The Dangers of Off-Label Drug Use

The practice of off-label prescribing is common and legal. In fact, an estimated one of every five prescriptions is written for off-label use.

In simple terms, off-label prescribing refers to when a doctor prescribes a medication that the FDA has approved to treat a condition that is different than that of your condition. The FDA, under Federal law, must approve all new prescription drugs using evidence that the medication is safe and effective for that particular condition. The catch, though, is the drug maker, unlike a physician, is not permitted to market an approved drug for other purposes.

Beta-blockers, for instance, are an example of beneficial off-label prescribing. This class of medications are FDA-approved for the treatment of high blood pressure but these same drugs are widely used for patients with heart failure. In some cases, off-label use can get approved by the FDA eventually.

Off-Label Debate

Although doctors agree that off-label prescribing does have its place, they also admit that the use of off-label drug use can increase the risk of lawsuits if a patient experiences unwanted or bad side effects.

In 2012 alone, the U.S. government won more than $5 billion in settlements with drug companies accused of illegal promotion, including a $3-billion settlement with GlaxoSmithKline.

Investigators alleged Glaxo marketed the off-label benefits of several drugs, including the company’s brand-name version of ondansetron. The company told the Star that as part of the settlement it admitted no wrongdoing “in connection with physician prescribing of ondansetron in the U.S.”

Several companies prosecuted for illegally marketing unapproved uses in the U.S. are selling the same products in Canada.

In a recent case, a girl, 15, was given the antibiotic minocycline to clear her acne. Only she developed lupus-like symptoms – causing her immune system to attack her own tissues and organs – and she died. The drug was not approved by Health Canada. This is one story of many. An ongoing investigation by Star found Health Canada is aware of these situations but doesn’t reveal to the public the serious, often, fatal side-effects that are suspected by off-label prescriptions.

The Star’s analysis revealed nearly 400 cases from 2010 to 2013 that involve a wide and disturbing range of reported side-effects: deaths, heart attacks, strokes, birth defects, organ failures and “spontaneous” abortions.

Despite repeated requests, Health Canada has not provided any evidence it has ever investigated, prosecuted or fined a single drug company for off-label promotions, ever. The Canadian government should consult U.S. investigators as well as lawyers that have prosecuted companies stateside for off-label promotion of drugs.

“The Canadians,  can use the U.S. prosecutions as a roadmap to investigate these same companies and the drugs that they also sell in Canada,” said American product liability lawyer Stephen Sheller.