Neuropathy Just One Of The Statins Side Effects

Today's post from articles.mercola.com (see link below) looks at the risks of taking statins for people with nerve problems amongst other things. Statins are a very fast growing market in a world where heart attacks and strokes plus high cholesterol, are increasing medical issues thanks mainly to modern life-styles. They will work very effectively to reduce cholesterol and thus prevent a whole array of problems but they do have their side effects and many people just aren't aware of the risks they run when taking statins. This especially applies to neuropathy patients and people at risk of nerve damage. Statins can unfortunately bring on nerve damage, or make it considerably worse and as we all know, that's the last thing we want. It's important that if your doctor suggests taking statins that you bring up the subject of potential nerve damage yourself. It needs to be discussed.

The Ugly Side of Statins: Systemic Appraisal of the Contemporary Unknown Unknowns
By Dr. Mercola October 09, 2013

Statin cholesterol-lowering drugs are among the most widely prescribed drugs on the market, bringing in $20 billion a year.1 They are a top profit-maker for the pharmaceutical industry, in part due to relentless and highly successful direct-to-consumer advertising campaigns.

One in four Americans over the age of 45 now takes statins, typically for the primary prevention of heart attacks and strokes. Traditionally, primary prevention usually involves healthy lifestyle choices that support heart health, things like eating right and exercising, yet here we have millions of Americans taking pills instead.

Has anyone unbiased stopped to find out if these drugs are really the best method for heart attack prevention? After all, as researchers noted in the Open Journal of Endocrine and Metabolic Diseases (OJEMD):2

“…naive indiscriminate acceptance of novel mainstream therapies is not always advisable and prudence is required in unearthing harmful, covert side effects.”

This is precisely the task that researchers from Ireland took on by completing an objective review of Pubmed, EM-BASE and Cochrane review databases.3 Their results speak volumes…


“It is beginning to dawn on some clinicians that contemporary treatments are not only failing to impact on our most prevalent diseases, but they may be causing more damage than good. A perfect example of such an issue is the statin saga.” 

The Evidence Is In: Lifestyle Trumps Statins for Primary Heart Attack Prevention

For a drug therapy that appears to offer little by way of primary prevention, the risks were alarming. For every 10,000 people taking a statin, there were:
307 extra patients with cataracts
23 additional patients with acute kidney failure
74 extra patients with liver dysfunction

The landmark review revealed “a categorical lack of clinical evidence to support the use of statin therapy in primary prevention.” They also found that statins actually increase cardiovascular risk in women, the young and people with diabetes. The review also showed that statin therapy increased:
Muscle fatigabilty by 30% with more than 11% incidence of rhabdomyolysis (a life-threatening muscle condition) at high doses
Coronary artery and aortic calcification
Erectile dysfunction, which is 10 times more common in young men taking the lowest dose of statin.
Diabetes
Cancer

The researchers noted:

“There is increased risk of diabetes mellitus, cataract formation, and erectile dysfunction in young statin users, all of which are alarming. Furthermore there is a significant increase in the risk of cancer and neurodegenerative disorders in the elderly plus an enhanced risk of a myriad of infectious diseases. All side effects are dose dependent and persist during treatment.

Primary prevention clinical results provoke the possibility of not only the lack of primary cardiovascular protection by statin therapy, but highlight the very real possibility of augmented cardiovascular risk in women, patients with diabetes mellitus and the young. Statins are associated with triple the risk of coronary artery and aortic calcification.

These findings on statins' major adverse effects had been under-reported and the way in which they [were] withheld from the public, and even concealed, is a scientific farce.

… Cardiovascular primary prevention and regeneration programmes, through life style changes and abstaining from tobacco use have enhanced clinical efficacy and quality of life over any pharmaceutical or other conventional intervention.” 

If You Take Statins, Your Vision Could Be at Risk

The featured review found an increased risk of cataracts with statin use, and this was supported by a new JAMA study,4 which further revealed that the risk of cataracts is increased among statin users, compared with non-users. As a main cause of low vision among the elderly, cataract is a clouding of your eye lens.

It has previously been hypothesized that statin antioxidant effects may slow the aging process of the lens, but the current study revealed that they, instead, raise cataract risk, again calling into question the usefulness of statins for primary prevention of heart attacks. The researchers concluded:

“The risk-benefit ratio of statin use, specifically for primary prevention, should be carefully weighed, and further studies are warranted.” 

