Health Canada takes baby steps toward drug safety

DRUG BUST Alan Cassels

If you thought we could get through these lazy days of summer without another major drug warning from Health Canada for a class of drugs taken by thousands of Canadians, think again.

The most recent advisory is among the more mystifying of the “adverse drug reactions” warnings I’ve seen lately; it warns of tendonitis and even tendon rupture linked to a commonly prescribed, relatively new class of antibiotics. And while the warning threatens to make me riff, for the umpteenth time, on the variety of ways in which drug regulators around the world – Health Canada not excepted – seem to go through the motions of monitoring and ensuring drug safety, there was also some good news. In a separate announcement, Health Canada advised it would provide some new seed money to help establish a drug safety research network in Canada.

This is very good news, but first, about the warning. The fluoroquinolone antibiotics, which include ciprofloxacin (Cipro) and other drugs whose generic names end in floxacin, have been under a dark cloud for a while now. More than two years ago, the drug watchdog group Public Citizen petitioned the US FDA to strengthen the warnings, stating, “…tendon ruptures associated with these drugs continue to occur at a disturbing rate, but could be prevented if doctors and patients were more aware of early warning signals.”

Last month, Health Canada was seemingly spurred into action by the US FDA’s ruling that makers of fluoroquinolone drugs had to issue a “black box” warning – the FDA’s strongest safety warning – on these drugs. Black box warnings don’t come along all that frequently and they usually emerge after much negotiation between the manufacturers and the regulator. A “black box” often precedes the removal of a drug from the market and it is a serious signal that the regulators are concerned about the drug’s toxicity.

For all you active individuals out enjoying the summer sunshine, the phrase “tendon rupture” is likely to strike fear in your heart. Tendon damage and perhaps a torn Achilles tendon could wreck anyone’s day. And this due to a drug you took for a simple infection? While the potential effects on your tendons from these drugs have been known for some time, what isn’t entirely clear is why any physician would prescribe the drug, being fully aware of the risk it carries when other antibiotics carry no such risk. As far as I can tell, there is no valid evidence that the fluoroquinolones are any better at treating most infections compared to the alternatives, such as older penicillin-type antibiotics.

My knee-jerk reaction is to suspect that the fluoroquinolone antibiotics have been widely prescribed – both mis-prescribed and over-prescribed – and only a little research confirms those suspicions. There is that perennial, but misapplied, axiom “newer equals better,” which has likely driven much of the marketing and subsequent prescribing of these drugs, and as with any newer treatment, the drug roars onto the scene with bells and whistles while the vital safety signals are spoken in whispers years later.

It is obvious to me that these drugs are marketed as being useful for indications for which they would, at best, be someone’s second choice. At least one manufacturer of this type of antibiotic has been slapped on the wrist by the US FDA for “…making false and misleading statements regarding the safety and efficacy” of the treatment in its advertising.

In terms of how well the drugs are being prescribed, one study involving 100 patients in two academic medical centres in the US found that 81 percent of the patients taking fluoroquinolone antibiotics had been given them for an inappropriate indication. In that same study, 43 percent of the patients received these antibiotics as a first-line treatment and 27 percent of recipients had no evidence of an infection. If this study, which was small and perhaps not applicable to the wider population, comes even close to representing the actual use of these drugs in the “real world,” it is a damning indictment of a serious failure in prescribing, made all the more serious because the drugs have the inconvenient capacity to cause “tendon rupture.”

Should we not expect Health Canada, as our drug regulator, to ensure that proper and timely prescribing information, especially safety information, is made available to guide our physicians? Sadly “too little and too late” seems to characterize the safety signals reaching physicians. After a new drug is approved, the marketers jump into action putting the new drug front and centre of our doctors, our hospitals and health clinics, plying them with free samples and glowing literature.

So what can we do to ensure that new drugs are used properly, rather than inadvertently inflicting tendon damage on the population?

