflammation, Novo Renew could be the right solution for you.