Certain Statins May Impair Your Memory and May Even Lead to Amnesia

Still more research revealed that rats taking the statin Pravachol (pravastatin) had impaired learning, with lower abilities to perform simple learning and memory tasks.5 This isn’t exactly news, as in 2012, the US Food and Drug Administration (FDA) announced it would be requiring additional warning labels for statins, one of which warned that statins may increase the risk of memory loss and confusion. The warnings, particularly the one for memory loss, came as the result of anecdotal reports compiled over the previous year…

Interestingly, the animal study found no association between another statin drug, Lipitor, and impaired memory in the rats. But Dr. Duane Graveline, a medical doctor and former astronaut, has written an entire book on this very topic, titled Lipitor: Thief of Memory.

In my interview with him, Dr. Graveline shared his powerful story about how Lipitor caused him severe global transient amnesia, which is what brought him out of retirement to investigate statins. There have been thousands of cases of transient global amnesia and other types of cognitive damage associated with statin use, reported to the FDA’s MedWatch site. It is believed that statin drugs damage your brain by creating a cholesterol deficiency.

Insufficient cholesterol results in your brain not having the raw materials it needs to make biochemicals critical for memory and cognitive function, including coenzyme Q10 and dolichols, the latter of which carry the genetic instructions from your DNA to help create specific proteins in your body that are crucial for cognitive function, emotions and mood.
High Cholesterol Levels May Be Protective

Any discussion of statins would be incomplete without a discussion of cholesterol – the ‘villain’ that these drugs mercilessly lower. Many buy into the conventional belief that lower cholesterol equals a lower risk of heart disease, but this is not always the case. And, in fact, high cholesterol levels are indeed protective in some cases, whereas low cholesterol levels are very clearly linked to chronic disease. Writing in OJEMD, researchers explained:

“Cholesterol is crucial for energy, immunity, fat metabolism, leptin, thyroid hormone activity, liver related synthesis, stress intolerance, adrenal function, sex hormone syntheses and brain function. When prescribing HMGCoA reductase inhibitors [statins] one needs to be cognizant of the fact that the body had increased its’ cholesterol as a compensatory mechanism and investigate accordingly.

We seem to have fallen into the marketing trap and ignored the niggling side effects with regard to the HMGCoA reductase inhibitors. The only statin benefit that has actually been demonstrated is in middle-aged men with coronary heart disease. However, statins were not shown to best form of primary prevention.

… In actual fact, high cholesterol levels have been found to be protective in elderly and heart failure patients and hypo-cholestereamic [low cholesterol] patients had higher incidence of intra-cerebral bleeds, depression and cancer. … We are observing the revealing of the utmost medical tragedy of all time. It is unprecedented that the healthcare industry has inadvertently induced life-threatening nutrient deficiency in millions of otherwise healthy people. What is even more disparaging is that not only has there been a failure to report on these negative side-effects of statins, there has actually been active discouragement to publish any negative studies on statins.”

This is, in large part, why so many people are completely unaware that statin drugs have been directly linked to over 300 side effects,6 which include:

Cognitive loss Neuropathy Anemia
Acidosis Frequent fevers Cataracts
Sexual dysfunction An increase in cancer risk Pancreatic dysfunction
Immune system suppression Muscle problems, polyneuropathy (nerve damage in the hands and feet), and rhabdomyolysis, a serious degenerative muscle tissue condition Hepatic dysfunction. (Due to the potential increase in liver enzymes, patients must be monitored for normal liver function)

Ask Yourself – and Your informed Physician -- if You Really Need to Be Taking Statins

I've long stated that the odds are very high -- greater than 100 to 1 -- that if you're taking a statin, you may not even need it, as cholesterol is NOT the cause of heart disease. To further reinforce the importance of cholesterol, I want to remind you of the work of Dr. Stephanie Seneff, who works with the Weston A. Price Foundation.

One of her theories is that cholesterol combines with sulfur to form cholesterol sulfate, and that this cholesterol sulfate helps thin your blood by serving as a reservoir for the electron donations you receive when walking barefoot on the Earth (also called grounding). She believes that, via this blood-thinning mechanism, cholesterol sulfate may provide natural protection against heart disease.

In fact, she goes so far as to hypothesize that heart disease is likely the result of cholesterol deficiency — which of course is the complete opposite of the conventional view. So if your physician is urging you to check your total cholesterol, know that this test will tell you virtually nothing about your risk of heart disease, unless it is 330 or higher. HDL percentage is a far more potent indicator for heart disease risk. Here are the two ratios you should pay attention to:
HDL/Total Cholesterol Ratio: Should ideally be above 24 percent. If below 10 percent, you have a significantly elevated risk for heart disease.
Triglyceride/HDL Ratio: Should be below 2.

