Is Your Generic Drug Safe? 


Basically, what is wrong with generic drugs? I'm going to show you a few significant reasons you should take a second look at those generic drugs. 

I recently went to the pharmacy to pick up my thyroid prescription. Along with the prescription I was handed a piece of paper to sign along with the pharmacist telling me that they had changed manufacturers of this particular drug - again. It was THIS time though that he caught my attention and probably because THIS time I was required to sign a piece of paper, which I assume was to release them from any liability. And THIS was when I decided I needed to take a closer look at generic drugs. Here is what I found and what you can do to protect yourself and your family.


Oversight for the manufacturing of generic drugs has huge issues. It has been reported that approximately 80% of the active pharmaceutical ingredients in generic medications are actually made in other countries. Along with that we are told that 40 to 60% of these pills are assembled in another country. What does this mean for you? It means that an enormous number of ingredients are being made in chemical companies that have never been nor ever will be inspected by the FDA. Although the FDA has recently pulled several drugs off the market there are many drugs that are obviously not even being checked. In October 2012 the FDA pulled Wellbutrin (specifically Budeprion XL 300 mg) off the market because it was found to not be "bioequivalent." The United States Food and Drug Administration (FDA) has defined bioequivalence as, "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." Again in November 2012 a generic for the common medication Lipitor was recalled after it was discovered there were tiny particles of GLASS in the bottles. This recall included hundreds of thousands of bottles. Tiny particles of glass - seriously?! 


Once a patent on a pharmaceutical drug expires the components are revealed but pharmaceutical companies are not required to reveal the exact manufacturing processes involved. The FDA standards simply require the new generic drug to "perform in the same manner" as the original drug. However there is a large gap allowed in the manufacturing of generic drugs with a maximum concentration of an active ingredient being allowed to be not less than 80% below or 25% above the original medication's concentration. So, basically, your generic drug could be 20% less effective or even 25% above the original safe dose determined in preapproval status. One study in particular by researchers at the University of Utah discovered that patients diagnosed with atrial fibrillation who switched to a generic form of warfarin (popular blood thinner) after taking the brand-name version Coumadin, or vice versa, experienced a greater risk of bleeding problems. Obviously with some drugs, absorption can make a very big difference in the outcome. This is a concern always in those drugs with a narrow therapeutic index between the amount that has a therapeutic effect and the amount that can have a toxic effect.This large gap results in very real issues when we're talking about generic drug substitutes for thyroid disease, blood thinners, seizure meds, and or heart problems - to name just a few.


It is estimated that nearly 80% of all prescriptions are filled with generic drugs. This is a good thing if we're only talking about saving money. And in the USA we spent $192 billion in 2011 alone on generic substitutions.  Obviously, the main issue is that insurance companies will only reimburse for the cost of generic drugs if there is a generic available. And those individuals who don't have insurance coverage will certainly opt for the lower price of a generic drug - often much lower in price. Now, if you know me at all, you know I am not a fan of pharmaceuticals. However, I do know that there are times when they are necessary and life-saving. But do they REALLY need to cost that much? Another discussion for another day.


1. Make a note of the name of the manufacturer of your generic drug. Some pharmacies print the name on the bottle - mine didn't. I had to call to find out the name of the previous manufacturer as well as the present manufacturer. 

2. Use pharmacies you know you can trust. My pharmacy has made numerous errors from small ones to quite big ones. We should have changed pharmacies years ago. We are now. And the pharmacy we use is a big one in this town. Be very careful buying drugs online or from catalogs. 

3. Whatever the symptoms are for your particular generic drug, once you change from one manufacturer to another, keep a record of your symptoms and your lab values. There is no regulation requiring a pharmacy to use the same generic manufacturer from one month, year or day to another. They also are not even required to let you know. So either ask or pay close attention to the size, shape and color of your pills. If your pharmacy does tell you they are changing to a different manufacturer, let your doctor know and get your lab levels checked more frequently.

4. I was told that if your generic drug isn't working as it should be for you, you can talk to your physician and he can specify to your insurance company - "no generic allowed" and receive prior approval from your insurance company to cover the brand name drug. Check with your doctor and insurance company. 

5. The FDA does have a website where you can access information about the manufacturer of your generic drug. This is where the FDA shows a continuous update of ratings for approved generic drugs. You can find that here: I think it would be a good idea to check this regularly. 

Of course, I'd rather we didn't have to take pharmaceuticals at all. And that each of us would explore alternatives by looking at herbal substitutes with a proven track record - and believe me there are many available. Or maybe just some lifestyle changes would get us off of that Metformin.

Thanks for listening!