Several important drug studies were just published in the journal JAMA Internal Medicine this week. They revealed some serious new complications linked to popular drugs such as:

  • Prednisone
  • Tiotropium (Spiriva)
  • Salmeterol (found in Serevent & Advair)
  • Formoterol (found in Foradil & Symbicort)
  • Zolpidem (found in Ambien)
  • Eszopiclone (found in Lunesta)
  • Zaleplon (found in Sonata)

 CORTICOSTEROIDS & BLOOD CLOTS

When cortisone became available in 1949, it was considered a miraculous medicine. It eased the pain and inflammation of rheumatoid arthritis in ways no other drug had ever done. Similar corticosteroids followed, including dexamethasone, hydrocortisone, prednisone, prednisolone and methylprednisolone.

It took many years to learn that such drugs produced a wide range of serious complications (see below). Now add a brand new and potentially deadly side effect.

Blood clots in veins are called venous thromboembolism or VTE for short. These are clots that can form deep in the legs or even in the arms. They are far more common than most people realize, affecting anywhere from 300,000 to 1 million people every year. When a clot breaks loose from an extremity and lodges in the lungs (pulmonary embolism or PE for short) it can be fatal. Some experts estimate that as many as 300,000 people die every year from such blood clots.

The study just published in JAMA Internal Medicine reports that starting to take oral corticosteroids like prednisone increases a patient’s risk of VTE by 300 percent. Regular use doubles the risk. Starting inhaled corticosteroids (found in drugs such as Advair, Flovent, Pulmicort and Symbicort) roughly doubled the risk of blood clots.

This is new information and could quickly disappear without a trace because there are so many other side effects linked to such drugs. No one should EVER stop taking a corticosteroid (or any other drug for that matter) suddenly or without medical supervision. Such drugs can be absolutely essential for serious medical conditions. But we think patients should be aware of this new complication and know what to look for to detect either VTE or pulmonary embolism [PE], since symptoms can be somewhat vague.

SYMPTOMS OF VTE OR PE

  • Pain, tenderness or swelling in one leg or arm
  • Diffuse reddish or bluish skin discoloration in one leg or arm
  • A sense of tightness in one leg or arm
  • A feeling of heat in one leg or arm
  • Sudden shortness of breath
  • Chest pain that worsens with deep breathing
  • A cough that cannot be explained by a cold

 [Because pulmonary embolism is a life threatening situation such symptoms require immediate medical attention!]

 OTHER SIDE EFFECTS OF ORAL CORTICOSTEROIDS:

  • Fluid retention, edema

  • Insomnia

  • Irritability, nervousness, mood swings, mania, depression, psychosis

  • Disorientation, confusion

  • Hypertension

  • Loss of potassium

  • Headache

  • Dizziness, vertigo

  • Muscle weakness

  • Blood sugar elevation (diabetes)

  • Irregular menstrual cycles

  • Swollen face

  • Hair growth (including on the face)

  • Itching, rash, hives

  • Increased susceptibility to infection

  • Weakened bones (osteopenia, osteoporosis)

  • Tendon rupture

  • Glaucoma 

  • Cataracts

  • Ulcers

BRONCHODILATORS AND THE HEART

Another study published in JAMA Internal Medicine suggests that starting long-acting bronchodilators prescribed for chronic obstructive pulmonary disease (COPD) increases the risk of cardiovascular complications. We’re talking about formoterol (found in Foradil & Symbicort), salmeterol (found in Serevent & Advair ) and titropium (Spiriva).

Health care records from nearly 200,000 people in Ontario, Canada were analyzed. The investigators were concerned about COPD because it affects nearly 25% of older people and is a leading cause of death in senior citizens. That means millions are taking inhaled medications like the drugs listed above. You have probably seen the ads on TV for an older person with an elephant sitting on her chest. It is a graphic demonstration of the challenge such people face with COPD.

The trouble is that these popular medications may pose a heart risk. In this study, researchers found that people starting on such drugs were more likely to land in the emergency department or hospital with a cardiac “event.” That doesn’t mean that they are inappropriate medicines, just that older patients and health professionals should know about this risk and be especially alert for heart symptoms during the initial phase of treatment.

