How to Report Drug Side Effects to the FDA

My post from 2010 on Arimidex side effects continues to receive comments, and I encourage you to keep your doctor and the FDA updated if you have serious side effects with this or any other medication you take.

To report online: https://www.accessdata.fda.gov/scripts/medwatch/

Blogs and support groups are important for learning you are not alone, but if the FDA does not receive reports, there will be no changes to information about the drug.  I'm not trying to get anything taken off the market per se, but if we need specific treatment after cancer, we need a drug that we can live with.

I stopped Arimidex, but only after discussing the risks and alternatives with my oncologist. 

Always contact your doctor immediately if you are having side effects or new symptoms.  You don't have to wait until your next scheduled visit.  Follow up visits are scheduled with the assumption that everything is going smoothly.  If it's not, your doctor needs to know so you can get the appropriate care.

Trust your gut - a second or third opinion can change - and/or save - your life.  I spoke to a lady who was told her pancreatic tumor was inoperable because it was too close to an artery.  She went for a second and third opinion, and found a surgeon that said he does that surgery several times a week.

As health care is changing, it is more important than ever to be informed and proactive in your treatment choices.

I wish you a happy, healthy and abundant year ahead!

The Oncology Oracle Speaks

 I was so fortunate that my oncologist had an opening first thing Monday morning.  The waiting is the worst of any of these processes.  The data and opinions I’ve been accumulating over the past month gave me valuable perspectives I would not have otherwise considered.  It’s important to follow your gut, but equally important to know that the gut and brain are closely connected.  The more relevant information I have, the more reliable my gut will be.

Here’s some of what we covered, and other tidbits I’ve collected:

What lowers my risk factors:

• I did not test positive for BRCA genes
• Keep my vitamin D levels in a high zone (50-60)
• I finally got my lazy butt up and participate in a regular exercise program.  VERY important, by the way.
• No family history of breast cancer. Although the majority those diagnosed have no family history.
• Normal weight (took off 20 lbs post-chemo)
• Minimal alcohol intake.  Maybe 1-2 glasses of wine a week.  For the most part, it just doesn’t taste as good any more.

What increases my risk: 

• I have breasts.
• I’m female
• Increasing age – as of next week I’ll be over 60
• A personal history of breast cancer
• Radiation exposure – damned if you do, damned if you don’t
• Beginning your period before age 12 (I was 11)
• Beginning menopause after age 55 (I was 58)
• Postmenopausal hormone therapy: 3 months of bio-identical, but messing with nature nonetheless

What could reduce my risk:

• Keep exercising.
• Move to another planet
• Arimidex and similar aromatase inhibitors – these are out of the question for me; the pain was debilitating.
• Tamoxifen:  I’ll be doing a lab test to determine if tamoxifen will be effective for me.

Here’s the thing when they say these drugs “reduce your risk by [60%, 70%, etc.].  That is the percent of the percent of your risk.  So if you have a 2% risk of getting breast cancer, taking a drug that reduces that risk = 60% x 2% = your risk is now 1.2%.

On the other hand, there is a significant increase in the percentage of women taking Tamoxifen that develop uterine cancer. In this 2008 study, it increased the risk 3:1 compared to women not taking Tamoxifen.  Is that a risk I want to take?

And let us not forget – no test is perfect; there are always exceptions. Science and medicine are learning processes based on likely outcomes and we are the long term test subjects. For the first 3 years after I found the lump, no one thought it was even enough concern for a biopsy, based on the mammograms, ultrasounds and thermogram.  Much has changed since then, but my first pathology test diagnosed the wrong type of cancer.  This is not unusual.  Prone to Error: Earliest Steps to Find Cancer

(Thanks to Join Our Loop for that link – stop by & visit this dedicated group.)

The bottom line we agreed upon is that I am not the best candidate for a prophylactic mastectomy AND there are no guarantees. 

My insurance does not cover Dr. Hackert, but it does cover the hospital etc., so back to the drawing board and financial planning department.



What is your experience with Arimidex and/or Tamoxifen? Your thoughts on using these?
Have you been through mastectomy, reconstruction or reduction?  What is your opinion?

Arimidex - the Gift That Keeps on Giving

It's been 3 months since stopped taking Arimidex, and there are a few symptoms that linger. I haven't quite put together what aggravates the pain it left in various joints of my arm/hand, elbow and shoulder, but they come and go at what seems to be a random pattern.

So tell me, if you have stopped taking Arimidex -

• Did you take it for the full 5 years, or have to stop early?
• If you stopped before 5 years, how long did you take it?
• Is there anyone out there that had NO side effects with Arimidex?
• How long since you stopped taking it?
• Are you still experiencing side effects?
• Have the side effects become less intense since you stopped? If so, how long did that take?
• Are you taking a different drug, and if so, what?
• If you are not taking a different drug, are you using a natural remedy?
• Did you report your reaction to Arimidex to the FDA?

