A woman who was suffering from persistent stomach upset was prescribed an anti-nausea medication. When she went to take her first dose, she noticed that the package insert included a warning that the drug could cause permanent muscle spasticity and she was understandably upset that neither her doctor nor pharmacist had mentioned the potential danger.
This is not an isolated incident. Right now, there could be a drug in your medicine cabinet that can cause serious or even deadly side effects...and you may not even realize it.
Karen Lasser, MD, an associate professor of medicine at Boston University School of Medicine, has done extensive research on these so called black box warnings. These safety alerts, Outlined with a black box, are printed on the literature you receive—a manufacturer's package insert and/or a printout from the pharmacist—as required by law, when you pick up certain prescription drugs.
Problem: Patients often overlook this information.
Black boxes are not limited to obscure, rarely used medications. Dr. Lasser said that many frequently prescribed drugs carry black box warnings including those that treat common conditions such as infection, diabetes, anemia, depression or blood-clotting problems. Potential side effects include difficulty breathing or swallowing coughing up blood, vision problems, seizures, as well as increased risk for heart attack or stroke, even suicidal thoughts.
Some medications carry the warning from the moment they are first allowed on the market. Others get a black box warning months or years later if the FDA receives sufficient reports of dangerous adverse reactions. Although some drugs that earn a black box ultimately are removed from the market, others continue to be available because the therapeutic benefits are deemed to outweigh the risks for many patients.
To find out if any of your medications carries a black box warning, you can…
- Ask your doctor. For current medications, continue to take as prescribed until you speak with your doctor-do not discontinue any medication on your own. Whenever you are prescribed a new medication, find out before leaving the doctor's office whether it has a black box warning.
- Check the package insert that comes with your medication.
- Look up the drug online—but be careful, because there is a lot of inaccurate information about drugs on the Internet. It is frustrating to note that, even on reliable government Web sites, information on black box warnings for specific drugs can be hard to find.
Try: www.fda.gov (click on "Drugs at the top left side of the home page, then type the name of the drug in the search box)...or the National Library of Medicine web page at www.nlm.nib.gov/medlineplus/druginformation.html.
If a black box drug has been prescribed for you, ask your doctor to…
- Discuss the drug's risks and benefits, taking into account the severity of the condition for which you are being treated.
- Write down the specific side effects you should watch for-subtle as well as severe.
- Provide a follow-up schedule for any appointments or tests you will need while taking the drug.
- Apprise you of any other treatment options that might be safer.
Whenever you fill a prescription…
- Always use the same pharmacy so that your pharmacist can keep track of all the medications you take. Then ask the pharmacist to make sure that any black box drug you may be prescribed is compatible with your other medications.
- Talk to the pharmacist when you get a new prescription to make doubly sure that you understand how to take the medication and know the potential side effects.
- Read the literature that comes with the medication. If you still have questions, call your doctor or pharmacist for clarification.
