Healthy Skepticism Library item: 10211

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

Sharp increase in children hurt by prescription drugs
CBC News 2004 Feb 17
http://www.cbc.ca/news/story/2004/02/17/drug_reaction040217.html

Full text:

The number of Canadian children harmed by suspected prescription drug reactions has tripled in the last five years, CBC News has learned.

CBC obtained the database Health Canada uses to track suspected adverse drug reactions. It shows about 500 reports of children who had what are suspected to be adverse drug reactions in the last year.

The percentage of reported reactions considered serious – causing hospitalization, disability or even death – has tripled since 1997.

Doctors are prescribing more SSRI (Selective Serotonin Reuptake Inhibitor) anti-depressants for children. But the CBC analysis suggests that only accounts for a small percentage of the increase in reported serious drug reactions.

Dr. Supriya Sharma, with Health Canada’s marketed products directorate, appeared unaware of the trend.

“Hopefully, some of that is actually because we’re stimulating reporting and people are more aware of the system,” said Sharma.

“Again, we would really have to take a look at the numbers and see what does that mean in terms of trends.”

At the request of CBC, a former biostatistician with the U.S. Food and Drug Administration analyzed Health Canada’s database. Michael Elashoff concluded that Canada’s early warning system for tracking drugs that harm is a blunt tool.

“I think the quality of the database is indicative of fairly sloppy record keeping and in general indicates a general lack of anyone particularly caring about the quality of the database,” said Elashoff.

Doctors and nurses report fewer than one in 10 suspected adverse reactions to Health Canada. Those who study adverse reactions say the department is lacking staff and funding to effectively analyze the data they receive.

“Right now the average Canadian citizen – if they have a lot of confidence in the adverse reaction system – it’s misplaced because it’s not a system that’s necessarily timely or to pick up things people need to know as soon as possible,” said Dr. Michael Reider, who runs a pediatric adverse drug reaction clinic at the University of Western Ontario.

Reider says because most drugs aren’t studied for use in children, tracking adverse reactions is an important way of finding which drugs may be dangerous for them.