Dangers & Advantages of Off-Label Drugs
NGUYEN: Has the rapid pace of medical discovery caused your doctor to get ahead of the FDA? It's not unusual for physicians to prescribe medications' different uses not specifically approved by the FDA. Should be concerned? Well, joining us from Sacramento is Dr. Bill Lloyd, a surgeon and pathologist to tell us more about off-label medications. Good morning and thanks for being here.</s>DR. BILL LLOYD, SURGEON: Good morning, Betty.</s>NGUYEN: Let's talk about these off-label medications. There are so many different types of medications out there. Why are doctors prescribing them off-label?</s>LLOYD: Well, Betty, there are lots of medications. Here's a familiar drug insert that comes from one of the most commonly prescribed children's asthma medications, but yet in the small type it says: "the safety and effectiveness of this medication has not proven in young children." There's one reason why doctors have to prescribe off-label, because the drugs haven't been tested in children but yet the children need the medication...</s>NGUYEN: But if they haven't been tested, is it dangerous, don't doctors know this?</s>LLOYD: The drugs themselves are approved. So this is...</s>NGUYEN: But for children -- if it hasn't been tested for children, and they're prescribing them for children, isn't there a red light going up, saying, this could be dangerous?</s>LLOYD: Well, in fact it's unethical to test drugs in children. It's unethical to test because young children can't give their consent. So what doctors have to do is figure out, this works for adults, we'll adjust it somewhat for children.</s>NGUYEN: I see what you're saying. OK. Well. off-label prescriptions, is it illegal?</s>LLOYD: It's not illegal, in fact, it's common practice. There are lots of reasons why doctors are going to prescribe off-label use of medications. If it's a rare condition for example. If there's nothing else we can offer the patient, we might as well try something that's off-label. If it's life-threatening situation, if there's a consideration of drug resistance, specifically for antibiotics, for unproven dosages of medication as well, if a patient has a poor response to a medication or if they are unable to wait for the FDA to respond in five or seven years to prove the safety of a given medication and the patient needs it now, the doctor is going to consider off-label use.</s>NGUYEN: But would you consider it dangerous, because a lot of these medications, like we say, are not being used for the purpose that it was intended. Yet sometimes it can be beneficial. For example, aspirin, a lot of doctors like to say, take an aspirin a day, it will help people with heart problems.</s>LLOYD: Well, it's a wonderful point. Doctors have to exercise sound judgment. About the aspirin, 20 years ago, doctors discovered a relationship between aspirin and heart disease. But it wasn't until 1998 when the FDA finally came around and said, hey, if you take an aspirin, it might protect you from having a heart attack. You know, there is a sedative that can help protect you from leprosy. There are seizure medications that can help with chronic pain relief. So there are many different uses for medications that researchers and clinicians share in the medical literature. And if doctors exercise sound judgment, understand what the drug can do for a patient, are aware of the possible risks and benefits, then it's perfectly fine to consider the use of off-label medication.</s>NGUYEN: Dr. Lloyd, if a patient is receiving a medication which is off-label from their doctor, that of course is sparking a red flag. What should they do?</s>LLOYD: Well, you might consider it like any other form of treatment. And that means ask lots of questions. Why are we taking this drug? Try to get an understanding of the disease. Why am I being prescribed this and how specifically will this drug work? Know the potential risks. Your doctor should be able to explain very clearly how this medication works and how it works with other medications you may already be taking. Don't be afraid to do your own research. You can go to the library and get a copy of that big book, the PDR, or go around the corner, ask another doctor or perhaps ask a local pharmacist about the medication the doctor is considering for you off-label.</s>NGUYEN: Dr. Bill Lloyd, surgeon and professor at the University of Texas Health Science Center. Thank you.</s>LLOYD: Thank you, Betty.</s>NGUYEN: Messages home to an unlikely group of recipients. How these first graders are learning about the war in Afghanistan. And an American dream. Why the Sprys should visit your hometown. We'll have your responses to our e-mail question when CNN SUNDAY MORNING continues.