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Black Box Warnings May Save Your Life
This often comes as a major surprise for patients: that when a prescription drug is known to be effective, and is approved by the FDA for some patients, that doesn’t mean it’s effective and safe for all patients. It’s true that some people may be allergic, or the drug might have been prescribed to treat the wrong diagnosis, or the patient may not take the drug properly and over (or under) dose…. …But those situations are not what I’m addressing in this post. Instead what I’m describing is the fact that patients die or are harmed every day from FDA-APPROVED pharmaceutical drugs, drugs their doctors prescribed for them to take to improve their health and medical problems. (I’ll mention here that no doctor prescribes a drug with an intent to kill his or her patient. But that does not mean a drug is safe for everyone, including you.) Sometimes the FDA approves a drug that may help some patients, but can be truly dangerous for many others. Here are two examples: Flouroquinolones are strong antibiotics with brand names like Cipro and Levaquin, and are often used to clear up problems like urinary tract infections or pneumonia. However, some patients found themselves with tendon ruptures from the drugs. Avandia is a drug developed for patients with diabetes. Many diabetes patients also suffer from heart disease, and Avandia was found to increase their chances of suffering heart attacks. Xarelto is a drug that prevents blood from clotting. Patients who experience severe side effects often bleed to death as there is no antidote. For both these drugs (classes) the FDA ultimately issued what is called a Black Box Warning. Because these drugs were found to be harmful for many of the people they were originally intended to help, a Black Box Warning is the strongest effort the FDA can make to warn doctors and patients about the potential for harm if given to the wrong patient. The name “Black Box” comes from the fact that warning itself, as printed in the materials that accompany the drug,is surrounded by a black box. When the FDA issues a Black Box warning, it is telling the drug manufacturer that it is one step short of removing the drug from the market. It’s a recognition of how harmful the drug can be if given to patients who are at risk of developing the possible adverse side effects.…