Essentially, we need better “real world” data. It is slowly being recognized that Canada lacks the capacity to properly ensure that “real world” data is generated for new drugs, and that vital safety information about how drugs work in the world in which you and I live must be delivered to physicians in a timely manner. We hope that our physicians are acting in the most prudent manner possible when it comes to treating our infections. We also hope they will reserve newer drugs for patients for whom the older, more established classes of drugs clearly don’t work. Although hope is a pretty frail framework upon which to build a drug safety system.

The demand for “Real World Safety and Effectiveness” research around pharmaceuticals is a topic I’ve written about in the past (Common Ground, August, 2007). This need was initially enshrined in the National Pharmaceutical Strategy (NPS), a federal-provincial initiative boldly launched in September 2004, with the goal of providing Canadians with more equitable, sustainable and safer access to new drugs.

Almost four years later, I’m not the only one to notice that the NPS is largely a dud. Some have said that the “new” Conservative government’s mighty tendency to jettison those Liberal initiatives sounded the death knell for the NPS. Others have noted that provincial-federal wrangling over drug issues – the provinces want help to stanch the bleeding of red ink on the provincial drug file while the feds want to please the drug industry – means the NPS is going nowhere fast.

One of the things buried in the NPS’s objectives was a desire to “strengthen evaluation of real-world drug safety and effectiveness” and this recent announcement seems like it’s about to happen, albeit with baby steps.

With prescription drug spending now in excess of $22 billion per year, and a strong public appetite for more rigorous drug safety in Canada, Health Canada announced in mid-July it would provide the seed money needed to set up an independent research network to study the real world safety and effectiveness of prescription drugs in Canada. The business plan behind this network called for about $20 million per year, but Health Canada announced an immediate five percent of that ($1 million dollars) to get things up and running.

The hope is that the provinces will jump in with their own money and make the network a reality, a network that will likely link researchers in Canada, who are already doing “post-market” surveillance work, and allow them to cooperate in tracking real world drug use issues across the country.

No one can argue that Canadians must be protected from the unanticipated, adverse effects of prescription drugs, as the recent drug safety warning related to the fluoroquinolones has highlighted. Some, however, are insulted with the measly five percent Health Canada is kicking in, as it barely represents a down payment on the initiative.

Some have said that regardless of what form Bill C-51 ultimately takes, if it even survives, any promise of a “cradle-to-grave” surveillance of drugs in Canada will have to be bankrolled by “real world” drug data, and this money will ensure that Canadian researchers are organized and funded to use those data.

I say we give credit where credit is due. Health Canada has anted up so let’s wait and see if the provinces will come on board. Only time will tell if they will do their part to make this network fly. Or perhaps this initiative, like so many other important initiatives in the past, is destined to die from the lack of political will.

My strategy? I’m going to say a little prayer for those who are suffering needless Achilles damage this summer and I’ll feel a little guilty as I continue to enjoy running, jumping, hiking and walking. Because of our collective ignorance about a particular class of drugs, many Canadians won’t be enjoying the summer as I will.

It doesn’t have to be this way. Let’s make drug safety a priority this year and put the money behind that decision.

Alan Cassels is a pharmaceutical policy researcher at the University of Victoria and can be reached at; cassels@uivic.ca

If you think you have been injured by a prescription drug, you should call the Canada Vigilance Program at 1-866-234-2345. You can also submit an adverse reaction report on the Med Effect Canada website (www.hc-sc.gc.ca/dhp-mps/medeff/index_e.html).

