Having difficulties filling your prescription thyroid therapy for Nature-Throid® or WP Thyroid®?
RLC Labs, the manufacturer of Nature-Throid® and WP Thyroid® products, announced that it is voluntarily recalling all unexpired lots of Nature-Throid® and WP Thyroid® to the consumer level. See RLC Labs’ September 2, 2020 statement below:
“RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from six (6) lots by the U.S. Food and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).
Risk Statement: 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) are composed of liothyronine and levothyroxine, and are used to treat hypothyroidism (underactive thyroid).”
Patients who are currently taking Nature-Throid® and WP Thyroid® should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription. You are encouraged to contact your prescribing health care provider to discuss next steps.
The recall of all lots may lead to a supply shortage of this thyroid therapy. In 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 alternatives that patients and their practitioners may consider if appropriate. NP Thyroid® and Armour Thyroid® are standardized using a different thyroid USP quantity as compared to Nature-Throid® and WP Thyroid® (60mg vs. 65mg). To facilitate patients converting between these different products, the amount of therapy as grains (gr.) (i.e. ¼ grain, ½ grain, 1 grain, etc.) can be used to express the strength of the patient’s thyroid therapy and ensure the patient receives the same amount of T3 and T4 supplementation.
Patients suffering from hypothyroidism symptoms may be sensitive to particular fillers commonly found in medications. Each brand of thyroid medication uses different fillers during the manufacturing process. Pharmacists can review inactive ingredients of each formulation with patients to help determine tolerability.
It is not uncommon that patients who are unable to find their thyroid medication due to availability issues may have their therapy changed from desiccated thyroid, which supplies a standardized amount of levothyroxine (T4) and liothyronine (T3), to products that only supply T3 and/or T4 alone. The only commercially available T3/T4 combination tablet not derived from desiccated porcine thyroid was sold under the brand name Thyrolar (Liotrix). In December 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:
- There is a lack in availability due to drug shortages.
- They contain undesirable fillers.
- They are only available as immediate-release dosage forms.
- Patients require a different strength than what is available.
- Patients require a unique ratio of T3 and T4 supplementation.
- 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 an 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.
For more information on how personalized medicine can help you, please call (407) 260-7002, or email us at Info@MakeRx.com.
Originally featured on FloridaMD 24 Sep, 2020