Additional risk factors for heart disease include: 

Your fasting insulin level: Any meal or snack high in carbohydrates like fructose and refined grains generates a rapid rise in blood glucose and then insulin to compensate for the rise in blood sugar. The insulin released from eating too many carbs promotes fat production and makes it more difficult for your body to shed excess weight, and excess fat, particularly around your belly, is one of the major contributors to heart disease
Your fasting blood sugar level: Studies have shown that people with a fasting blood sugar level of 100-125 mg/dl had a nearly 300 percent increase higher risk of having coronary heart disease than people with a level below 79 mg/dl
Your iron level: Iron can be a very potent oxidative stress, so if you have excess iron levels you can damage your blood vessels and increase your risk of heart disease. Ideally, you should monitor your ferritin levels and make sure they are not much above 80 ng/ml. The simplest way to lower them if they are elevated is to donate your blood. If that is not possible you can have a therapeutic phlebotomy and that will effectively eliminate the excess iron from your body 

Try This Instead for Primary Heart Attack Prevention

Make no mistake about it, statin drugs are some of the most side effect-ridden medications on the market, and they frequently do more harm than good. Of utmost importance, statins deplete your body of CoQ10, which accounts for many of its devastating results. Therefore, if you take a statin, you MUST take supplemental CoQ10, or better, the reduced form called ubiquinol. If you are interested in optimizing your cholesterol levels (which doesn't necessarily mean lowering them) and lowering your risk of heart disease and heart attacks, there are natural strategies available for doing so.
Reduce, with the plan of eliminating, grains and sugars in your diet, replacing them with mostly whole, fresh vegetable carbs and healthy fats. Also try to consume a good portion of your food raw.
Make sure you are getting enough high-quality, animal-based omega-3 fats, such as krill oil.
Other heart-healthy foods include olive oil, coconut and coconut oil, organic raw dairy products and eggs, avocados, raw nuts and seeds, and organic grass-fed meats.
Optimize your vitamin D levels.
Exercise daily, especially with high-intensity interval training (HIIT) exercises.
Avoid smoking or drinking alcohol excessively.
Be sure to get plenty of good, restorative sleep. 


Sources and References

Open Journal of Endocrine and Metabolic Diseases 2013, Vol. 3, No. 3
JAMA Ophthalmology September 19, 2013
Medical News Today September 26, 2013
PLoS ONE 8(9): e75467.

1 Open Journal of Endocrine and Metabolic Diseases 2013, Vol. 3, No. 3
2 See ref 1
3 See ref 1
4 JAMA Ophthalmology September 19, 2013
5 PLoS ONE 8(9): e75467.
6 GreenMedInfo Statin Drugs 
 
http://articles.mercola.com/sites/articles/archive/2013/10/09/statin-cholesterol-lowering-drugs.aspx

Problems With HIV Drug Side Effects Try Acupuncture

Today's post from pacificcollege.edu (see link below) is a general article about the benefits of acupuncture for relieving the side effects of HIV combination drugs. It also specifically references neuropathy which may be of interest to regular readers. Many younger people, especially in the West, where HIV drugs have been significantly refined to reduce side effects considerably over the last few years, may well shrug their shoulders here and say that they have no side effect issues from combination therapy. However, the vast majority of people across the world who are living with HIV haven't achieved that luxury yet. They have to remain on older drug combinations because of resistance issues if they change, or non-availability and they may well have been living with side effects for so long that it's become part of their daily lives. In these cases, this article may be of value. It is important to consult a qualified acupuncturist who knows what he/she is doing and although it is relatively inexpensive compared to many therapies, cost may still be an issue. However, if you can afford it and feel you may benefit, why not try acupuncture/acupressure therapy. If you achieve relief from the symptoms, you may well be able to cut out, or reduce, other (non-HIV) drugs used to control pain.

Acupuncture to Ease the Side Effects of AIDS Drugs
No date or author provided

As drug cocktails continue to be used as a course of treatment for those who have HIV and AIDS, more patients are suffering through debilitating side effects that are caused by these medications. Often patients complain of a wide range of symptoms including, night sweats, nausea, vomiting, depression, insomnia, anxiety, peripheral neuropathy, muscle pains, and sinus congestion. However, acupuncture is now being used to alleviate some symptoms brought on by the powerful drugs. These treatments have been shown to boost the immune system and help fight the side effects brought on by HIV and AIDS.