16 thoughts on “Health Canada takes baby steps toward drug safety

  1. I live in Canada. I have been suffering with tendonitis for nearly 4 months now after taking Ciprofloxacin 250 mg for 10 days twice a day for a UTI. This didn’t show up until 3 months after taking this drug, which makes it very difficult to realize the cause. I have not done anything strenuous nor had any kind of accident. I have reacted to many different medications and keep finding more. My main issue is in my wrist and hands, all the way up my arm to my shoulder and to the right side of my neck. I am right-handed. I have heat and swelling as well as the pain. I have been checking to see if the FDA and Health Canada are aware of the tendonitis and tendon rupture issues. I found that both these groups had announced back in July 2008 that the manufacturers of these drugs were being asked to include a prominent warning on the labels that these drugs can lead to tendon ruptures. The FDA said the warnings were “necessary”, while Health Canada said the makers were being “asked” to include a prominent warning. There is no mention on the information that came with my prescription as to this possible side effect. I am wondering why. Maybe when they are “asked” to do this, it does not mean that they “have to”. The medical doctors and pharmacists do not seem to be aware of this reaction. Why are they not informed by the FDA or Health Canada? I wonder too how many people have these reactions and don’t realize the cause because of the delayed reaction time. I still have UTI but refused to take more Cipro. I was prescribed something else, but am trying other options first.

    • I am in Canada too. I dont know why my dr gave me Norflox for uti, at age 72. The sole of one foot felt numb a couple of times whilst taking it but i didn’t see the connection. One week after finishing prescription went to bed and my legs were burning and tingling and jolts, then from my elbows down for hours. I have had this 24/7 for three months. although my hands feel numb and sting, they are ultra sensitive and even handling the edge of pieces of paper hurt, am still feeling pins and needles in arms and legs, and pain in left shoulder and knee. The tips of fingers hurt a lot when i type even on soft keyboard……there is no cure. I went through cancer treatments thirty years ago, only now to have been given this poisonous medication. Health Canada should be ashamed at still allowing these meds to be dished out and not reserved for serious illnesses where there is no choice. And what is happening to my
      Internal organs? Every day I live in fear of more side effects….. can only hope Karma to the drug companies etc. My thoughts are with the thousands of others this has happened to. Bless you

  2. Sept 2007 I was issued Cipro as a precautionary measure when traveling in Ecuador. Dec. 2007 while in Ecuador, I took Cipro for 1.5 days and stopped due to itching. I returned home a few days later and was issue Levofloxacin which I took for another 3 days. 6 weeks later my ankles began to give out followed by extreme pain in foot and ankles. 5 years later, I still have bad pain, spasms and difficulty walking. At no time was I informed of any such side effects. Sue them out of existence!

  3. I was poisoned two years ago just by taking 1 Avelox pill. My body began to have adverse reactions within a half hour. I started reacting as if I was having a stroke. My body has since become a mess. I am in constant pain muscle, nerve and bone pain. I have to deal with chronic complex migraines now. Vertigo. These pills are poision and doctors should and need to be more informed on what it is that they are giving to their patients. It is a shame that the pharm companies are not taking these drugs off the market but also by not taking them off the market they are increasing their profits not only by the selling of these poisionous antibiotics but than they are making profits off of the other medications that people end up on to control their pain and other injuries. Greed takes over the well being of people. Shame on J&J and Bayer!! Something needs to be done. Please educate yourself before you take any of the medications.

  4. I took 4 pills of Cipro in Feb. of 2007 for sinusitis and still suffer from the side effects today. I have neurological, tendon, joint and speech problems which continue to get worse. Prior to taking cipro I was healthy, active and athletic. Going to the gym, jogging and skiing. Today I walk slow and use a cane from the damage these drugs have caused. I always responded well to the penicillin class of antibiotics and never should have been give such a strong med for such a simple infection. This prescribing is contributing to infections that are resistant to antibiotics not to mention the destruction of my health and the health of thousands of others.

