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Beware Black Box Warnings on Your Drugs

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When the FDA determines that a drug has a really serious side effect, it requires the company to highlight the problem in bold type with a black border at the top of the prescribing information. This "black box warning" is designed to alert health professionals to the special risk.

Although doctors often like to put the best possible spin on the drugs they prescribe, patients too should be informed about the caution in the black box. Most antidepressants, for example, carry a warning about an increased risk of suicidal thoughts and actions. The caution for fluoxetine (Prozac) includes this language: "Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber."

When patients or their families are not informed of this danger, the results can be tragic.
A reader shared her story: "I am a parent and a highly educated professional. Several years ago, my doctor prescribed Prozac to help me with short-term insomnia. She told me fatigue was the only side effect.

"Ten days later, with no history of depression or anxiety, I had one mission: I needed to kill myself. I wasn't sad or angry. I just had a direction I needed to follow, and it wasn't negotiable.

"I sent my children to my mother's house in another state. (As teenagers, they were all pretty self-absorbed and had no idea I was upset.) I got a handgun from my safe and shot myself in the chest.

"People may think suicide is fast and easy, but let me tell you it is not. I never lost consciousness. I lay on my garage floor for many hours, vomiting blood in excruciating pain. I couldn't move or see out of my right eye. I was just waiting for the end.

"My ex-husband broke into my house and found me. My last memory of that day is being put under anesthesia at the trauma center.

"When I woke up a week later, a psychiatrist asked me why I was taking Prozac. I told him it was for insomnia. He said that Prozac can have the side effect in some people of suicidal ideation, and he asked if I knew that. I did not.

"The power of a medication to alter your brain chemistry to the point of self-destruction is too dangerous to prescribe without stringent warnings. I have become an advocate for suicide survivors. Hundreds of people have shared stories similar to mine."

It took many years for the FDA to recognize that antidepressants could actually trigger suicidal thoughts. The very notion seemed counterintuitive. But we now know this is a real risk and patients must be informed.

Black box warnings exist for dozens of drugs, including antibiotics such as ciprofloxacin (Cipro) and levofloxacin (Levaquin) that can cause tendon rupture and ibuprofen (Motrin) and other NSAID pain relievers that increase the chances of heart attack or stroke.

Busy doctors may forget to mention a black box warning. To find out if your medicine has one, check the prescribing information at DailyMed. You can also learn more about precautions for prescription drugs in our book, Top Screwups Doctors Make and How to Avoid Them.

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2 Comments

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I would like to hear more. A beloved friend committed suicide because of Prozac. It was this column which first alerted me to the side effects. Please keep spreading the word about the very real dangers of modern drugs.

I worked for a pharmaceutical company before I retired. When a medication has a black box, it has serious problems. It should only be used if no other medication is available for treatment. Often the black box is the precursor of being pulled of the market. So great caution is indicated!

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