Health Canada's fast-tracked drug approvals can put public at risk

Drugs streamed into Health Canada's accelerated review process are more likely to be withdrawn from the market or earn a serious safety warning than those that undergo the standard review, according to a recent paper out of York University.

The study, published online by the on Oct. 8, is the first of its kind undertaken in Canada. It tracked a total of 434 new active substances (NASs) approved by Health Canada between 1995 and 2010, examining how many subsequently acquired either serious or had to be withdrawn from the market for safety reasons. The NASs were then compared to see whether a difference in safety existed between those that had gone through Health Canada's standard 300 day review period vs. the 180 day priority process.

"I found that drugs that went through the standard process had a 1 in 5 chance of either having a serious safety warning issued or being withdrawn from the market for being unsafe," says study author Dr. Joel Lexchin, Professor in York's Faculty of Health. "However, if the drug goes through the priority process, it has a greater than 1 in 3 chance of having the same outcome."

Though some drugs are moved into the priority process because they provide major therapeutic advances for serious illnesses, such as cancer, /AIDS, and , and thus may be put through with a lower benefit to harm safety ratio, Lexchin found that the types of drugs in the priority category, and the types of diseases they treated, did not account for the difference in safety issues.

"Even drugs that provided no major therapeutic advances were still more likely to acquire serious safety issues if they were put through the priority review," says Lexchin. "This indicates that the difference is likely due to the faster review missing serious safety issues."

The study concludes that new products that offer major therapeutic advantages should be embraced, even with the significant gaps that exist about their safety, but because most NASs do not fall into this category, clinicians and patients should be using these drugs very cautiously.

add to favorites email to friend print save as pdf

Related Stories

Heart safety of non-heart drugs questioned

Dec 29, 2007

A New York heart surgeon is calling for more testing to ensure the cardiovascular safety of drugs developed primarily for non-cardiovascular medical problems.

In drug-approval race, US FDA ahead of Canada, Europe

May 16, 2012

The U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe, according to a new study by Yale School of Medicine researchers. The study counters ...

Drugs warning -- check the label

Feb 02, 2011

A new study highlights inconsistencies in black box warnings - medication-related safety warnings on a drug's label - and argues for a more transparent and systematic approach to ensure these warnings are consistent across ...

Recommended for you

Physicians warned about counterfeit medical devices

5 minutes ago

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

Zydelig approved for three types of blood cancer

37 minutes ago

(HealthDay)—Zydelig (idelalisib) has been approved by the U.S. Food and Drug Administration to treat relapsed forms of blood cancer, including chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL) ...

Journal raises concern about blood-thinning drug

13 hours ago

A medical journal raised concerns Wednesday about a blood-thinning drug widely used by people at risk of stroke, accusing its manufacturer of concealing safety data and regulators of laxness.

Supermaterial gives rejected drugs a new chance

Jul 22, 2014

More than 80 percent of all drug candidates in the pharma R&D suffer from poor solubility and are therefore rejected early in the drug discovery process. Now Uppsala University researchers show that the new ...

User comments