  5. I am a victim of Levaquin. My symptoms on the medication ranged from extreme nightmares, depersonalization, inability to sleep,anxiety attacks, missing time, delerium, fever for 2 hours after I took the pill, then dropped to 96.2 degrees and I was unable to get my body temp up, frozen to the core, inability to empty my bladder, itching, tinnitus, hair falling out, burning skin, broken teeth both times, irregular heartbeats, shaking so bad that I could barely feed myself, semi-hysteria, depression, suicidal thoughts, my skin literally hung from my bones due to collagen degeneration, , lost 15 pounds
    (not in a pretty way) my vision was gone almost overnight. I now have to wear glasses because my vision was so damaged I struggled to see my own hand in front of me. My bones hurt. My tendons snapped. My body ached. My joints swelled. A week after I stopped the meds, I suffered a severe tendon pull from opening a bottle of water. The same arm had tendionnitis of the shoulder and felt like it would fall out of the socket. I could not extend my arm for 3 months. It burned like fire from the pull and my elbow filled with blood. My thyroid seemed to stop working as all of my hypothyroid symptoms returned on top of the Levaquin induced symptoms. The first two month after the discontinuation of the drug was hell, really hell. My blood pressure was so high it terrified my doctor. I was a stroke just waiting to happen.
    It took me four months to regain my memory. I still remember very little of the floxing week. I do remember freaking out over the periods of missing time. I did tell everyone around me that I was having dark thoughts and voices telling me to kill myself. These drugs are toxic and should be a drug of last resort, not an every day RX for everyone. This could happen to you.

  6. Was prescribed cipro 500mg twice a day for 3 days on feb 1, 2011 for a uti that i actually found later after the culture came back that it wasnt actually even an infection. ive been trying to recover for the past 11 months from what this drug did to me. Cipro caused me neuropathy, tendon pain, muscle pain and weakness, joint pain and popping, fatigue, dry eyes, dry mouth, brain fog, insomnia, hair loss, digestive issues, and ringing of the ears. Im not sure if there is one thing in my body that hasnt been affected by this horrific drug. I was given no warning by my dr. or my pharmacist that this antibiotic could cause any of this!  People need to be aware of the dangers associated w/ this class of drugs, please stay away from fluroquinolone antibiotics!

  7. Another March 2010 Cipro victim here.  Severe generalized tendonitis, completely crippled and disabled as a result of taking this antibiotic for a simple UTI, with no end in sight.  Lost my job, my career, my finances, my partner, my social life, and any hope of a reasonable future.  Was a fit athlete with no known health problems before taking 10 tiny pills.  After almost 2 years, I am slowly "recovering", but am losing hope of ever being my old self again.  A "little Achilles damage"? Sure wish it was just that.  Maybe then only my summer would have been wrecked, instead of the rest of my life.

  8. Avelox destroyed my body… 2 years later I have severe collagen loss. Please do more research to help people with our toxicity.

  9. I too am a victim of Levaquin. I was given 3 rounds of the medicine in January 2011. I have been suffering with numerous adverse effects from this drug. I have been very slowly recovering with the help of a doctor who is aware the toxic effects of this medication. So far I have spent $15,000. of my own money to try to recover my health. I have left my job, because I feel so weak from all of the effects of this medicine. I have discovered that there are many, many people who are suffering like me. Why could a medicine approved by the FDA be on the market that hurts people so much? It's an outrage, and somethin has to be done. 

  10. I took Levaquin 750 mg * 4 tablets on 11-17 through 11-20-11.  Since then I have had horrible side effects including nightmares and panic attacks, tendon/muscle/joint pain and popping, burning sensations in my skin, hives, loss of breath, and many other awful things.  Ended up at the doctor 3 separate times and the ER once.  All because of this poison!  Please take this off the market.

  11. I am also a victim of the antibiotic Cipro.. I am 22 years old and was given Cipro for a measly UTI. Ever since taking this drug, my life has turned upside down. I have severe tendonitis over my entire body, as well as muscle and nerve pain. The adverse reactions do not simply stop there, they will affect every system in your body and will take years to recover. I have been disabled, unable to walk for more than 3 minutes, for 5 months now and I'm not getting any better. PLEASE be careful with these drugs, and they should only be used as a last resort.

