You probably have experienced having been prescribed by your doctor with drugs that have approved and investigational off-label uses. There could be confusion on your part especially when you know that a specific drug treats ailments other than your illness. It would be advisable if you would fully understand how and why some medications are prescribed for sicknesses other than stated in the product labels.
In the US and in many other countries, new drugs are subjected to three-phase clinical trials before they are rendered approval to be used by consumers. Such research studies are performed to prove that those drugs are actually effective in treating identified ailments or medical conditions. The trials are also aimed at proving that the medications are actually working as they are supposed to and that they are safe when taken as directed.
Health regulators like the US Food and Drug Administration work with manufacturers in creating labels for new drugs. Though such drug label is not the actual label that you see on containers distributed in the market, that special label reflects the report and the information based on clinical trials. Such a special report is made available to doctors and other health professionals who take part in dispensing and prescribing the drugs. That label is also the basis for the actual product label that comes with product containers and boxes.
It is possible that a particular drug is able to treat an ailment or medical condition other than what it is disclosed in the product label. When a medication is prescribed for a different disease or health problem, in a different dose compared to the approved label, or in a different administration, the drug is said to be in an ‘off-label’ use. Thus, an off-label use of a drug is also referred to as unapproved or non-approved use of that medication.
Investigational and off-label uses for Ultram
Ultram is a popular prescription pain reliever. It is not surprising that to date, the drug is subject to numerous investigational and off-label uses, aside from its approved medical purpose. It is not yet clear whether its maker, Janssen Ortho LLC, is already facilitating trials to test the potential uses of the medicine in treating other ailments or conditions.
But according to independent researchers, there is several proven effectiveness of the pain reliever other than its approved use. Many doctors are now prescribing the medicine to possibly treat other conditions like diabetic neuropathy, fibromyalgia, opiate withdrawal symptoms, obsessive-compulsive disorder, migraine, restless legs syndrome, and postherpetic neuralgia. Interestingly, some doctors are even prescribing Ultram for premature ejaculation.
No regulatory approval is yet awarded for Ultram in treating those off-label conditions. But doctors are left with their discretions in prescribing them. Their insights are usually based on independent studies and clinical trials performed by researchers and published in medicine journals.
Possible problems from off-label drug use
The main problem encountered with off-label use of drugs is involving medical reimbursements especially from health insurances. Most insurers today still do not cover expensive medications that are used in ways other than what they are approved for and what are listed in the drug labels. Many insurance policies do not cover investigational and experimental drugs. Approved drugs could fall into the investigational category when used other than approved for or stated in the product label.
Thus, you may have a hard time reimbursing expenses if you have bought Ultram as prescribed for an ailment or health condition other than severe pain. Some insurers are more considerate when it comes to some cases. But you could never be sure whether your health insurance company is among those considerate institutions. If your reimbursement application is declined, you may not be able to do something about it but wait until Ultram is approved for other uses other than pain relief.
There is also a possible legal risk. This happens when the patient experiences bad or unwanted outcome or side effects from the off-label use of Ultram. There are issues about treatments’ standard of care that are raised by the use of medications off-label. Not all patients are open to try off-label uses of drugs because of lack of information. This practice often creates doubts and taints in relationships between patients and their doctors.
As a final reminder, do not use Ultram off-label without direct assistance and guidance from your doctor. It could be considered as self-medication. Leave it to your doctors to make the necessary prescriptions whether those are off-label or not. They know that they are doing and they know how to keep your overall health safety.