Redge Norton of the San Francisco AIDS Foundation uses acupuncture, massage and nutritional therapy to combat the side effects of the powerful drugs. "It really helped to get my appetite back to normal," said Norton. "And I feel more like myself again."

Acupuncture is commonly thought of as an alternative form of therapy, although its history as a treatment for physical ailments predates the era of laboratory-produced drugs by several thousand years. Practitioners of this ancient tradition choose from a variety of treatment modalities when developing an individual treatment regimen for a patient. In addition to acupuncture, these modalities include therapeutic massage, stress reduction techniques, and the application of heat and herbs that is known as moxabustion.

A significant number of primary care providers have come to recognize that such therapies should not be thought of as alternatives to Western medicine, but rather as complementary therapies - therapies used in conjunction with, not instead of, conventional drug treatments.

Acupuncture may help relieve bloating, cramping, and appetite loss among HIV-infected people taking drug cocktails to keep the virus in check. In 2005 a study was presented at a meeting of the International AIDS Society. This study included 50 HIV-infected men and women taking HIV medications. About half had been diagnosed with full-blown AIDS.

At the start of the study, all of the participants complained that the drugs caused at least two digestive side effects: nearly 80% had gas, more than 40% had bloating, 50% had cramps, nearly 50% had appetite loss, and 10% had actually lost weight

The participants then received six weeks of acupuncture. For three weeks the acupuncture included four sites commonly associated with improvement of digestive symptoms, such as nausea, vomiting, and bowel upset. For another three weeks they received acupuncture at four sites nearby sites not noted for affecting digestive conditions.

The patients were unaware of which type of acupuncture they were receiving at any given time.

But after just three weeks of acupuncture treatments, only 60% had two or more digestive symptoms. Both sets of acupuncture points improved digestive symptoms. However, acupuncture at the sites targeting digestive symptoms was more effective in controlling loss of appetite, abdominal cramps, and bloating.

In addition, among the 20% of people who said they weren't taking their AIDS medications as directed at the start of the study, half reported improvement after acupuncture treatment. This points out, states researcher Elizabeth Sommers, research director of the AIDS Care Project/Pathways to Wellness in Boston, since they feel better after acupuncture, people are more likely to take their drugs properly, resulting in better disease control.

In this study, none of the participants complained of side effects from the acupuncture.

Pain, a frequent symptom in people with HIV disease, appears to be particularly responsive to the effects of acupuncture. While the exact mechanisms by which acupuncture relieves pain remain obscure, there is clinical evidence to show that it does work. Specifically, acupuncture has become a popular treatment for people with peripheral neuropathy, which is a common complaint of people with HIV. Neuropathy, or nerve damage, manifests as pain, tingling, or numbness in the extremities, usually the feet. After acupuncture treatments patients report less tingling and more flexibility in the joints.

Among the many attractive features of acupuncture therapy are its safety and its relatively affordable cost. Convenience is also a consideration: it is not necessary to plan one's life around acupuncture treatments, which is an additional benefit to individuals who must plan their lives around their HIV and AIDS drug therapy schedules.

Among the many attractive features of acupuncture therapy are its safety and its relatively affordable cost. Convenience is also a consideration: it is not necessary to plan one's life around acupuncture treatments, which is an additional benefit to individuals who must plan their lives around their HIV and AIDS drug therapy schedules.

http://www.pacificcollege.edu/news/blog/2014/04/26/acupuncture-ease-side-effects-aids-drugs

Sexual Side Effects of Peripheral Neuropathy

It's not always the easiest subject to bring up in front of your doctor, especially if you're already over 50. However, if you have neuropathic problems, it doesn't have to be an 'It's just your age", diagnosis and can unfortunately be yet another symptom of nerve damage. For HIV-patients, it can be yet another reason why not everything works the way you want it but it is important to report it because science is moving so quickly in the sexual health area and you may well be able to be helped. One important old wives' tale to dismiss, is the fact that this is just a man's problem - not at all, on the contrary, women with peripheral neuropathy are just as likely to experience sexual problems caused by interrupted nerve signals. This article from livestrong.com (see link below) explains clearly why these problems occur.

Sexual Side Effects of Peripheral Neuropathy
Jul 12, 2010 | By Matthew Busse

Damage to the nerves of the peripheral nervous system is referred to as peripheral neuropathy. The peripheral nervous system is a network of neurons that connect the spinal cord and the brain to the rest of the body. Peripheral neurons are responsible for transmitting physical sensations, like touch and heat, from the skin to the brain. The peripheral neurons also allow the brain to control many processes throughout the body, such as movement, digestion, heart rate and sexual response. Damage to the peripheral neurons resulting from peripheral neuropathy can cause sexual side effects in both men and women.