SLEEPING PILLS AND HIP FRACTURES

Another study in last week’s JAMA Internal Medicine revealed that nursing home residents taking sleeping pills such as zolpidem (Ambien), eszopiclone (Lunesta) and zaleplon (Sonata) were more likely to break a hip. This can be a life-threatening event for an older person.

When such sleeping pills became available, doctors thought that they would be less risky than benzodiazepines such as diazepam (Valium), chlordiazepoxide (Librium) or temazepam (Restoril). This study of over 15,000 nursing home residents suggests that assumption was flawed.

Beginning a sleeping pill doubled a resident’s risk of falling and breaking a hip. These drugs impair memory and affect balance, so older people in nursing homes may be especially vulnerable to this complication. This does not mean, however, that everyone else is home free. Older people living at home may also be at greater risk for a fall or a fracture if they are taking one of these sleeping pills.

Getting up at night to pee is especially dangerous. Anyone taking sleeping pills should make sure that the path to the bathroom is unobstructed and can be lit well enough to avoid a fall.

 THE BOTTOM LINE:

All the drugs mentioned above have been on the market for many years. These studies demonstrate that new risks are still coming to light even for familiar medications like prednisone. Although these medications are useful for many, the risks are not trivial. Make sure you are aware of the complications and discuss the pros and cons with your health care provider.

Share your own story below.

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  1. franklin
    south afrika
    Reply

    I am 46 using zolpidem for insomnia now given a course of prednisone for ear infection now finding zolpidem effect cut in half must I stop prednisone immediately or reduce to morning as it was ordered morning and night time?

  2. RT
    Reply

    I have been taking 10mg ambien nightly for 20 years. My memory is pretty bad but I can’t sleep without it. Any suggestions how to stop? I tried cutting the dosage but was up all night. I’m scared about my memory. Is this damage permanent?

  3. Don Selvidge
    Reply

    Epidurals have the same bad effects as do other uses of these drugs except there is not long term exposure. They do not work 2/3s of the time and when they do, they only mast the underlying cause of the problem. Better to use chiroprctic or PT to address the problem causing the pain.

  4. DZ
    Reply

    I took prednisone for more than 20 years for lupus erythematosus. I started with a high dose of 40mg for a short period to get my ANA down.
    Then I went to a 10mg dose every other day for all those years. I never
    had any of those symptoms that I know of. Only insomnia when I was on the higher dose. The drug kept me in a remission all that time which is the goal. I now live in a different state and my Dr. here took me off and said we would use it if needed. I have only used it once or maybe twice in 7 years for a very short time. And I forgot I do have osteopenia but there is no proof it is the prednisone as I also take thyroid medicine.
    I am thankful that it helped me…..but I would probably try not to use it again as I used it for so long. Sometimes as a sick person one has to do to do what an onlooker might not do. Being in a lupus flare is not good either. Always good to hear the latest and try to make a good decision which of course is the hard part.

  5. tutorjb1
    Reply

    TWO SITES FOR MED PROCEDURES AND WHAT THEY SHOULD COST:
    Google and . It’s very late where I am and I’m tired and in Pain, so not entirely sure the URLs are correct. This one’s short for a change. The second may be healthchoicesforus.org.
    Be SURE TO FIND ONE THAT IS NOT A COMMERCIAL FOR ONE INSURER! I couldn’t remember the exact URL I saw in Consumer Reports magazine a couple months ago, but those are close.
    Best Wishes,
    tutorjb1

