Evaluation of Generic Aromatase Inhibitors

sueinfl

Has anyone read any reports concerning the quality of generic aromatase inhibitors? I have read post after post from people who have experienced extreme differences in side effects depending on the lab that has produced the particular aromatase inhibitor. When I search google or pubmed on this subject, all I find are studies concerned with the difference with copays and that effect on compliance.

Years ago, I was faced with having to give up the use of Welbutrin when my insurance refused to reimburse for the brand name when the generic came out. They stated that it was equivalent. Years later, it was finally determined that it was NOT equivalent when particular labs produced their own formulas.

What can we do to advocate for reviews/studies on the efficacy of the generic versions of anastrozole, letrozole, etc. and the release of what formulas the labs are using? What if, instead of stating that we, the patients, are failing the treatments, the treatments themselves are not what they say they are to begin with?

I am frankly tired of (small) studies that imply that side effects are affected by our preconceptions (all in our heads) and the severity of the side effects dismissed. There is a reason that non-compliance rates range from 50% to 70% when these drugs are all that stand between many of us and progression of bc. It would be criminal if the cause of that non-compliance was that the chemicals we are being given are not what they should be.

Excuse the rant. Too many nights of too much pain and insomnia, despite anti-inflammatory diet, exercise, fish oil, omega 3s, tumeric, etc. Time for more ibuprofen and the treadmill.

Sue

newfmama

Sueinfl, interesting topic. I seem to recall there being a similar discussion about Tamoxifen a few years ago. I did notice different side effects depending on the manufacturer.

I, too am so tired of reading studies & stories that the side effects aren't that bad or minimal, blah, blah, blah. You can read thousands of comments on this forum where woman are debilitated from the side effects of both Tamoxifen & AI's. As you stated, huge percentages of these women quit taking it.

I just found out that essentially I will need to take an AI the rest of my life. I'm 59 but feel like 80 most days. I've tried all the dietary, supplements & exercise recommendations also. If I don't take acetaminophen or ibuprofen, I never get a decent nights sleep.

It appears we have a similar type of cancer.

I pray some research comes up with better treatment.

De

Myraknits

Hi all, I'm done with all the heavy stuff; chemo, surgery and rads and I'll continue targeted therapy every 3 weeks till next March but what I didn't realize until I picked up my rx today was that I'll be on an AI for the next 5 years. My MO never mentioned anything about it when I saw him 2 days ago and just called it in to be filled with no explanation. I'll save my rant about him for another day.

My main concern is reading that Arimadex can cause side effects to the heart. I already have an arrhythmia and really don't need to make it any worse. I have a call into my cardiologist to see what he says but I'm wondering if anyone's developed heart related issues.

MameMe

Great and clear message, Sue. This issue is important to me also. How can data from those who use these meds get collected and organized in a useful way? You have gotten me thinking.

All best, Mame

ChiSandy

What the insurers, pharmacies, and generic mfrs. don’t want you to know is staggering. Despite their assurances (especially those by cheap-@$$ insurance & Part D carriers) that the only difference between a branded drug and its generics is price, name and appearance—or that all generics are alike—the truth is that a generic drug need contain only 75% of the active ingredient in the original patented brand, and that inactive ingredients (binders, fillers, colors, coatings) can vary wildly among all versions of a particular drug. For one of the AIs, letrozole, the version with the fewest inactive ingredients is not the branded Novartis Femara, but Roxane. Next comes Femara, then Teva. Not surprisingly, side effects seem to be mildest with these three letrozoles, with Roxane the gentlest (and cheapest).

Why do inactive ingredients make such a difference? Because binders, coatings and fillers can contain allergens, and colors and excipients contain pigments, minerals and mineral salts to which many people are sensitive. A lot of the symptoms of these sensitivities are remarkably similar to the drug’s side effects—which when added together intensify the side effects.

For letrozole, Roxane tends to be the cheapest and most easily tolerated (or least troublesome), which is the exception to the rules that generics are always less-well-tolerated, and the best version is actually the cheapest. If my pharmacy can’t get Roxane, I have it order Teva. (Novartis Femara is $2700 for a three month supply in U.S. pharmacies and $588--Novartis UK--at Canadian online pharmacies). The larger chains (Walgreen’s, CVS, Costco) and mail-order pharmacies refuse to let me specify which generic I will accept, and they usually stock Accord, Sun or another mfr. with a long laundry list of inactive ingredients.

