Nature Throid Availability 2023

Will Nature Throid be available in 2023? According to the RLC Labs website, “RLC Labs is continuing to work with the FDA to get our products back on the market as soon as possible.” However as of right now, there is no Nature Throid in production. The manufacturer is now selling the active pharmaceutical ingredient, Thyroid USP, which they used to produce Nature Throid and WP Thyroid. That means that patients can get a compounded version of their medication using the same active ingredient that was in these RLC Labs branded medications.

Why are Nature Throid and WP Thyroid Unavailable?

Nature Throid and WP Thyroid have been unavailable since 2021 when there was a complete recall of all lots. This recall was voluntary and initiated by the manufacturer. The recall came after FDA inspections found wider than acceptable ranges in the actual strengths of the finished medications. There is certain variability that is acceptable since the amount of thyroid hormones in a single gland can vary. When a batch is made, there can be +/- 10% of the labeled strength. However once you start getting outside of this range, it is considered unacceptable as the patient may be getting significantly more or less than the expected dose. Inconsistency in dosing can lead to hypothyroid symptoms returning or other side effects.

According to the FDA recall notice (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rlc-labs-inc-issues-voluntary-nationwide-recall-all-lots-nature-throidr-and-wp-thyroidr-current)

Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. RLC Labs, Inc. has not received any reports of adverse events related to this recall.

Nature-Throid® and WP Thyroid® (thyroid tablets, USP) is composed of liothyronine and levothyroxine, and are used to treat hypothyroidism (underactive thyroid). The products subject to recall are packaged in 30, 60, 90, 100 and 1,000 count bottles.

What is Thyroid USP?

When you see the letters “USP” after the name of a drug it means that the drug meets a reference standard established by the United States Pharmacopeia. Nature Throid, WP Thyroid, NP Thyroid, Armour Thyroid, and compounded thyroid all use the same active ingredient – Thyroid USP. There is nothing proprietary about this ingredient. Manufacturers simply change the excipients used to make the medication. Our pharmacy purchases Thyroid USP directly from RLC Labs – the manufacturer of Nature Throid and WP Thyroid when they were available.

Nature Throid and WP Thyroid came in specific dosages that were measured in grains. The grain unit of measurement is not really used anymore but is still used to measure desiccated thyroid products as it was when the products were first made available. However it is still possible to convert grains to a milligram equivalent. This makes it easier to get an accurate dosage when switching to a compounded form of the drug. If you look at the conversion chart on the RLC Labs website here: https://getrealthyroid.com/conversion-guide.html you can see that each grain dosage has an equivalent milligram dosage. When you are sending a prescription to a compounding pharmacy for natural desiccated thyroid, you should use the milligram dosage.

Desiccated Thyroid

There are several synthetic medications on the market for treating hypothyroidism. The typical synthetic medication that is prescribed is levothyroxine (marketed as Synthroid, Levoxyl, Unithroid, Tirosint, and other names). This medication is only one form of the thyroid hormone – T4. There are actually multiple forms of thyroid hormone that affect each other and multiple functions throughout the body.

Desiccated thyroid is actually derived from the thyroid glands of pigs which are dried and turned into a powder that can be used as a pharmaceutical ingredient. This form of thyroid medication has been used for over a hundred years and was the first treatment for hypothyroidism. Desiccated thyroid contains all forms of thyroid hormone including T1, T2, T3, T4, and thyroid co-factors. Patients who report that their hypothyroid symptoms improve more with the use of desiccated thyroid may be improving due to the combination of T4 and T3 with other thyroid co-factors.

These are some key features of Nature Throid according to RLC Labs:

• T4 & T3 replacement hormones derived from natural desiccated porcine thyroid
• Naturally occurring thyroid cofactors T1, T2, calcitonin and iodine (in trace amounts)
• Always gluten-free
• Contains NO artificial colors or flavors
• Contains NO soy, yeast, egg, fish or shellfish, corn, peanut, or rice

Source: https://www.naturethroid.com/

These benefits are the same for compounded thyroid made in a dosage to match Nature Throid or WP Thyroid. The main brands of desiccated thyroid are Amour Thyroid, NP Thyroid, Nature Throid, and WP Thyroid. Most of these have experience recalls or shortages at some point. Usually the reason for the recall is regarding consistency in dosing. A compounding pharmacy can provide desiccated thyroid capsules that do not experience the same kind of recalls as brand-name medications.

Desiccated thyroid was “grandfathered” by the FDA into an approved status, which means it did not go through the traditional FDA approval process. However that does not mean it is not regulated at all or that it can be purchased without a prescription. A prescription is required for all forms of desiccated thyroid including when it is made by a compounding pharmacy. The FDA regulates the production of thyroid to ensure its production meets certain high standards of quality, cleanliness, and consistency. The FDA also regulates compounding pharmacies in general to ensure they meet high quality standards.

Why Do Patients Use Desiccated Thyroid?

As mentioned previously, desiccated thyroid contains all forms of thyroid hormone and co-factors. Synthetic thyroid usually only contains T4. Patients may start their hypothyroid treatment by using levothyroxine and find that they are still experiencing symptoms. For some of these patients, dose adjustments do not work and they look for alternatives. Desiccated thyroid helps some patients who have symptoms that do not improve with synthetic thyroid medication.

One theory is that patients who do better on desiccated thyroid do not effectively convert T4 to T3. T3 is the active form of the thyroid hormone. Taking NDT leads to higher circulating levels of T3 than when taking levothyroxine. The higher T3 levels lead to an improvement in symptoms for patients who have difficulty converting the inactive to the active form of the hormone.

Regardless of what is actually happening with thyroid hormone conversion, patients take NDT simply because it works for them. There are various ways of telling whether a thyroid treatment is working but the best indicator is how the patient feels. Are the symptoms of hypothyroidism being relieved? If the answer is no then there may be medication adjustments, lifestyle changes, or other treatments needed.

Nature Throid and WP Thyroid Availability in 2023

Will Nature Throid be available in 2023? It is hard to say right now but a good guess is that it will not be available at least at the beginning of the year. All lots are currently not in production per the RLC Labs website and there is no indication that the company is going to restart production anytime soon. Until it does become available, RLC Labs is selling Thyroid USP to compounding pharmacies like National Pharmacy so patients can continue their treatment.

Looking to send a prescription for compounded NDT capsules? Contact us here.

Articles

Desiccated thyroid extract compared with levothyroxine in the treatment of hypothyroidism: a randomized, double-blind, crossover study – The Journal of Clinical Endocrinology and Metabolism