  6. tutorjb1
    Reply

    Hello. I just read an email from the P’s P and MimiB and wanted to try to comfort MimiB. I’ve tried before by replying to those emails, but they never seem to reach those I try to reach so I’m just making a general comment here.
    I think all these weird-sounding drugs should be left alone unless one is in unrelenting agony and the prescriber is well known and respected. Even then, one should immediately try weaning themselves down to lower doses (if not completely off) drugs suspected of having side effects that are not well understood or have affected others as some who have told of being affected here.
    For that type of information, The P’s P is a great resource (especially when coupled with one’s hopefully wary physician’s advice and the information collected and analyzed for average consumers of medicine by Consumers’ Union in Consumer Reports magazine and even better at http://www.consumerreports.org. Access to the website is discounted for subscribers to Consumer Reports magazine. CR has even recently rated hospitals on criteria very important to patients (after first explaining that criteria, as they do everything they analyze and rate. More hospitals, meds, etc. are rated online than in the magazine, but the magazine is often more detailed in the ratings and explanations it gives.
    I think many people could be comforted by listening to their doctors (and other doctors like those at allexperts.com, reading Consumer Reports and listening to the P’s P; then taking their questions to the web (perhaps with help from experts at allexperts.com then returning to their doctors with the new questions that process raises and REPEATING the entire process until they are satisfied and then keep repeating it because many questions will not be answered in our lifetimes and we need to be as informed as possible to achieve the best results for our health and that of those we love!
    Doctors and the meds and techniques they use are not now and will never be perfect but they have and will improve over time. You must stay vigilant and be aware of the ill effects of certain meds and medical procedures you may be offered!! This is a good place to start educating oneself as is consumer reports! I heard of a great site at healthbook.com. I am almost certain of the url, but not completely. It is like the bluebook for cars, but for hospitals, doctors and meds I will check it and come back with the positive url best wishes, tutorjb1–jb

  7. Sha
    Reply

    How does this equate to the lumbar epidural that I had, and may repeat?
    thanks

  8. MimiB
    Reply

    My elderly mother was prescribed a number of the medications mentioned as troublesome, to treat her COPD. She developed many of the symptoms mentioned, though a couple were attributed to other causes… the red/blue hot leg being one, memory problems, terrible weakness, edema … although she’d been alert, active and mentally bright up until she started taking Spiriva, prednisone and other inhaled meds.
    She kept having episodes that looked like heart attacks, yet weren’t … kept being taken to the hospital for treatments… it was a terrible way for her to end her life in her 93 year. She’d been so healthy until she started taking those meds. Yet we were told there were no other treatments.
    I honestly think that when she died suddenly one night it was because of a pulmonary embolism. Her primary care doctor thinks so. Now I read that that can be caused by these CORTICOSTEROIDS. Her mother, her aunt… all lived to ripe old ages [98, 102] almost disease free until their ends. I think Mom might have lived longer and healthier without the treatments.

  9. Eleanor K.
    Reply

    I lived in Rochester Minnesota when two researchers, friends of my family, discovered cortisone in the 1940’s. They gave large doses to patients and there were pictures of patients “dancing in the halls” of the hospitals. Unfortunately, they did not know the side effects and one of my friend’s mother died. I am sure there were others, but that is the only one I knew personally.
    Ellie K.

  10. LF
    Reply

    You need to distinguish between what are pharmacologic vs physiologic doses of corticosteroids, and how the potency varies between them as compared to hydrocortisone. Most doctors have no idea what a physiologic dose is, or how to use it, and prescribe amounts of these drugs that are way above and beyond what could adequately do the job.
    I would suggest reading the book “Safe Uses of Cortisone” by Dr. William McKesson Jeffries, who pioneered the use of cortisone in humans. I had the privilege of meeting him many long years ago. His book should be required reading for all medical students, as well as any physician that prescribes the drug.

  11. DGuidry
    Reply

    Many years ago (actually about 20yrs ago) I was prescribed prednisone for a sinus infection. I took the six initial pills, and a couple of hours later I was literally climbing the walls, screaming at everyone, and honestly felt I was going crazy. My husband at the time reminded me that steroids sometimes causes roid rage. Yes, I know the steroids I was given was different, but that revelation made me feel better.
    I stopped the drug immediately and finally after a couple of days I was feeling better. I do have Borderline Personality, have no clue if that may have exacerbated my symptoms, but after that episode I refuse to take any steroid applications.