Damage to Nerves Controlling the Sex Organs

The sexual organs in both men and women are connected to the brain by peripheral neurons. Sexual arousal occurs when the brain registers an excitatory signal and transmits that signal to the sex organs, explains the Boston University School of Medicine. When the sexual organs receive the excitatory signal, neurotransmitters are released that increase blood flow to the sex organs, causing erections in men and labial, vaginal and clitoral engorgement in women, in addition to stimulation of vaginal secretions. If the nerves that connect to the sex organs become damaged, these signals required for sexual arousal cannot reach the sex organs.

Sexual Side Effects in Men

In men affected by peripheral neuropathy, the neurons that connect the penis to the brain may become damaged. As a result, when the brain experiences sexually stimulating input, it cannot transmit that signal to the penis. An erection results from signals reaching the penis that cause its smooth muscles to relax and allow in increased blood flow. Without the signals from the brain, blood flow to the penis cannot be increased, and there is no erection. However, sex drive in men with peripheral neuropathy may remain unchanged. Alternatively, men with peripheral neuropathy may be able to achieve an erection, but they may experience sexual climax without normal ejaculation.

Sexual Side Effects in Women

Similar to men, women require signal transmission through peripheral neurons between the brain and the sex organs to induce the sexual response. When the brain receives a sexually stimulating signal, that signal is transmitted to the vagina. Similar to men, the signal induces the smooth muscles surrounding the vagina to relax and increase blood flow to the vagina, clitoris and labia. In addition to causing engorgement of these organs, the increased blood flow also stimulates vaginal secretions that lubricate the vagina. Women with peripheral neuropathy may not experience physical sexual arousal, leading to vaginal dryness. Women with damage to the peripheral nerves may also have difficulty achieving orgasm.

http://www.livestrong.com/article/171957-sexual-side-effects-of-peripheral-neuropathy/

New Discovery Curbs Nerve Pain Without Drug Side Effects

Today's post from sciencedaily.com (see link below) is one of those complex technical ones that often leave us scratching our heads to wonder how it could possible affect our own personal situations. However, if you take a little time to read it, you should get the gist of what it's saying and what the implications are. It starts off with a neuropathy-patient-friendly call for treatments that work well on people and not just laboratory mice. We are so used to the newest developments being announced at the rodent-testing stage, that we lose faith that they will ever be translated to human treatment. This article tries to show that the gulf between lab-rats and humans in this case, is not so large after all. Worth a read.

Potent approach shows promise for chronic pain
Inhibitor discovered through human, mouse genetic studies curbs pain without narcotic side effects 
Date:June 17, 2015 Source:Boston Children's Hospital

Non-narcotic treatments for chronic pain that work well in people, not just mice, are sorely needed. Drawing from human pain genetics, an international team led by Boston Children's Hospital demonstrates a way to break the cycle of pain hypersensitivity without the development of addiction, tolerance or side effects.

Their findings, reported June 17 in the journal Neuron, could lead to treatments for chronic pain conditions caused by nerve damage, such as diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN), as well as chronic inflammation, like rheumatoid arthritis. Current treatments provide meaningful pain relief in only about 15 percent of patients.

"Most pain medications that have been tested in the past decade have failed in phase II human trials despite performing well in animal models," notes Clifford Woolf, MD, PhD, director of Boston Children's F.M. Kirby Neurobiology Center and a co-senior investigator on the study with Michael Costigan, PhD. "Here, we used human genetic findings to guide our search from the beginning."

In 2006, Costigan, Woolf and colleagues showed in Nature Medicine that people with variants of the gene for GTP cyclohydrolase (GCH1)--about 2 percent of the population--are at markedly lower risk for chronic pain. GCH1 is needed to synthesize the protein tetrahydrobiopterin (BH4), and people with GCH1 variants produce less BH4 after nerve injury. This suggested that BH4 regulates pain sensitivity.

"We wanted to use pharmacologic means to get the same effect as the gene variant," says Alban Latremoliere, PhD, also of Boston Children's Kirby Center, who led the current study along with Woolf and Costigan.