I'd love to hear from you! Please post your comments below. I monitor them before they go "live" so if you prefer to keep them private, just let me know. Thanks!
12/20/13 Update
How to report side effects to the FDA

Graduation Day & Flash-Free Nights

Yesterday was my 2nd 3-month follow up with the oncologist since I completed the herceptin in September. We were holding our breath on this one, since the cancer markers had risen as of my last visit. Good oncology news with the lab tests: all the blood tests are great, the numbers for the cancer markers dropped back to normal levels, and despite the chemo, radiation and bout with Arimidex, the dexascan shows my bone density has decreased only slightly from pre-treatment levels. I’m nowhere near osteoporosis. If I can get up off my Twitter-butt long enough to exercise on a regular basis, these old bones will be fine. I’ve graduated to the six-month follow up plan!

The best news is that she agreed the Arimidex was not for me, and maybe none of those meds will be. I’ve been off it a month, and although several symptoms are gone, and the joint pain is significantly reduced, it is still there. Now I have this weird stabbing pain in my left hand that only happens after 9 p.m. and lingers until morning.

I had been trying to get through a 15 minute routine on the rebounder, and halfway through it was all I could do to follow with small movements. The pain in my right hand and elbow was severe enough to preclude my lifting a 5 pound weight. By the second week off that wretched drug, I not only got through the full routine without even getting winded, but I did it in conjunction with arm exercises using both weights. I’ve directed my excitement about the increase in my energy and stamina to override how pissed off I am about the insidious side effects. I was down so long with that stuff that I didn’t know what “normal” was supposed to be.

Monday I’ll see the radiologist for that 6-month follow up, a week before my 1 year rad-iversary on St. Patty’s Day. Even though the process was much easier on me than it has been on so many women, cancer treatment is a brutal insult that is imbedded in the memory of my body and soul. Time seems to have passed so quickly, but it feels like I’m still climbing out of an altered state, surprised every time I reach another step towards health that I didn’t anticipate.

There are yet more special events left in the wake of Arimidex: hot flashes and the dreaded night sweats, which had been long gone and didn’t even arise during chemo. During a relentless attack the other night, I remembered someone telling me of a remedy of apple cider vinegar and honey (or maple syrup). I thought the recipe was for 2 tablespoons of each in water, so that’s what I did. Not only did the hot flashes stop within moments, but I conked out for the rest of the night.

I looked up the recipe the next day in a little booklet my mom had sent me about 20 years ago (and I filed away thinking it was crazy). It actually suggested 2 TEASPOONS of vinegar. No wonder I felt slightly queasy. But it worked – really, really fast.

Usually I have several flashes throughout the day, so I dress in layers, starting with sleeveless. By 3 pm the following day I realized I had been working all day in a sweater AND jacket, and had never felt uncomfortable. I’ve continued the remedy several times a day for the past 3 days; I still have them, but they are significantly less frequent and less intense. I passed the info to a friend who is in a constant state of spontaneous combustion, and it’s working for her, too. Bear in mind that both my friend & I are following a pretty clean diet – little, if any, processed foods, lots of fruit & veggies, etc.

The purist recipe is here: http://bragg.com/healthinfo/acvdaily.html
This is an excerpt:
“When you wake up in the morning just make a delicious cocktail using 2 teaspoons of raw, organic apple cider vinegar, and if you need a sweetener, use organic honey, 100% maple syrup, or molasses to taste. If you are diabetic, use the sweet substitute stevia. I recommend you use only distilled water. This "Bragg Healthy Cocktail" is designed to flush out wastes that are clogging the organs of elimination, the bowels, lungs, skin, and the kidneys. Take it at least twice a day, and you will start to see changes like increased energy, soft skin, and decreased muscle and joint aches from exercise. Make sure you use raw, organic vinegar, never dead, distilled vinegar because the natural enzymes, minerals, and nutrients are destroyed in the distilling process. Any vinegar that is clear and has no "mother" (the strand-like substance in the bottom of the bottle) has no nutritional value. Natural raw vinegar should be pungent, with a rich, brownish color and a visible "mother." Drinking apple cider vinegar daily, and eating a largely fresh, organic, vegetarian diet, along with following a simple fitness program, will change your life so dramatically you will never go back to your old ways!”

Mr. Bragg is a character, and claims it will cure everything, and the book made lots of unsubstantiated claims. It does not mention hot flashes, so I don’t know where I heard that tidbit, but I will say it helped lower the heat!

