Saturday, September 22, 2012

A New Generic!

I won't be fully discussing Actos for a few more weeks, but I wanted to let you know that it is now available as a generic! What does this mean? Lower price for the same medicine!

You can access the article here.

The generic for Actos, pioglitazone, has now been approved by the Food and Drug Administration (FDA) for sale within the United States. You see, when medications first come out for use in the US, they can only be produced by one company. The company that spent the money developing the drug and applying for approval by the FDA is allowed to market their drug exclusively for a certain amount of time, under a brand name. After a certain number of years, this patent expires and other companies can apply to the FDA for approval of their generics to the original drug.

Many patients do not have a full understanding of generic medications. I have many customers that will only buy brand name medications because their belief is that generics are inferior products. And I can understand the confusion. Think about it, you buy store brand facial tissue and it doesn't ever seem to hold up as well as Kleenex, does it? Generic cereal never tastes the same as the brand name product, right? In these cases, generic sometimes signals "low quality."

This isn't the case with medications. The FDA requires all generic medications to be held to as high of standards as brand name medications. They go through an approval process that requires manufacturers to prove that the drug in the generic product is the same as in the name brand. The active ingredient, the "drug," must be identical chemically in both products.

The next time you are in the store, pick up a box of Aleve and a box of its generic "naproxen". Turn to the part where it lists the active ingredients. On both, you will find the words "naproxen sodium 220 mg." This is the main ingredient, the drug that is helping with your pain. Your generic facial tissue company can use as much or little paper to make their product as they want, but if a box says it is generic for Aleve, it will have 220 mg of naproxen in it.

You will notice that the inactive ingredients might be a bit different between the two boxes. Inactive ingredients are basically just fillers - they give the tablet its shape, color, and form. They are considered inactive because they do not do anything to change how the active ingredient, the naproxen in this case, works. Each company uses different fillers to make their tablets, but they don't affect how the medicine works. If they did, they would not be approved by the FDA as a "generic" product.

The most important thing to know is that all generics, before being sold in the US, have to be proven to be equivalent to the original brand name product. They can't work "almost as well" as the original - the makers of the generic have to show that they work the same way as the original. The same amount of the drug must reach the patient's blood in the same amount of time in both the name brand and generic for it to be considered equivalent. The generic has to be just as strong, pure, and stable (meaning it does not expire any sooner than the brand name medicine sitting next to it in your medicine cabinet) as the original brand name drug, or it will not be approved.
If you want to read more about what the FDA has to say about generic medications and the approval process, there is a wonderful article on their website here.

What I like to remind people is that generics have been around for many years. When you look at a list of the top 200 medications that were prescribed this year, the vast majority of them are generic medications. Chances are, you are currently taking a generic medication on a daily basis and have probably thought nothing of it. Metformin, our drug of choice for type 2 diabetics, is a generic. Most blood pressure medications that we commonly use are generic (lisinopril, atenolol, metoprolol, amlodipine - any sound familiar? all generics). Cholesterol medications are usually generic too (statins such as simvastatin, pravastatin, lovastatin, and the newest generic atorvastatin).

Most insurance companies won't cover a brand name medication once a generic is available, unless your doctor fills out some paperwork stating why the brand name medication must be used. And with the recent recalls of over-the-counter brand name medications such as Tylenol, generics have become the more easily accesible option for many patients. They are less expensive and work just as well as the brand name products.

So patients on Actos, rejoice because there is now a cheaper alternative! If you haven't been switched to the generic yet, talk to your pharmacist about when it might be available to you. Some insurance companies take about a month to six months to officially "recognize" the generic and add it to their plan, so it might take a bit of patience. But soon, you will be saving money and living a better life!

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As a disclaimer, I am your "virtual" pharmacist, here to provide you with information and answers to questions. However, I am not your local pharmacist and could, in no way, be aware of your specific medical needs. Remember to always check with your medical provider and pharmacist before stopping or starting any new medications. My posts are based on general pharmacy principles and should not considered as your "first opinion" when it comes to your health. Please consult with your doctor and pharmacist about anything regarding your health.

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