“Newer” drugs not necessarily “better and safer” drugs, despite progress in drug safety
Adverse drug reactions remain one of the top 10 leading causes of death in Canada
Ottawa (October 13, 2010) –Despite extensive measures to ensure drug safety, adverse drug reactions remain one of the top 10 leading causes of death in Canada. The reasons for this are explored in the latest instalment of the Mythbusters series published today by the Canadian Health Services Research Foundation (CHSRF) entitled “Myth: If a drug makes it to market, it’s safe for everyone.” Adverse drug reactions cover a wide array of unintended effects—from dizziness to stomach irritation to serious illness or even death.
Here are some of the major limitations to drug safety measures:
- Clinical drug trials often do not test new drugs on individuals who are elderly, young, pregnant or ill. Consequently, risk of developing an adverse reaction among these groups often remains unknown when the drug goes to market.
- Drugs are usually tested only for their intended use; however, in certain circumstances doctors may prescribe “off-label” or outside of clinical guidelines.
- The current system of drug safety monitoring relies heavily on voluntary reporting of adverse drug reactions by individuals or health professionals (however, drug companies are required to report adverse drug reactions to the government).
Newly approved drugs have a one in five chance of receiving a “black box warning” (for having serious side effects) from the U.S. Food and Drug Administration or being withdrawn from the market within 25 years of approval (half of all withdrawals occur within two years of approval).
“Roughly 90 to 95% of new drugs provide no substantial advantage over ones we already have and typically have not been tested on enough people to identify all important side effects,” said James McCormack, a professor in the Faculty of Pharmaceutical Sciences at the University of British Columbia. “Healthcare professionals may be best to avoid prescribing a new drug until it’s been on the market for at least two to three years—especially if the condition isn’t severe,” he added.
The Drug Safety and Effectiveness Network established by the Canadian government in 2007 is a positive step. The key objectives of the network are to increase the available evidence on drug safety and effectiveness available to regulators, policy-makers, healthcare providers and patients and to increase capacity within Canada to undertake high-quality research after drugs have reached the market.
“It is ultimately up to individuals and families to make decisions about drugs with a health professional,” stated Maureen O’Neil, President of CHSRF. “Patients need to fully understand the possible benefits and harms of any drug in order to make an informed decision,” she added.
This issue of Mythbusters is based on a submission by the 2010 Mythbusters Award recipient, Ms. Tenneille Loo. Ms. Loo is a master’s candidate at the University of British Columbia. For more on the 2011 Mythbusters Award competition currently underway, please visit the CHSRF website.
The Canadian Health Services Research Foundation is an independent, not-for-profit corporation with a mandate to promote the use of evidence to strengthen the delivery of health services that improve the health of Canadians. CHSRF is funded through an agreement with the Government of Canada.
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