  12. Helen M
    Reply

    Cindy, because I am 75, I have seen much of the evolution of medicine away from being an art, practiced with care and carefulness. And towards seeing a doctor, with a computer, who never touches you, sometimes does not even look at you, and is deeply in love with pharmaceuticals.
    We need to turn medicine back to prevention, away from traumatic care and drugs, with nothing the rest of the time. Maintenance of so many conditions is now left up to the patient, where are our resources? Worse is that so many of the conditions are “life style” induced, with no help from a doctor before you fall over the edge.
    Or maybe we should have been scared into reforming our ways when we were in high school with classes in personal health? Many classes!
    Or perhaps we should think about a national health system, where doctors are attracted to medicine because they want to help, not because they want to form corporations and become millionaires. But first we, including the medical establishment, must admit that the present paradigm is a failure and focus ourselves on healthy change.

  13. JAS
    Reply

    At age 21 I took prednisone due to swollen throat/glands. I could practically feel my lymph nodes shrinking soon after I swallowed the pills & I got better very quickly with no side effects. Age 48, doctor gave me methylprednisolone & my heart started to speed up enough to go to the ER. ER doctors kept me overnight for observation.
    I will never again take methylprednisolone or prednisolone. So at age 21 I took prednisone & it was a miracle drug that kept me out of the hospital. I took methylprednisone or prednisolone at age 48 for extreme pain/inflammation in my shoulder and I ended up in the hospital. Wonder what I was “sensitive” to? I ALWAYS have problems with generic drugs. Wonder if this had something to do with it?

  14. tutorjb1
    Reply

    39 years ago I was almost killed by a major stroke-like injury that left me with a serious limp. Therefore, I must be extremely careful where and how I walk. Because of that I compensate well for the effects of the zolpidem I take often. I believe (and have proven to myself) that many procedures doctors want to perform on one can best be handled Not by altering one’s body, but by altering one’s environment.
    Since my left foot has cramps and spasms with every step (sometimes worse than others), I keep a plastic bucket near my bed for those times I realize I am not going to make it to the bathroom to urinate (especially at night) with my usual caution. I suggest that as a solution to the zolpidem problem mentioned above for those who believe they may experience it. I also go directly to bed after taking the zolpidem after shutting down my PC and anything else I know I’ll need to get up to do. The bucket is three steps away near my computer table and a wall (both of which I can use to support myself while using the bucket that is easily emptied in the morning.
    Zolpidem enters one’s system and helps people sleep quickly. Many are aware of that. It seems that fewer are aware that zolpidem exits one’s system just as quickly, so there is no “hangover” in the morning after waking, which makes it possibly the best “sleeping pill” currently available. Restoril used to keep me up all night wondering if it was ever going to put me to sleep and making me angry when it didn’t and Restoril and others DO leave one with a dangerous “hangover” the following day, when they finally show their effects.
    Thank you.
    JB

  15. DCM
    Reply

    Thanks Joe and Terry – hey, is Nasonex an issue at all? It is a corticosteroid that I use maybe one month per year for seasonal hay fever – when combined with over the counter generic Claritin (from Costco – Kirkland brand) the combination does wonders for runny nose and itchy eyes. My primary care doctor recommended this combination. I have looked up “side effects” for Nasonex and haven’t found anything except for extreme unusual situations – people with compromised immune systems, etc. Just wanted to confirm that Nasonex is not on “the list.” Thanks – Derek
    Peoples Pharmacy response: Nasonex is not on the list. Perhaps the occasional nature of use makes it less problematic.

  16. tytania891
    Reply

    I am curious to know whether these side affects also apply to things like steroid-based nasal sprays for allergies. My son recently resumed taking one of these after a long break due to recurring sinus infections. For the last two weeks, he has been more moody, brooding and agitated and now I can’t help wondering if this mood is related to the steroid-based nasal spray. He is using a generic form of nasonex. I think the drug is called fluticasone?

  17. MM
    Reply

    I have had to take Prednisone for many years due to R/A & other conditions. I think this is just another case of causing people to panic! Everything you put in your mouth has risks!! Even the food we eat is no longer safe. What you have to think about is if you are unable to live a normal life without these medications then what is the point??

