Levothyroxine is a synthetic form of the thyroid hormone thyroxine (T4) that is used to treat an underactive thyroid gland known as hypothyroidism. It is the most commonly prescribed drug in the United States, with nearly 123 million prescriptions in 2016. There is a lot of misinformation about the safety and efficacy of generic levothyroxine versus brand names like Synthroid. Here's what you need to know about taking generic levothyroxine to treat hypothyroidism.
It is equally safe
Generic levothyroxine is as safe as its brand names (in the US they include Synthroid, Levoxyl, Unithroid, and Tirosint) because it has the same FDA-approved active ingredient (levothyroxine). However , some people are sensitive to fillers and additives that contain the inactive ingredients in levothyroxine, such as gluten, dyes, and lactose. If you are unsure of the ingredients in your prescription, ask your pharmacist for a list.
The study, which was presented at the 2017 American Thyroid Association (ATA) conference, examined nearly 88,000 new hypothyroid patients who had just started generic or brand-name levothyroxine treatment. The researchers wanted to study the risk of hospitalization for cardiovascular disease, which is more likely to occur in both hypothyroidism and people taking levothyroxine .
The study found that after one year, both those who took the generics and those who took the brand names had the same risk of hospitalization due to cardiovascular diseases such as heart attack, stroke, congestive heart failure and atrial fibrillation. arrhythmia.
Another notable point is that the majority of patients, almost 71%, were prescribed generic levothyroxine, while just over 22% were prescribed brand names. The researchers also found that more than 60% of the prescribers were primary care physicians, the majority of whom prescribed generics, while nearly 11% were endocrinologists who were significantly more likely to prescribe brand-name levothyroxine .
If you are concerned about cost, a generic version of levothyroxine may be a good option for you. A lot of people take it without a problem, and the cost is about 67% below the average retail price for brands. However, for some people there is a real problem with fluctuations in power (see below) .
Features may vary
A key concern with generic levothyroxine and a valid complaint from healthcare providers is that every time you get an extra dose, you could potentially get levothyroxine from another generic manufacturer. So this can be a problem.
Levothyroxine is legally required to be within 5% of its stated efficacy, and the FDA requires this efficacy to be between 95% and 105%. Each company's formula for a specific dose of levothyroxine is generally the same, so if Manufacturer A's product is typically 96%, it will generally work consistently with an efficacy of around 96%. Likewise, if manufacturer B's levothyroxine in a certain dose generally works at 105% potency, this will generally be permanent.
So, using the example of a 100 mcg levothyroxine tablet, the 100 mcg tablet from drug manufacturer A provides 96 mcg of active levothyroxine. Pharmacist B supplies 105 mcg of active levothyroxine. Moving from manufacturer A to product B, the difference is about 65 mcg per week, which is almost like taking an additional pill each week. On the contrary, if you go from B to A, it is like missing more than half a pill per week.
Because pharmacies can fill generic prescriptions free of charge with products from any manufacturer, unlike brand-specific prescriptions, with each generic levothyroxine supplement, you risk getting a product from another drug manufacturer that uses a different strength . It can affect the stability of thyroid replacement, symptoms of hypothyroidism, and thyroid-stimulating hormone (TSH) levels.
Can minimize fluctuations in power
Some people are not sensitive to fluctuations in potency, while others report unpleasant symptoms when switching brands and generics in one form or another. There is nothing wrong with generic levothyroxine as such; they are as safe and effective as the brands. But if you are taking generic levothyroxine, you will get better results if you learn to minimize the effects of fluctuations in potency .
Get a lot
One way to minimize the risk of a power difference is to get a supply that lasts for a while. For example, ask your healthcare provider to write you a prescription for a six-month supply. Make sure you get a new lot that expires after it is used up.
Work with your pharmacist
If thyroid hormone levels stabilize with generic levothyroxine, find out who the manufacturer is. While your healthcare provider may not prescribe levothyroxine from a specific generic manufacturer, if you have a relationship with a pharmacist, you can specifically request that your prescription be filled with a specific generic that is right for you.