My husband is a cardiologist and he says that of all generic formulations of various drugs he prescribes, his patients seem to like Teva. But that isn’t necessarily so across the board. A few years back, Teva’s version, called “Budeprion," of bupropion (the generic name for Wellbutrin) was recalled for causing more seizures and suicide attempts (uncommon but known side effects). The difference? The suicide attempts were due to Teva’s version being less effective—turns out it had less than 75% of the amount of bupropion in Wellbutrin; the seizures were due to Teva’s having yellow pigments and being uncoated, whereas Wellbutrin was coated, round and white. (Teva’s was also football shaped and had a foul taste).

sueinfl

Thanks, everyone!

De, funny how we assume 80 should feel bad. My mom-in-law just passed at 94 and she was active without pain up until her heart gave out. If you are interested, there is a facebook group for ILC. Just go to fb search, type in lobular and you should see it pop up. Just ask permission to join and JohnSmith will sign you up. :-)

Myra, I found an related article on the effects of AIs on cardiac function. http://www.medscape.com/viewarticle/790774 There is some increased risk, but, fortunately, not greatly increased. Still, it is something you want your docs to watch. I am glad you did not get doxorubicin which is very cardiotoxic. Congrats on getting through all that you have!

Mame, I appreciate any ideas you can generate. There is a company called ConsumerLab to which I subscribe. They evaluate supplements, herbs, vitamins, etc. for their content, efficacy and purity. I have asked if they would look into aromatase inhibitors, but have not heard back, yet. Perhaps studies can be designed with different groups of women blindly assigned different generic versions of anastrozole and letrozole.

My major concern is what you addressed, Sandy. What exactly are the companies using in their formulas? Can these formulas be verified by independent testing labs? Can women who have had recurrences despite early detection trace their AIs back to a particular lab? The same for women with Stage IV who experience progression.

I am waiting on a second evaluation of my two previous PET/CT scans for progression. If NED, I will be looking into clinical trials for vaccines. If there is progression, I will be looking for clinical trials using immunotherapy. My biggest motivator (besides a longer lifespan) is the hope of getting off of AIs.

Sue

ChiSandy

Update: Roxane Labs was bought by another company which has decided to stop making letrozole. And my pharmacies can no longer get Teva letrozole—only Accord. (I guess all pharmacy chains use the same distributor). My side effects—specifically joint & muscle pain & trigger fingers—have worsened over the last 3 months, which coincides with my switch to Accord. I might just have to suck it up and take Novartis UK Femara and order more from CanadaDrugs.com, going completely out of pocket because Humana (my Part D carrier) has twice denied my MO’s & cardiologist’s requests for prior approval. $600/3 mos. I can handle, especially if it doesn’t kick me into the Medicare “donut hole” of which I might not climb out before the end of the year.

sueinfl

Sandy, I am really sad to hear that. With all the side effects some of us have to deal with, anxiety over the quality of our drugs shouldn't be one of them. I hope you can find a version that works better for you. Would anastrozole be a possibility? Letrozole "outperforms" it, but not by that big a margin.

My latest situation is over pain management for even the Teva letrozole. I have spent years eating an anti-inflammatory diet...high in omega 3's, very limited processed food, organic protein 90% of the time, etc. I exercise every day to keep the joints warmed up and fight the fatigue. I have tried just about all the NSAIDs including celecoxib. The only thing that gives me relief is 5 mg vicodin and I only need it at night so I can sleep. I can muscle through the pain and discomfort during the day without anything, but it keeps me from sleeping more than an hour or two and not soundly.

I don't like being dependent upon any drug, but since I am dependent upon letrozole at this point, I accept the vicodin as a necessary evil. The tough part I am dealing with is seeing article after article every day about the opioid crisis and the crack down on users. That and my PCP's hating prescribing the drug. The constant battle has about worn me out to the point of giving up the letrozole and letting the chips fall.

Thanks for letting me whine.

Sue