  18. jn
    Reply

    It is important to note that prescription medications have post market monitoring and the problems (ie side effects) are reported to the FDA. Whereas vitamin, homeopathic, herbals do not require any proof they work and have NO post marketing monitoring unless they severely injure someone.
    The vitamin, homeopathic, herbals do not even have ANY GUARANTEE that the labeled ingredients are in them. Whereas prescription and nonprescription medications approved by the FDA can be recalled by the FDA as mislabeled if they do not contain the labeled amounts of ingredients the Dietary Supplement Health and Education Act of 1994 does NOT require prior approval of the FDA before marketing of any vitamins, homeopathic, or herbals.

  19. Anne
    Reply

    Does this apply to steroid nasal sprays like Nasonex?
    Peoples Pharmacy response: steroid nasal sprays were not specifically named. The dose may be lower, and that may offer some protection.

  20. frenagd
    Reply

    I work exclusively with elders as a caregiver. Well-meaning family members have absolutely no idea how much their own parents are endangered by the daily meds of elder-conditions. And, it seems, neither do their doctors. People need to understand that their own knowledge is often the only protection for their elderly parents. So I hope all adult children with elder parents read these invaluable articles you post. I always post them on behalf of others.

  21. msc
    Reply

    Do injected cortisone shots, e.g., shots for osteoarthritis in knees, have the same risks?

  22. Cindy
    Reply

    This illustration seems to fit too much of what is happening in medicine. You stand on the bank of a fast-moving stream and someone comes up and pushes you in. Then they throw you a rope and say, “Here, let me save your life.” And you are suppose to be grateful? Humm, I don’t think so.
    One of my dear friends just had this very thing – VTE develop from long-term use of steroids to help his lungs! The irony is that the VTE settled in his lungs this time {again} and, if he had not already been in a convalescent hospital waiting to be discharged for home, he might very well have died before emergency personnel could have responded.
    Another friend told me recently that his battle for his life because of VTE started from a very long airplane ride that triggered the blood clots. He was an otherwise healthy man. That is an important reminder to move about in every way possible if you are forced to be in a cramped position for a length of time.

  23. Ali
    Reply

    I have Copd I take Advair and Spiriva as well as several oral forms of breathing help. I am only 56 is there other hope? Other meds?
    Ali

  24. Greg McP.
    Reply

    Great…! Another terrible side effect to add to the already long list of terrible side effects resulting from corticosteroid use.
    These are indeed ‘miracle’ drugs and nothing else works as well in many conditions such as autoimmune illness, COPD etc… especially acutely for flares.
    Sometimes the best drug to treat a condition has the worse side effects and steroids are probably the best example.

  25. Judy Z
    Reply

    I take budesonide (generic Entacort) for lymphocytic colitis. It is a corticosteroid, but is it on the “list”, or are these results for all corticosteroids? Thank you for the warning!
    Peoples Pharmacy response: Budesonide was not specifically listed, But corticosteroids for intestinal treatment were included.

  26. MM
    Reply

    I have had several injections of cortisone in my right shoulder, right wrist, and in my spine.
    How does this effect memeory?

  27. Dr. Judi
    Reply

    Another side effect was described in a wonderful article Ten Feet Tall by Berton Rouche in the New Yorker magazine in 1955.
    http://www.newyorker.com/archive/1955/09/10/1955_09_10_047_TNY_CARDS_000247061
    ACTH and or cortisone could cause manic or depressive symptoms.
    PEOPLE’S PHARMACY RESPONSE:
    Thank you for reminding us Dr. Judi that corticosteroids can have powerful psychological side effects. The New Yorker piece brought this out in graphic fashion.
    We always worry when someone is prescribed a high dose of prednisone (or some other corticosteroid) for a bad case of poison ivy or some other serious condition and is not warned of this potential complication. If you don’t know why you are wired or irritable or hallucinating it can be a very scary experience. Even if you do understand that it is a drug reaction it can still be alarming.
    Our motto is forewarned is forearmed.

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