In a "reverse engineering" approach, the researchers modeled the human biology in mice. They first showed that mice with severed sensory nerves produce excessive BH4, churned out both by the injured nerve cells themselves and by macrophages--immune cells that infiltrate damaged nerves and inflamed tissue. Mice engineered to make excess BH4 had heightened pain sensitivity even when they were uninjured, suggesting that BH4 is sufficient to produce pain. On the flip side, mice that were genetically unable to produce BH4 in their sensory nerves had decreased pain hypersensitivity after peripheral nerve injury.

"We then asked, if we could reduce production of BH4 using a drug, could we bring about reduction of pain?" says Latremoliere.

The answer was yes. The researchers blocked BH4 production using a specifically designed drug that targets sepiapterin reductase (SPR), a key enzyme that makes BH4. The drug reduced the pain hypersensitivity induced by the nerve injury (or accompanying inflammation) but did not affect nociceptive pain--the protective pain sensation that helps us avoid injury.

Fine-tuning pain relief

Because BH4 is active all over the body, with important roles in the brain and blood vessels, the goal of any treatment would be to dial down excessive BH4 production, but not eliminate it entirely. Latremoliere and colleagues showed that blocking SPR still allowed minimal BH4 production through a separate pathway and reduced pain without causing neural or cardiovascular side effects.

"Our findings suggest that SPR inhibition is a viable approach to reducing clinical pain hypersensitivity," says Woolf. "They also show that human genetics can lead us to novel disease pathways that we can probe mechanistically in animal models, leading us to the most suitable targets for human drug development."

Story Source:

The above post is reprinted from materials provided by Boston Children's Hospital. Note: Materials may be edited for content and length.

Journal Reference:
Clifford J. Woolf et al. Reduction of Neuropathic and Inflammatory Pain through Inhibition of the Tetrahydrobiopterin Pathway. Neuron, June 2015 DOI: 10.1016/j.neuron.2015.05.033

http://www.sciencedaily.com/releases/2015/06/150617135409.htm

Check Your Antibiotics For Nerve Damage Side Effects!

Today's post from healthycanadians.gc.ca (see link below) returns to the subject of the commonly prescribed antibiotics called fluoroquinolones (among others:ciprofloxacin (CIPRO, CILOXAN) enoxacin (PENETREX)  levofloxacin (LEVAQUIN) moxifloxacin (AVELOX) norfloxacin (NOROXIN, CHIBROXIN) ofloxacin(FLOXIN, OCUFLOX) and their dangers, especially to patients prone to, or living with nerve damage. This article backs up FDA warnings in the States and others across the world stating that these drugs are dangerous. It couldn't be clearer in that and yet doctors across the world, (pushed by pharmaceutical reps) continue to issue these drugs like M&Ms, with scant regard for their potential for serious side effects (including nerve damage). If your doctor suggests one of these antibiotics as a cure for an infection, please discuss it with him or her first and try to arrange one of the various safer alternatives. There are other articles here on the blog on the same subject. Using the Search box, type in 'fluoroquinolones' and check out the evidence for yourself.

FLUOROQUINOLONES - Risk of Disabling and Persistent Serious Adverse Reactions
January 23, 2017 Posting date:

Dear Healthcare Professional Letter Subcategory: Drugs Source of recall:
Health Canada Issue: Important Safety Information 
 Audience:Healthcare Professionals, General Public Identification number: RA-61900
Issue
Who is affected
Report health or safety concerns
Related AWRs
 
Audience

Healthcare professionals

Key messages
 
Rare cases of disabling and persistent serious adverse reactions including tendinopathy, peripheral neuropathy, and central nervous system disorders have been reported to Health Canada for fluoroquinolones when used systemically (i.e. taken by mouth or by injection). 

Healthcare professionals are reminded to:
Consider the potential for disabling and persistent serious adverse events when choosing to prescribe a fluoroquinolone.
Avoid fluoroquinolones in patients who have previously experienced serious adverse reactions associated with them.
Stop fluoroquinolone treatment if a patient reports any serious adverse reaction. Patients should be switched to an alternative treatment with a non-fluoroquinolone antibacterial drug, if needed, to complete the treatment course.
Health Canada is currently working with manufacturers to strengthen the prescribing information for these drugs.

Issue

Canadian and international cases of disabling and persistent serious adverse reactions including tendinopathy, peripheral neuropathy, and central nervous system disorders have been reported in patients treated with oral and injectable fluoroquinolones.

Products affected

FLUOROQUINOLONES (ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin), oral and injectable dosage forms.

Background information

Fluoroquinolones are a class of antibacterial drugs used in the treatment of various gram-negative and gram-positive bacterial infections, including respiratory and urinary tract infections.

