PHARMACY UPDATE

Nature-Throid® & WP Thyroid® Recall

By Juan Lopez, PharmD, FAPC

Having difficulties filling your prescription thyroid therapy ners may consider if appropriate. NP for Nature-Throid® or WP Thyroid®? Thyroid® and Armour Thyroid® are

RLC Labs, the manufacturer of Nature-Throid® and WP Thy- standardized using a different thyroid roid® products, announced that it is voluntarily recalling all unex- USP quantity as compared to Naturepired lots of Nature-Throid® and WP Thyroid® to the consumer Throid® and WP Thyroid® (60mg vs. level. See RLC Labs’ September 2, 2020 statement below: 65mg). To facilitate patients converting between these different products,

“RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Na- the amount of therapy as grains (gr.) (i.e. ¼ grain, ½ grain, 1 grain, ture-Throid® and WP Thyroid® in all strengths, all counts of product etc.) can be used to express the strength of the patient’s thyroid within current expiry to the consumer level. The products are being therapy and ensure the patient receives the same amount of T3 and recalled because testing of samples from six (6) lots by the U.S. Food T4 supplementation. and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyro- Patients suffering from hypothyroidism symptoms may be sennine (T3) or Levothyroxine(T4). sitive to particular fillers commonly found in medications. Each brand of thyroid medication uses different fillers during the manu-

Risk Statement: Patients being treated for hypothyroidism (un- facturing process. Pharmacists can review inactive ingredients of deractive thyroid), who receive sub potent Nature-Throid® or WP each formulation with patients to help determine tolerability.

Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensi- It is not uncommon that patients who are unable to find their tivity to cold, constipation, dry skin, puffy face, hair loss, slow heart thyroid medication due to availability issues may have their therapy rate, depression, swelling of the thyroid gland and/or unexplained changed from desiccated thyroid, which supplies a standardized weight gain or difficulty losing weight. There is reasonable risk of amount of levothyroxine (T4) and liothyronine (T3), to products serious injury in newborn infants or pregnant women with hypo- that only supply T3 and/or T4 alone. The only commercially availthyroidism including early miscarriage, fetal hyperthyroidism, and/ able T3/T4 combination tablet not derived from desiccated porcine or impairments to fetal neural and skeletal development. In elderly thyroid was sold under the brand name Thyrolar (Liotrix). In Depatients 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 re- Pain Management | HRTports of adverse events related to this recall.

Nature-Throid® and WP Thyroid® (thyroid tablets, USP) are composed of liothyronine and levothyroxine, and are used Prescribe topical medications in Topi-CLICK® 140 to treat hypothyroidism (underactive thyroid).” 0.50 mL

Patients who are currently taking Na- per ture-Throid® and WP Thyroid® should not CLICK discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription. You • Accurate, metered dose without losing prime like pumps are encouraged to contact your prescribing health care provider to discuss next steps. • Innovative Design is user-friendly for all patients The recall of all lots may lead to a supply shortage of this thyroid therapy. In • 4Port™ for faster dosing of thicker topical medications 2017 patients faced similar shortages of Nature-Throid® and WP Thyroid® due to a world-wide shortage of pharmaceutical grade Thyroid USP. NP Thyroid® (Acella Pharmaceuticals) and Armour Thyroid® (Allergan) are two commercially available Request FREE samples for Patient Trials and the International Journal of Pharmaceutical Compounding Peer Reviewed Accuracy Study: www.DoseLogix.com | 877.870.8448 | info.TopiCLICK@teamtech.com | alternatives that patients and their practitioCopyright © 2020, DoseLogix. All rights reserved.

cember 2018, the Food and Drug Administration (FDA) announced the manufacturer made a business decision to discontinue production of Thyrolar tablets. PERSONALIZED THYROID REPLACEMENT THERAPY

Pharmacy Specialists can help patients and physicians design appropriate thyroid replacement therapy. We stock the pure chemical forms of desiccated thyroid (Thyroid USP), levothyroxine (T4) and liothyronine (T3), so that we can create a custom blend of hormones at an ideal ratio to meet patients’ individual needs and maintain their hormone balance. Desiccated thyroid, levothyroxine or liothyronine can be compounded as single ingredient or combination capsules designed to release immediately or over a prolonged period of time. When we compound customized dosages, we have the ability to omit any problem-causing inactive ingredients such as corn, gluten, starch, soy or animal by-products and substitute with non-reactive fillers.

Commercially available thyroid replacement products may not be the best fit for a patient when: (1) There is a lack in availability due to drug shortages. (2) They contain undesirable fillers. (3) They are only available as immediate-release dosage forms. (4) Patients require a different strength than what is available. (5) Patients require a unique ratio of T3 and T4 supplementation. (6) Patients require non-porcine derived products and would benefit from both T3 and T4 supplementation.

When changing thyroid medications from one manufacturer to another, the dose may need to be optimized to meet individual needs, this is also true for a compounded personalized thyroid prescription. We can prepare a variety of strengths and combinations of thyroid therapy providing patients with a larger choice of therapy options. A little more or a little less is no problem based on your symptoms and you healthcare prescriber’s professional judgment.

Our goal as personalized medicine pharmacists is to meet the individual needs and circumstances of patients and physicians. Without the ability to create customized thyroid replacement therapy patients may be at risk for suboptimal or nonexistent thyroid therapy while these medications are in short supply.

REFERENCES AVAILABLE UPON REQUEST.

Juan Lopez, PharmD, FAPC, is a

personalized medicine pharmacist with

Pharmacy Specialists Compounding

Pharmacy in Altamonte Springs, FL.

For more information on how personal-

ized medicine can help you, please call

(407) 260-7002, or email us at Info@

MakeRx.com. 

Check out our newly redesigned website at www.floridamd.com!