While many pharmacists will work with you to get a prescription from the same generic manufacturer, you can opt for a smaller pharmacy as this can be difficult with larger pharmacies, chain stores, or mail order pharmacies.
This is not the best option if you have thyroid cancer.
Volatile TSH levels, a potential problem if your pharmacy switches to generic levothyroxine from different manufacturers, is especially concerning if you are a thyroid cancer survivor. This patient population requires careful and consistent dosing to suppress TSH as a way to prevent cancer recurrence. If you've had thyroid cancer, talk to your doctor about the pros and cons of taking generics.
Softgels can be a good option.
For several years, a liquid form of levothyroxine in softgel capsules has been available in the United States under the trade name Tirosint. It was primarily developed as a specialized hypoallergenic form of levothyroxine for people who have digestive or intestinal problems, difficulty absorbing thyroid medications, or allergies to fillers and binders in levothyroxine tablets .
The study, which was presented at the 2017 American Thyroid Association conference, compared the efficacy of levothyroxine tablets, a conventional drug, and soft gels in patients undergoing complete thyroidectomy for multinodular goiter. None of the patients had absorption problems.
About half of the patients examined received levothyroxine tablets and the other half received softgel capsules in the same dose beginning with thyroid surgery. The levels of TSH, free thyroxine (FT4) and free triiodothyronine (FT3) of the patients were assessed at six weeks and then at 12 weeks.
At both 6 and 12 weeks, the patients taking the softgel capsule had significantly lower TSH levels, and at both measurement points, the number of patients who had an elevated TSH level above 3, 5 μU / ml (which in this study was considered hypothyroidism) was significantly higher in the group. patients receiving pills. The researchers concluded that even in patients who did not have malabsorption or digestive problems, the softgels were more effective .
Tyrosint does not contain sugars, dyes, alcohol, wheat starch (gluten), lactose, acacia, or any of the other additives or fillers commonly used to make levothyroxine tablets. The only ingredients in the capsules are levothyroxine, gelatin, glycerin, and water, which are unlikely to interfere with absorption or cause allergies. There is currently no generic language available.
Transition from a company name to a universal one
If you're trying to save on costs and want to switch from brand-name to generic levothyroxine, talk to your doctor. At first, you may need to monitor your TSH levels more often until he or she is sure you stay where you need to and have no symptoms. Also keep the tips mentioned above in mind to minimize power fluctuations.
In cases where cost, insurance, or your health insurance plan requires you to take generic levothyroxine and cannot guarantee that you are receiving repeat medications from the same manufacturer, you should monitor your symptoms closely after each dose. If you have symptoms, talk to your doctor about retesting your thyroid level to make sure you are not in doubt due to the different activity of the product.
Transition from generic to corporate name
You may find it difficult to reach your target or optimal thyroid test levels and address ongoing symptoms of hypothyroidism, so you'll want to try a brand like Synthroid. Or maybe you have thyroid cancer or are sensitive to inactive ingredients and want to try Tyrosint.
Due to its status as a specialty drug for a limited audience and because Tyrosint is significantly more expensive than other brands of levothyroxine or generic tablets, it has not been widely adopted for the treatment of hypothyroidism in the United States to date. This means that your health insurance company or HMO may not be willing to pay for this or other brands. In this case, your healthcare provider may need to write a letter explaining to your insurance company why you need a mark.
If you have to pay the difference out of pocket, check out the discounts you can get online, like GoodRx. Also see if you can find coupons or discount programs from the manufacturers of the brand you are researching.
Get the word of drug information
ATA recommends taking the same drug, whether generic or brand-name, throughout treatment to avoid changes in potency. If you've tried generics and found that they just don't work as well for you as a certain brand of levothyroxine, ask your healthcare provider to write you a prescription with a special DAW designation on your prescription, which means' leave as written , ”Along with“ No General Replacement ”. This way, you have a better chance of having your insurance company or HMO prescribe the brand-name drug, as written, without trying to replace the cheaper generic drug.