  12. In the fall of 2007 I was given Levaquin, one of several antibiotics in a class called fluoroquinolones which also includes Cipro, Avelox and some others. No one discussed the many possible side effects with me despite the fact that this drug has what is called a black box warning, the most serious warning about problems there is before a drug is removed from the marketplace entirely. In fact, more than half of all the related drugs have already been banned.

    I immediately began to feel sick but I was already dealing with a variety of other post surgical issues and was whacked on pain pills so no one took me seriously. In the course of the next few months I endured a horrible series of medical problems and yet no one caring for me was able to figure out what was going on despite the fact that nearly all these things are listed in the literature about Levaquin.

    I was dizzy, nauseous, tired and confused. I lost control of my bladder and had horrific gas and diarrhea. My whole body hurt. I had blood clots. I had ruptured tendons and unexplained cartilage damage. My blood pressure went through the ceiling. My prostate bloated up. I had insomnia. I had pulmonary edema. My stomach hurt and I had terrible heartburn. I had a hematoma and huge varicose veins erupted on my leg. I had rashes all over, and mysterious bruises, and my wounds wouldn't heal. My skin felt like bugs were crawling around underneath it. I had tingling sensations in my back that went all over my body. I had unprompted sharp pains all over that appeared and disappeared. My joints hurt and they began popping loudly. I had ringing in my ears. I had wild crazy panic attacks. I couldn't understand what I was reading, or make sense of signs, or follow a TV show, or even tell time. My vision deteriorated rapidly. My blood oxygen levels were low. And for some reason I was really depressed.

    As of January 2012, it's been almost four and a half years since I was floxed (that's the informal term for victims of fluoroquinolone toxicity) and I am still a mess. Fortunately, things aren't nearly as bad as they were. At this point I am able to work part time but that will probably not last a whole lot longer; my discs are crumbling and my knees are going. Unfortunately, the damage from fluoroquinolones is permanent and ongoing; as some things heal others continue to deteriorate.

    Fluoroquinolones were designed to be a last resort antibiotic and yet they are being prescribed for sinus and urinary infections. The manufacturer admits that all these side effects happen but they claim that only 0.7% of the population will experience them, and yet if you Google these drugs page after page after page will come up with support groups and facebook pages and stories of misery just like mine. The problem is that the onset of these symptoms is often delayed, sometimes by months or even years so a huge percentage of the victims have no idea what caused the problems. They are then misdiagnosed. The other problem is that most people who get symptoms get most or all of them. The problems are systemic; fluoroquinolones alter the DNA. The problems are also permanent.

    There is very little research being done in regards to this problem because the various producers of these drugs are making huge profits selling them. They are in complete denial that these problems even exist and the FDA is ridiculously underfunded and overworked. This page is my attempt to try and remedy this situation. Please check my wall for information about other pages in facebook, as well as websites and so on regarding this problem and possible solutions.

    DO NOT TAKE LEVAQUIN, CIPRO, OR AVELOX!

    Thank You,

    Mark Girard

  13. I'm also a fluoroquinolone victim. I used to be very fit and athletic… going to the gym 2x/week, biking daily, hiking on weekends, kayaking in the summer. I took Cipro for 10 days in March, 2010 and developed severe, body-wide tendonitis that is still with me today. Furthermore, I also developed neuropathy. 2 years later I'm still basically disabled: I now need an electric scooter to move around. Do not take these dangerous drugs!
     

  14. I took cipro in december of 2010 and it took me over 8 months to recover from a list of over 20 adverse reactions, encompassing almost every part of my body. I am one of the lucky ones that has recovered relativly quickly.
    Tendon problems are just the tip of the iceburge. The possible adverse reactions caused by Fluoroquinolone antbiotics are endless. There are thousands of people permanantly injured and disabled from these drugs. Very few doctors currently aknowldge the problem, because they are the ones causing it. Dont be one of the victims, educate yourself.
     

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