Toronto Star has published a list of 151 prescription drugs undergoing safety investigations in 2o13. The Star obtained the information only after persistently bugging officials at Health Canada.
With a remarkable example of doublespeak, up till now Canada’s drug safety authority though the best way to keep us safe was to keep this information secret from both the individuals who put these drugs in their bodies and from the Doctors who prescribe them.
Quite why Health Canada ever thought this was their role is yours to guess and ask. Maybe they reasoned that the mass panic ensuing from making the information available would cause us all to ask for motte drugs in such a rush that Docs would run out of prescription pads.
Congratulations to The Star team working on this and also to Health Canada for living up to their name and making available important information information like this so that individuals and their Doctors can have the information they need to make better informed choices about using drugs.
“There is no compelling argument to be made against transparency when clinical decisions and patient safety hang in the balance,”
-Dr. Juurlink, Sunnybrook.
You’ll find many prescription medications on the list – including the commonly prescribed ones. if you take meds then you might find one of your meds on the list.
Note– Just because a drug is on the list and under investigation does not mean it’s more dangerous than one that isn’t . It does, though, mean it’s a good idea you find out more about the drugs you take and talking with your Doc about what it means for you.
Why not take a copy of the list to your Doc or other workers next time you see them?http://www.scribd.com/doc/217732071/Drug-Safety-Reviews
You can also get a report that lists adverse reactions reported for each of the drugs you take from RxISK.com
Star obtains list of red-flagged drugs
By: Diana Zlomislic News reporter, Published on Sat Apr 12 2014
Doctors and health experts alarmed that Health Canada won’t make public its reviews of drug investigations in 2013.
Quetiapine, known by the brand name Seroquel, is the top-selling, most prescribed antipsychotic in Canada, ringing in sales last year exceeding $200 million. Indicated to treat schizophrenia and bipolar disorder, researchers say the spending figures suggest the drug is still being used widely off-label to sedate elderly patients with dementia despite warnings against this practice.
Top-selling antidepressants, sleep aids and diabetes drugs are among 151 secret safety reviews of medications completed by Health Canada last year, the Toronto Star has learned.
The Star obtained a list of last year’s federal drug reviews that likely won’t see the light of day despite Ottawa’s new commitment to transparency. It took repeated requests made over five months to access the index. No public record of this work has existed until now.
The Star shared this list with half a dozen doctors at hospitals and respected drug safety and health policy researchers, all of whom were troubled that Health Canada has no plans to publish reviews associated with many high-profile medications.
The index includes reviews of brand-name pills like Seroquel, an antipsychotic. Intended primarily for the treatment of schizophrenia and bipolar disorders, it accounts for more than 40 per cent of prescriptions in its drug class, with sales exceeding $200 million annually (a figure that suggests it’s frequently used outside its approved purpose). Also scrutinized were asthma inhalers (Alvesco and Qvar), painkillers (Tridural and Tramacet) and the smoking-cessation drug Champix, which reportedly was linked to suicides in some users though Health Canada ruled last year that the drug’s benefits continue to outweigh its risks.
The federal index also shows government officials had cause to investigate entire classes of drugs, including ones used to treat cancer, anxiety and severe mental health disorders though exactly what Health Canada found in these reviews is largely a mystery.
In many cases, doctors who prescribe these drugs and the Canadians who take them have no idea the medications were even under investigation, red-flagged because of concerns raised by regulators in other countries or because of worrisome side effects detected during Ottawa’s routine monitoring.
“Millions of people take these drugs,” said Dr. David Juurlink, a physician at Sunnybrook Hospital and a former pharmacist. “These drugs harm people and in some instances they kill people. Frankly, shame on them for even contemplating not publishing them.”
A medication called Keppra, used for seizures in adults and children, was reviewed by Health Canada three times last year yet the federal online database that physicians and patients rely on for details about adverse drug reactions and recalls includes no mention of it at all. A more general search of the federal website reveals the product monograph was updated in September 2013 to include a “brand safety update” for “drug interactions” but there is no additional information.
Health Canada’s new plan to be less secretive comes with a few catches.
Only a fraction of all drug reviews completed by Health Canada will be publicly released. Those that are shareable will appear on the department’s website in summary form. While full reviews of summary reports will be available for the asking from Health Canada’s Marketed Health Products Directorate, portions of those documents may be blacked out to protect confidential business information from manufacturers or other regulators. And reviews will be released only on a “forward-going basis.” Assessments completed before 2014 will be shared only if there is a great public interest. Problem is, Canadians have virtually no way of knowing what assessments are worth fighting to make public.
“It’s just really an issue about the amount of resources it takes to put together these summaries and to make them available,” federal Health Minister Rona Ambrose told the Star, explaining why drug reviews completed before 2014 are not part of the transparency plan.
During a stop in Toronto earlier this week to visit St. Joseph’s Health Center, Ambrose told the Star she was unaware that an annual list of drug reviews completed by Health Canada wasn’t publicly available.
“We will look into that,” she said. “If the lists are not available, I will ask the department why that is the case. The commitment they’ve made to me is to support this level of transparency. We will continue to endeavour to be more and more transparent. We want to hear feedback from people,” she said.
“There is no compelling argument to be made against transparency when clinical decisions and patient safety hang in the balance,” said Dr. Juurlink of Sunnybrook.
