Healthy Skepticism Library item: 12805

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Off-label drugs
CBC News 2008 Jan 23
http://www.cbc.ca/news/background/health/off-label-drugs.html

Full text:

You’re feeling something coming on so you head off to the doctor and get a prescription. A pill designed to take care of what’s ailing you.

But sometimes medical science discovers that drugs designed to treat one condition are actually much better at treating another.

Take Viagra. Millions of men do. It was originally developed and approved to treat angina. But it quickly became apparent that the drug’s real strengths lay well south of the heart.

Doctors began prescribing it off-label while Pfizer, the company that developed the drug, applied to have it approved as the first drug to treat erectile dysfunction.

What is off-label drug use?
Health Canada regulates all drugs sold in Canada. Before they are approved, drugs manufactured and sold in this country must go through a regulatory process to ensure their quality, safety and effectiveness.

When a doctor prescribes a drug for a use for which that drug has not yet been approved by Health Canada, that’s considered off-label use.

If a drug company wants to market a drug as a treatment for something other than for what it was originally approved, it must go through the regulatory process again. That can take years.

Is off-label use allowed?
Yes. Physicians are allowed to prescribe any medication they believe will help their patients, even if the drug has not been approved as a treatment for a particular condition. The Canadian Medical Association has no policy on off-label drug use by physicians. Doctors use their own medical discretion based on scientific evidence.

But even the doctor might not know that the medication has not been approved for use for a particular condition. Drug companies don’t have to tell doctors that they asked Health Canada to approve a drug for another use but were turned down.

It’s estimated that up to a third of all prescriptions written are for off-label use.

How do physicians decide if a drug will be effective for conditions other than those approved by Health Canada?
Physicians generally rely on publications like medical journals, reports and peer- reviewed studies for this information. The decision to prescribe a drug off-label is usually based on a review of scientific studies of the drug for different indications.

Why would a drug be used off-label?
Some physicians prescribe a drug off-label as a last resort. In other cases, the scientific evidence that the drug may be effective for other conditions is so strong and overwhelming that the drug is routinely prescribed for that indication even though it has not yet been approved for that use.

How do I know if I’m on an off-label prescription?
Your doctor does not have to tell you that the drug you are getting has not yet been approved for your particular condition. However, most of them will tell you if they are prescribing off-label. So, if you’re not sure, ask your doctor.

Can drug companies market drugs for off-label use?
No, they can’t promote a drug for a use that isn’t stated on the Product Monograph.

Section 9 (1) of the Food and Drugs Act deals with false, misleading advertising and Section C.08.002 of the regulations states: “No person shall sell or advertise a new drug unless the manufacturer has filed a New Drug Submission and received a Notice of Compliance because the terms of such authorization haven’t yet been established and the proposed indications for use have not been verified.”

Health Canada has a policy that explains the distinction between advertising and non-promotional activities. It allows the drug company to report scientific studies about unapproved uses for the drug and also allows the company to issue press releases about those scientific studies. There are guidelines about what can be reported in the press release.

What are some other examples of drugs prescribed off-label?
Lucentis shows promise in treating age-related macular degeneration (AMD), a disease that leads to blindness. But it’s very expensive. However, ophthalmologists have been prescribing Avastin, a drug developed to treat colon cancer, for patients with AMD. Both drugs are made by the same company, Genentech.

Avastin is much cheaper than Lucentis. Genentech has not tested Avastin for AMD and has not asked Health Canada to approve it for that use.

Other examples include prescribing:

Anti-seizure drugs for pain management.
Nonsteroidal anti-inflammatories for nonarthritic pain.
Tricyclic antidepressants for migraine relief.
Anti-psychotics to manage elderly patients with dementia.
Are there drawbacks to using medications off-label?
There can be. Health Canada does not monitor the off-label use of drugs. Several coroners’ juries have recommended the department should.

Health Canada maintains that the rules about product monographs are pretty clear: if a drug should not be used under certain conditions, it must be noted.

On occasion, Health Canada will post warnings or advisories about certain drugs that may be prescribed for uses other than what they were approved for.