What is off-label prescribing?
by N J Howell
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The FDA has known about this issue of off-labeling for a while now because they launched an investigation back in August of 2011 on the subject: "Off-Label" Use of Marketed Drugs, Biologics and Medical Devices.
Put simply, off-label prescribing means your doctor is prescribing a drug in a dosage that exceeds recommendations or is giving you a drug to treat a condition other than the condition that drug was approved to treat. I learned that it happens all the time. I also learned that there is really not a lot of accountability for off-label prescribing and that it the true affects of this practice may only now be coming to light, as more people get concerned and more investigation happens.
Update, May 2013: The latest off-label news concerns a drug calle Megace ES. Originally approved to treat weightloss from AIDS, the company that made Megace ES marketed the drug to doctors and nursing homes caring for non-geriatric patients (source: AARP newsletter). Par did this even though they were apparently aware that potential side effects included more risk of DVT, and toxic reactions in older patients who already had impaired kidney function. Par has been sued and paid millions in penalties.
What Exactly is Off-Label Prescribing?
I first read about this practice of prescribing off-label in a health newsletter from Ira Marxe over at Good Health Supplements. I like Ira. He's a no-nonsense person who cuts through the bull. This article, copyright, Ira Marxe, all rights reserved.
Use (of a prescription drug) in higher doses is known as off-label prescribing. (note from neva: it's also considered off-label prescribing if the drug is given to a patient to treat a condition it was not approved to treat). This is a dangerous practice that is common among doctors and tolerated by the FDA. Since doctors have no clinical studies to go by, what they are doing is using their patients as guinea pigs. Let's up the dosage and see what happens, and up the dosage and make more money. And now we know from the independent studies that higher dosages can cause serious harm and death and yet, doctors are still writing prescriptions of higher dosages.
If you are a user of prescription drugs you need to be aware that these are not the only drugs being used off-label. Many drugs are prescribed for diseases that had no scientific studies done and were never approved by the FDA, which is another form of off-label prescribing. For many drugs, the off-label usage far exceeds prescriptions written for what was FDA approved.
I recommend you check with your pharmacist to find out whether or not the prescriptions you are using are off-label. If they are, I recommend you confront your doctor and ask them to justify the off-label prescribing they propose or may have implemented without telling you, before you become a statistic. As I have said before, drugs do not heal, especially the drugs we are being offered today --- but nutrition does. Ira Marxe.
Continue ... more on off-label prescriptions
Want to live longer? Ira says eat healthy nutrition, live a healthy lifestyle and get regular exercise, and he should know, he's 81 years young! I agree with Ira on that. Focus on antiaging nutrition and supplementation for continued vitality into your 80's too. Ira Marxe is CEO of Good Health Supplements, home of GHS Ultra for naturally clearing clogged arteries, an Ask-a-Healer-Recommended cardiovascular health supplement.
Health Disclaimer: It is not my intention to cause panic or fear with this information on off-label prescribing but to educate. Talk with your pharmacists; talk with your doctor; investigate this health question online. It's your life and you can take charge of it. You earn the right to ask these questions when you pay your doctor bill so take advantage of your healthcare rights.