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Off Label Prescribing of Prescription Medication
Coleman Legal LLP
Sep 21, 2015

Off Label Prescribing of Prescription Medication

Medication is prescribed on a daily basis, in every GP surgery, every pharmacy in routine fashion. However, what patients may not be aware of, is the practice of ‘off label prescriptions’’, whereby a medication is prescribed that may not have been approved for a patient’s specific condition or age group.

The term ‘off label prescribing’ means medication is being used in a manner that is not specified in MHRA (Medicines and Healthcare products Regulatory Agency) approved packaging labels. It is a much more common practice than one may have thought. Doctors are not required to tell a patient that a drug is being prescribed ‘off label’.

Off-label use of medications and other products has been an accepted practice for many years. For example, Botox was first approved in December 1989 by the Food and Drug Administration (FDA) to treat Blepharospasm and Strabismus and in December 2000 to treat cervical dystonia. On April 15, 2002, the FDA approved Botox to treat frown lines; however, this has been a widely accepted off-label use for cosmetic purposes for almost 10 years.

An example of a common prescription which may have non-preferred side-effects is the use of statins such as Lipidol, which is a well-established first line agents for cholesterol-lowering in cardiovascular disease.

Lipidol is generally well tolerated and presents with few side effects. However when rarer side-effects such as headaches, gastrointestinal issues and bloody urine occur, concerns are then raised.

Side-effects to Lipidol may be dose-related or associated with other drug interactions.

Most individuals on statins are ‘high risk’ patients anyway and tend to be on multiple agents for cardiovascular disease which may interact with their statin.

If progressive muscle symptoms are ignored (which may be a side-effect of taking this prescription), sadly fatalities can occur.

When prescribing statins such as Lipidol, physicians should be aware of and alert to potential risks, and educate patients to report any potentially significant symptoms.

There have been previous instances whereby ‘off labeling’ has had dramatic and damaging results. “Off-label prescribing can expose patients to risky and ineffective treatments,” medical ethics professor Rebecca Dresser and Joel Frader, MD, writes in the Autumn 2009 issue of The Journal of Law, Medicine & Ethics.

Fen-Phen is one of the best examples of off-label use with a poor outcome. The FDA approved medications fenfluramine hydrochloride and phentermine hydrocholoride as individual, short-term treatments for obesity. But doctors eventually began prescribing the two drugs together after an article describing the cocktail’s dramatic weight loss effects appeared in a medical journal and numerous mainstream publications.

That off-label drug combination had devastating results: Many patients ended up with severe, and potentially deadly, heart valve damage, an outcome that triggered a multi-billion dollar lawsuit. In 1997, the FDA ordered Fen-Phen off the market.

While off-label uses can give doctors the flexibility they need to best treat their patients, off-label uses also come with serious risks. Used off-label, drugs may have serious side effects. For example, Risperdal is a popular antipsychotic drug. In recent years, doctors have started prescribing it to children as an ADHD treatment, despite the fact that Risperdal is not approved by the FDA/MHRA for use in children. Unfortunately, children treated with Risperdal are at risk for a number of serious side effects. One such side effect is gynecomastia, a permanent enlargement of the breast tissue in males – it can only be treated with surgery. Another common example of off-label drug use is testosterone replacement therapy for the treatment of age-related decreases in testosterone. Testosterone replacement therapies haven’t been approved for that use, but doctors are prescribing it. In fact, the FDA has issued a warning that use of testosterone replacement therapy seriously increases the risk of heart attack, stroke, and death. As a result of the testosterone replacement therapy, thousands of men have suffered heart attacks and strokes and are now filing suit against the makers of the drugs.

However, ‘off-labeling’ is not an entirely bad practice. In fact it can be beneficial , especially whenever patients have exhausted all other possible options. Off-label drugs are most frequently used to help two categories of patient: children (due to the difficulty in undertaking clinical trials with children), and people with cancer (whenever the terminal nature of the illness means that any potential life-extending benefit is likely to outweigh the chance of risk from the drug being given). Something to be conscious of is to keep your GP/physician regularly informed of symptoms or conditions that you are presenting with, in order for appropriate prescriptions to be administered.

If you feel that you have been mis-prescribed medication or that you have been the victim of medical negligence, firstly contact your General Physician and then you can contact medical negligence solicitors to see how you can vindicate your rights.

Keith Rolls Partner Coleman Legal LLP

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