“I can see how redacting and summarizing information from these reports could get expensive but that is money Health Canada should be spending,” said Dr. Joel Lexchin, an emergency physician with University Health Network in Toronto and a professor in the School of Health Policy and Management at York University.
The government’s first public release of a drug review — a summary report for Diane-35 posted online earlier this week — is an exception. A review for the controversial acne pill, widely used off label for birth control, was completed last week.
Ambrose made the promise to begin releasing drug review reports four days after the Star published its first investigation into Diane-35 last October, featuring the case of first-year University of Calgary student Marit McKenzie, 18, who died suddenly in January 2013 from complications caused by a massive blood clot. A hospital pharmacist suspected Diane-35.
McKenzie was the 13th young Canadian women whose death was linked to the drug according to adverse reaction reports filed with the federal regulator, though the associations have not been proven. Health Canada refused to publish its safety review of Diane-35 despite requests from the Star and the family to do so.
It’s no secret that one of the 10 most-prescribed classes of medications in Canada has some issues.
Benzodiazepines, often called “benzos,” are a sedative-hypnotic group of drugs that treat anxiety and insomnia.
“They’re always on a watch list of drugs you should look out for for potentially inappropriate use,” said Steve Morgan, a University of British Columbia health economist who co-authors the Canadian Rx Atlas, an online compendium that analyses drug use and spending for more than 10,000 medications using data supplied by health-care market research company IMS Brogan.
Canadian doctors wrote more than 20 million prescriptions for benzos last year. Sixty-three per cent of the $336 million spent on these drugs in 2012-2013 was attributed to female patients. Bestselling generics include lorazepam, zopiclone and oxazepam.
“Long-term use carries significant risk of addiction, dizziness and falls,” Morgan said. “It becomes difficult to wean patients off. They’re a problematic drug class.”
Also re-evaluated in 2013 for unclear reasons is an entire group of cancer drugs known as Vascular Endothelial Growth Factor Inhibitors.
They prevent the growth of blood vessels that supply the tumour with nutrients to grow.
The most commonly used drugs assessed in that category are bevacizumab (for colorectal cancer, brain cancer, cervical cancer) and sunitinib (for renal cell cancer, pancreatic cancer, sarcoma), a spokeswoman for BC Cancer Care told the Star. She said the agency was not aware of any specific safety reviews completed by Health Canada.
In the case of sunitinib, Health Canada issued an advisory last September warning that the drug could cause “severe and sometimes life-threatening skin rashes.”
Health Canada conducts several types of drug reviews. The largest category is routine monitoring that relies on “proprietary” information provided by manufacturers about adverse reactions, usage data and risk-management plans. In 2013, the federal health department reviewed 128 drugs in this way.
Dr. Supriya Sharma, a senior medical adviser with Health Canada, told the Star that this group of reviews is exempt from public release unless officials find something alarming that prompts a more comprehensive safety review.
These routine reviews are just point-in-time snapshots of a drug’s performance on the market, Sharma said, and Health Canada worries the information could be taken out of context.
“This argument about information being taken out of context can be used to justify withholding almost anything,” said Lexchin. “If Health Canada is worried about that, they can contextualize the information by pointing out what its limits are.”
The names of 47 of the 128 drugs subject to routine reviews last year were withheld entirely from the list provided to the Star because these drugs are awaiting approval and Health Canada has agreed not to identify them.
This is also a problem, Lexchin said. “Some of these drugs they’re considering for approval are similar to things that are already on the market that have problems. Some of them may be drugs that they’ve previously rejected and now are reconsidering again. Why are they doing that? What’s changed? There are a number of reasons for wanting to know what they’re thinking about.”
Drug safety researchers and doctors say it’s unreasonable to expect that federal health officials can spot every early sign of trouble all on their own. While some of the drugs on last year’s routine-monitoring list included well-known entities like Avandia — once the world’s bestselling treatment for Type 2 diabetes before it was removed from the European market in 2010 over concerns about its potential to cause heart and strokes — a number of the medications are new to the market.
For this latter group in particular, a second-set of eyes on emerging data is critical, said Lexchin.
“Based on the work I’ve done, the most dangerous period for new drugs is within the first three years,” said Lexchin, who has been published extensively in peer-reviewed journals on the topics of drug safety and prescribing practices. “Anything that’s been on the market three years or less, we should get as much safety information as there is.
“They’re not going to catch everything. Some of these issues around how well drugs work or how safe they are involves interpretation. We need to be able to know what’s going on to be sure Health Canada is making appropriate decisions.”
A case in point: Long before Vioxx came under public scrutiny, a critical, secondary review of published FDA data on the painkiller warned about dangerous side effects, including severe heart problems. This assessment was carried out by researchers at University of British Columbia’s Therapeutics Initiative. Three years after Vioxx hit the market, their work revealed evidence of an increase in heart attacks and other serious side effects associated with the drug. As a result, British Columbia’s Ministry of Health decided not to fund the drug. Two years later, Vioxx was suspected of causing tens of thousands of fatalities across North America. The independent review of Vioxx is credited with saving more than 500 lives in British Columbia.
The list of drugs under investigation in 2013, compiled by Health Canada can be found here…