Health Canada conducted an assessment to examine the safety of systemic fluoroquinolones. This was prompted by the findings of the United States Food and Drug Administration benefit/risk assessment on systemic fluoroquinolones and the occurrence of disabling and persistent adverse reactions.

Health Canada’s safety review focused on already known and labelled adverse reactions associated with the use of fluoroquinolones that resulted in persistent disability. Health Canada has received reports of a small number of these cases over time.

The reported adverse reactions in Canada associated with persistent disability mostly involved the musculoskeletal system (e.g., tendonitis and Achilles tendon rupture), peripheral neuropathy and central nervous system disorders (e.g., depression, anxiety, dizziness and confusion).

Health Canada’s assessment concluded that fluoroquinolones are associated with rare cases of disabling and persistent serious adverse reactions such as tendinopathy, peripheral neuropathy, and central nervous system disorders.

Health Canada consulted the Scientific Advisory Panel on Anti-Infective Therapies (SAP-AIT) on the use of fluoroquinolones for treating certain infections, considering their potential association with disabling and persistent events. The SAP-AIT recommended labelling updates to all systemic fluoroquinolones to include information on the severity and persistence of these adverse reactions.

Who is affected
Information for consumers

Fluoroquinolones are a class of prescription antibacterial drugs that are used to treat several types of bacterial infections.

Fluoroquinolones are generally well tolerated but they have been associated with rare serious side effects that were disabling and persistent, including tendon damage, nerve damage in the hands and feet, and central nervous system disorders. These side effects can occur hours to weeks after exposure to fluoroquinolone treatment.

Patients should inform their healthcare professional if they think they have previously experienced a side effect related to fluoroquinolone use. Patients should immediately consult a healthcare professional if they experience serious side effects, such as joint and muscle pain, swelling or rupture of a tendon, tingling, numbness, weakness, or other alterations of sensation, tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, suicidal thoughts.
Information for healthcare professionals

It is recommended that the potential for disabling and persistent serious adverse events be considered when choosing to prescribe a fluoroquinolone.

Fluoroquinolones should not be prescribed to patients who have experienced serious adverse reactions during or after prior treatments.

Healthcare professionals are advised to stop systemic fluoroquinolone treatment if a patient reports a serious adverse reaction. The patient’s treatment should be switched to an alternative treatment with a non-fluoroquinolone antibacterial drug if needed to complete the treatment course.

Healthcare professionals should be aware that some adverse reactions associated with the use of fluoroquinolones can occur within hours to weeks after exposure to the treatment.
Action taken by Health Canada

Health Canada is working with the manufacturers to update the fluoroquinolone Canadian Product Monographs. Health Canada continues to monitor the situation and will take further action as deemed necessary.

Health Canada is communicating this important safety information update to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication update will be further distributed through the MedEffect™ e-Notice email notification system.
Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving fluoroquinolones should be reported to Health Canada.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
Calling toll-free at 1-866-234-2345; or
Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Product Directorate

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738
Related AWRs

Information Update - Fluoroquinolone antibiotics may, in rare cases, cause persistent disabling side effects


2017-01-23 | Health products

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2017/61900a-eng.php

HIV And Its Medications Possible Side Effects

Today's useful post from aidsinfonet.org (see link below) is aimed at people living with the side effects of HIV and its medications, including neuropathy (which is a significant and underestimated consequence of HIV for roughly a third of all positive people).
The post lists the main side effects people living with HIV may have to deal with and provides links to more information on each one. Those who imagine that being HIV+ these days is just a matter of taking one pill a day and living a normal lifespan, may want to think again in light of these potential problems. Those with both HIV and neuropathy already understand that very well.

Side Effects and Their Treatment

July 27, 2013

To see a list of fact sheets in each category, click on the category name.

NOTE: You can see a full list of fact sheet topics on Fact Sheet 1000.

Treatments for Side Effects

550. Side Effects

A discussion of the most common side effects of antiretroviral treatment, with links to other fact sheets for more information. Includes fatigue, anemia, digestive problems, lipodystrophy, peripheral neuropathy, mitochondrial toxicity, and osteoporosis.

[Reviewed August 12, 2012]

551. Fatigue

A description of fatigue among people with HIV, its causes and treatment.

[Reviewed April 10, 2013]

552. Anemia

A description of anemia among people with HIV, its causes and treatment.

[Reviewed June 18, 2013]

553. Body Shape Changes (Lipodystrophy)

A description of lipodystrophy (changes in metabolism and body shape) in people with HIV, its risks, suspected causes and treatment.