I do like their products, which you can get at most health food stores. I have been using the Bragg’s Aminos for years and it is delicious; I use it just like any other soy sauce as a seasoning, and always spray it on my salads.

If you have hot flashes and try this remedy, please let me know – did it work for you?
In the meantime: What do YOU do for hot flashes?

Adventures with Arimidex

If you are new to this blog, or one of the angels that has been following on the carepages, welcome. Be assured that none of my rantings are complaints; I’m delighted to be alive, regardless of what it took to get me here. Nor is anything here to be construed as medical advice. I am a breast cancer survivor that happens to be a chiropractor and perpetual student, which gives me access to resources that may not be in the forefront of the news. My purpose in documenting this journey is to encourage your own research and remind you that you are not alone when, for example, your fingernails suddenly shred to the quick.

I love my oncologist. She timed each segment of my treatment to allow adequate recovery in between, and always gives me fair warning about the next step. Then she guides me into doing it on schedule while still letting me feel I have some control in the matter. That’s a warm fuzzy for a control freak, even if is an illusion.

My chemo cocktail was Taxotere/Carboplatin/Herceptin. I completed the first two in December ’08, but as a gift that keeps on giving, the after effects of Taxotere still continue to be achy feet and joints, especially first thing in the morning. Those were quickly relieved by just moving around, and the more I exercised, the better I felt. It was just weird to feel like my joints had suddenly aged 30 years.

Months ahead of her writing the prescription for Arimidex, she interjected the topic into each of our conversations, adding a little more detail each visit. Before my BC diagnosis, I rarely took prescription meds, and used over the counter (OTC) stuff so infrequently that it expired between uses. She knows and respects that taking any meds is a big deal for me. When I finished my year of Herceptin in September 2009, it was “time” for Arimidex. She patiently watched me dance around it for weeks with excuses to postpone the start date.

Both Tamoxifen and Arimidex are drugs taken for about 5 years after finishing chemo for breast cancer. They block estrogen receptors, a good thing if the tumor is “ER+” (estrogen receptor positive), which mine was. An oversimplified explanation of the differences between the two is that Arimidex is typically for post-menopausal women with early stage breast cancer, and Tamoxifen is for premenopausal women (thereby inducing premature menopause). For a more detailed explanation, there is a link to an expert at the end of this post.

Back to the matter at hand.

The list of “common” side effects of Armidex (they occur in 10-20% of patients) made chemo look like a picnic. Once I started taking the drug, I found that they can happen quickly. On the upside it significantly decreases the chances of breast cancer. Hopefully, that would not be due to a side effect killing me sooner. After a week of pretending I forgot to take it, by the beginning of October I ran out of excuses.

Because I was concerned about nausea or anything that would prevent me from working, I waited until a Friday night to take the first pill. I collapsed on the couch, waiting for my eyeballs to bleed and my feet explode. Nothing happened.
Within minutes there was an unfamiliar pressure in my head, similar to the onset of a headache, but I was fine by morning. That symptom still occurs frequently, but not enough to concern me.

Much to my surprise, over the next 2 days my skin looked surprisingly clear (the last herceptin infusion resulted in massive outbreaks). Or maybe the Arimidex severely affected my eyesight? My thoughts were more focused, my energy increased, no aches or pains. I even went for a walk/run and actually looked forward to it... for someone who hates to exercise, I felt this was a bonus.

About a week later, my fingernails started shredding like they did during chemo. I woke one morning with the feeling of an ice pick in my low back. I attributed it to maybe sitting too long or wearing the wrong shoes the day before. I did a few stretches, hobbled around and got on with the day. As it became worse over the following week, I made several visits to my chiropractor. I also have a multitude of effective modalities in my own office, and tried them all. I used cold laser treatments, my usual natural remedies, laser acupoint therapy. I finally succumbed to a few doses of Advil. Not only did nothing relieve it, but it continued to get worse and the pain kept me awake every night. By the end of the second week I wondered if the cancer had metastasized to my spine.

I called the oncologist’s office; they assured me that pain was a common side effect. It would diminish over time and if needed, they would prescribe… forget it. Every prescription pain killer gives me hallucinations, and not the fun kind. Even Advil or Aleve leaves me groggy. I stopped taking the Arimidex and within a few days the pain diminished.

Faced with the dilemma of jumping back into hell, I took dosing matters into my own hands and bought a pill-splitter at CVS. It took a couple of weeks and a few more chiropractic adjustments before the pain went away. At that point I went back on Arimidex at ½ dose for the first week, then full dose, and to this date, the pain has not returned.

