Obesity is a health condition that can cause diabetes, heart disease, and high cholesterol levels. For most people, their solution to lose weight involves changes in diet and exercise habits. However, lifestyle changes may not be effective for some people, so they prefer to take medication for long-term weight management.

Topiramate for Weight Loss: Is It Safe To Take Off-Label Prescription Drugs?
(Photo: Pexels/ Pavel Danilyuk)

There are currently several medicines that the FDA approves for weight loss. Some drugs are used off-label, which means they may help people lose weight even if the FDA does not approve them. One of them is the drug known as topiramate.

What is Topiramate?

Topiramate is a drug developed for treating seizures in adults and children and for reducing migraine headaches in people 12 years old and above. Currently, seizures and migraines are the only health conditions with FDA-approved uses for topiramate.

This drug is designed to stop seizures during its initial phase by preventing the brain cells from working much faster than usual. In 1996, the FDA granted approval for topiramate for the treatment of various forms of epilepsy. After six years, the agency added migraine headaches prevention to its list of approved use for topiramate. This medication does not relieve migraine pain after it starts occurring, but experts believe it reduces migraine frequency by calming the overactive pain signal in the nerve cells.

As topiramate effectively treats seizures and migraine, it also comes with some side effects, which include weight loss. Because of this, it has been used by some people to control binge eating and to shed excess body weight, although FDA does not approve this. In combination with phentermine, topiramate is the main ingredient in Qsymia which FDA approved for weight loss.

In a 2013 study published in the National Library of Medicine, a group of researchers she has studied the impact of topiramate on weight reduction in patients who suffer from type 2 diabetes. A 32-week clinical trial study was conducted from 2008 to 2010 on 69 subjects. It was found that the treatment groups who were given topiramate showed significant changes in mean body mass index (BMI). This means that topiramate effectively induces weight loss and improves glycemic control in diabetic and obese patients.

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Are Off-Label Prescription Drugs Safe?

During a doctor's appointment, a patient may receive a prescription for medication that may not be approved for their specific condition or age group. This practice is called "off-label" prescribing, where the medication is being used in a way not specified in the FDA-approved packaging label.

If the FDA approves a drug, the doctors can prescribe it to their patients. However, doctors are also allowed to prescribe drugs for other uses if they feel it will benefit the patient.

Giving off-label prescriptions is entirely legal and common. In the U.S., one in five outpatient prescriptions written is intended for off-label therapies. According to WebMD, off-label prescribing can be beneficial, especially when the patient has tried all the other approved options, such as for rare diseases or cancer.

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