[Reviewed November 14, 2012]

554. Diarrhea

A description of diarrhea in people with HIV, its causes and treatment.

[Revised December 31, 2012]

555. Peripheral Neuropathy

A description of peripheral neuropathy in people with HIV, its causes and treatment.

[Revised December 19, 2012]

556. Mitochondrial Toxicity

A description of mitochondrial toxicity in people with HIV, its causes and treatment.

[Reviewed August 13, 2012]

557. Osteoporosis

A discussion of loss of bone mineral density associated with HIV and its treatment, including osteoporosis

[Revised June 2, 2013]

558. Depression and HIV

Depression is common in HIV

[Revised July 29, 2012]

559. Osteonecrosis

Definition and description of osteonecrosis (bone death) in HIV

[Reviewed August 13, 2012]

http://www.aidsinfonet.org/categories/view/17

Pregnancy Side Effects

Mirena Iud And Bleeding

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Mirena Iud And Bleeding

Sucralose Side Effects

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Antibiotic Side Effects Include Neuropathy Vid

Today's post from click2houston.com (see link below) is a video with transcript of a news report on fluoroquinolone antibiotics such as Cipro and Levaquin (amongst others). The warning is clear and has been highlighted several times on this blog, yet these antibiotics are still routinely issued in their millions every day across the world. Be warned; if you're susceptible to, or already have neuropathic symptoms, it may be best to stay well clear of these antibiotics. At the very least, a serious discussion with your doctor may be necessary - there are always alternatives.

Thousands of adverse reactions reported from common antibiotics
Patients claim they were not properly warned of side effects from Levaquin, Ciprofloxacin
Author: Haley Hernandez, Reporter Published On: Apr 13 2015





HOUSTON - Less than a year ago, David Crain, a healthy and vibrant 33-year-old musician and personal trainer, was in the prime of his life. “I was running 6 miles in the August heat with my shirt off, screaming, yelling, listening to music effortlessly,” he said. Now, he can barely play his guitar.

Just about all I can do. It's hurting. If I do it now, I'll pay for it later,” Crain said.

Last June Crain went to the emergency room for what doctors believed was colitis. He was prescribed the antibiotic Ciprofloxacin, a generic form of Bayer’s Cipro, and began taking the recommended dosage.

“I think around about day seven or day eight, I just noticed like every time I would stand up I’d just be super-fatigued,” Crain said. “My ears rang all the time, I had trouble walking in the second month. My shoulders hurt, my tendons hurt.”

Tammy Renzi was prescribed the antibiotic Levaquin for a sinus infection. Six days into her 10-day dosage, she said she knew something wasn't right.

“I had a heaviness in my thighs. I had pressure in my lower spine. My vertebrae felt like they were rubbing on each other and I could hear the snapping in them,” Renzi said.

Both Crain and Renzi are not alone. From November 1997 to May 2011, more than 85,000 adverse reactions to Levaquin were reported to the Food and Drug Administration, including 1,174 deaths.

More than 67,000 adverse reactions to Cipro were also reported, including 1,257 deaths.

Dr. Charles Bennett, state chair of Medication Safety at the University of South Carolina, has been tracking the issue. He said Crain and Renzi's reactions may be caused by a mysterious genetic predisposition.

“Research should be done to identify those genetic factors,” Bennett said. “You certainly wouldn't want to take a drug if you knew you had a genetic predisposition to its side effects.”

Until that research is done, Bennett has petitioned the FDA, requesting stronger warnings.

“The current insert has a black box warning for tendon rupture and neurologic damage. It needs to be beyond the package insert,” he said.

Channel 2 Investigates reached out to both drug manufacturers.

According to Bayer Corporation, the FDA issued a drug safety communication requiring that "the drug labels and medication guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy."

Johnson & Johnson, Levaquin’s parent company, wrote, “Since 2004, the Levaquin label has informed physicians and patients about possible side effects related to peripheral neuropathy.”

Crain and Renzi said they want everyone to know the risks so that they don't end up with the same fate.

“I wouldn't take it again if my life depended on it,” Renzi said.

“My biggest fear is that I’m, you know, my son is never going to know who I was,” Crain said.

Renzi and Crain are not currently considering legal action, but in 2012 Johnson & Johnson settled lawsuits with 845 plaintiffs who claimed they were not properly warned about the risks.

http://www.click2houston.com/news/more-than-2000-adverse-reactions-reported-from-common-prescription-medications/32350128