After about a week, my thoughts became… negative. Not depressed or teary, but almost. Internal chatter about being a loser came out of nowhere and filtered my outlook. I started snapping at Dave, which is WAY out of character. We have such a blissful relationship that it tends to annoy a lot of people. Once I realized this sudden change was just a side effect, I was able to redirect my thoughts and improve my attitude. But its onset was so insidious that I can understand how it could easily lead to depression.

Oh yes, hot flashes. Long gone, they returned with a vengeance. Not the constant drenching kind, but enough to be aggravating during the day and keep me awake at night. Another side effect of Arimidex is insomnia, but the hot flashes are so prominent at night that I can’t distinguish if I would be able to sleep otherwise. I can work around pain, but I can not tolerate sleep deprivation. It leaves me foggy and disoriented, affecting my decision making and communication abilities, and overall unraveling my life.

During chemo, I never used the collection of anti-anxiety meds that were prescribed in anticipation of their need. But I remembered that one med had a dual use of anti-nausea and insomnia relief. Reluctantly, after trying herbal and supplement formulas that work in normal circumstances, I found I need the 1mg of Lorazepam to get a good night’s sleep without the hot flashes waking me. It’s not so bad; if I do have to get up during the night, I easily fall back to sleep, and never feel groggy the next day.

The challenge with natural remedies is that they can face an uphill battle against the unnatural pharmaceuticals, but that is another topic. I still don’t like having to take anything, so acupuncture is on the list as soon as my budget allows. I’ll keep you posted.

Two weeks into the second round of taking the full 1 mg dose of Arimidex, a migraine started mid-afternoon. My only history of migraines is on the rare occasions when I didn’t eat on time. Since I learned to balance my blood sugar, it happens only a few times a year, and goes away with a nap. This migraine was relentless for the next 30 hours. That night I did not take the Arimidex, and it went away within a couple of hours.

A few days later, I noticed a twinge in my right shoulder when I reached back into the console for the garage door opener. It was not relieved by chiropractic or any of the previously mention remedies, modalities, or non-prescription pain relievers. As the pain progressed, simple reaching and lifting became difficult. I stopped taking it about a week ago, and within 24 hours the pain was down nearly 50%. It’s almost gone now; I only noticed it during a yoga stretch yesterday. To get rid of the last bit of inflammation I’ll start with the natural stuff, and if needed, an OTC once or twice. As soon as I can do those movements without pain, I’ll be back on a ½ dose and work up to the full dose again.

I’m learning to pick my battles to manage symptoms. Over the past 18 months, many angels in human and other forms have inspired me to find solutions along the way. Some worked, some did not. I took a MacGyver-like approach to many of the surprises that arose, and came out the other side with a big sigh of relief. As much as I used to avoid exercise, now it is a necessity or my joints will lock up. I take a variety of supplements (including MCHC calcium and high doses of vitamin D) monitor my vitamin D levels with my other quarterly blood tests, and I’m due for another dexa scan to make sure the Arimidex is not disintegrating my bones.

Below is a list of Arimidex side effects. I do not suggest you do what I do. Every cancer is different, every person responds differently to any given treatment or illness. But knowledge is power. Being aware of the possible symptoms can give you more control by knowing what to monitor, what to ask your doctor, what choices to explore. If you do have side effects, please report them to your doctor as well as the FDA at FDA MedWatch.

If we don’t speak up, they don’t know. I am not anti-drug. I am anti-drugs-that-do-more-harm-than-good. A couple of paragraphs of resources follow; please share your story by clicking on “Comments.” Be well.

Common side effects of Arimidex include hot flashes, weakness, joint pain, pharyngitis (sore throat), hypertension, depression, nausea, vomiting, rashes, back pain, insomnia, headaches, coughing, shortness of breath and swelling of the lymph nodes or extremities…. asthenia (lack of energy & strength), arthritis, pain, fractures, back pain, pain, headache, bone pain, increased cough, dyspnea (shortness of breath), and lymphedema… onset of osteoporosis… increased cholesterol levels.
Other risks include severe allergic reactions, heart attack, stroke and liver dysfunction.
Serious adverse reactions with ARIMIDEX occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face, lips, tongue, and/or throat. This may cause difficulty in swallowing and/or breathing; and 3) changes in blood tests of the liver function, including inflammation of the liver with symptoms that may include a general feeling of not being well, with or without jaundice, liver pain or liver swelling.

My favorite site for more-than-you’d-ever-want-to-know-about-your-meds is rxlist.com, where you can find side effects, drug interactions, details of the studies, comparisons with Tamoxifen and post-marketing info – the stuff they find out AFTER the drug is released upon us.

For a simplified explanation, here is a link to an excellent article: Antihormonal Therapy for Breast Cancer

What have been YOUR adventures with Arimidex?