Acella Pharmaceuticals recently recalled 35 commercial lots and three sample lots of NP Thyroid medicine after testing revealed sub-potency of the medication prescribed to treat underactive thyroids. Testing discovered that the recalled lots had less than 90% of the active ingredients liothyronine (T3) and/or levothyroxine (T4) as claimed on the bottle labels.
This most recent recall comes after two previous recalls in 2020. The FDA recalled specific lots of NP Thyroid for sub-potency in September 2020. Earlier in May 2020, several lots were recalled for super potency.
In addition, Acella has received 43 reports of serious adverse events that could be related to the latest recall, according to the recall notice via the Food and Drug Administration.
With the sub-potent NP Thyroid medicine, people reported symptoms that 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.
The notice also stated that there is a reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism that could result in early miscarriage, fetal hyperthyroidism, and possible problems with newborns’ nerve and bone development.
Elderly patients and patients with underlying cardiac disease may experience symptoms of hyperthyroidism, including cardiac pain, palpitations, or cardiac arrhythmia.
The FDA recall notice lists the exact lot numbers affected. The lots come in 100-count bottles of 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg strength tablets and seven-count bottles of sample lots of 15 mg, 30 mg, and 120 mg strength tablets.
Understanding Thyroid Medication
Thyroid hormones play a crucial role in regulating various bodily functions. These hormones, primarily thyroxine (T4) and triiodothyronine (T3), influence metabolism, growth, development, and body temperature. Disruptions in the function of the thyroid gland, lead to thyroid hormone imbalances. These imbalances can result in symptoms like fatigue, weight changes, and mood disturbances, impacting the individual’s overall health and recovery.
Thyroid hormone replacement therapy is often crucial for individuals with hypothyroidism or other thyroid conditions to maintain proper bodily functions. When a thyroid medication is recalled due to quality control issues or contamination, it can lead to serious health consequences for patients, including hormone imbalances, exacerbation of symptoms, and potential long-term health risks. These recalls highlight the importance of ensuring the safety and effectiveness of medications, especially those critical for managing chronic conditions like thyroid disorders.
Thyroid Medications Available
Several types of thyroid medications are available to treat thyroid disorders, each with its characteristics and benefits. The most common types include levothyroxine, liothyronine, and natural desiccated thyroid (NDT) hormones. Levothyroxine, such as Synthroid or Levoxyl, is a synthetic form of the T4 hormone and is the most commonly prescribed thyroid medication. Liothyronine, also known as T3 hormone, is available under the brand name Cytomel and is sometimes used in combination with levothyroxine for certain patients. Natural desiccated thyroid hormone, derived from the thyroid glands of pigs, contains both T4 and T3 hormones and is available in brands like Armour Thyroid or Nature-Throid. The kind of medication a doctor prescribes to a patient depends on factors such as the type and severity of the thyroid disorder, patient preference, and response to treatment.
The Role of Medication In Managing Thyroid Disorders
Medication plays a crucial role in managing thyroid disorders by helping to regulate hormone levels and alleviate symptoms. For hypothyroidism, the most common treatment involves hormone replacement therapy using synthetic thyroid hormones like levothyroxine. This medication helps restore the body’s thyroid hormone levels, which can improve energy levels, mood, and metabolism. For hyperthyroidism, medications such as methimazole or propylthiouracil are used to reduce the production of thyroid hormones and manage symptoms like rapid heartbeat and weight loss. Medication is often the first line of treatment for thyroid disorders and is effective in controlling symptoms and maintaining hormone balance.
Recall Alert: Low Potency Danger
On April 30, 2021, Acella Pharmaceuticals issued a voluntary recall of 38 lots of NP Thyroid® (thyroid tablets, USP) available in 100- and 7-count bottles due to subpotency issues. Testing revealed that these lots may contain as little as 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4). Patients who have been prescribed these sub-potent medications may experience symptoms of hypothyroidism, such as fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland, and unexplained weight gain or difficulty losing weight.
There is a significant risk of serious harm to newborn infants or pregnant women with hypothyroidism, including early miscarriage, fetal hyperthyroidism, and impairments to fetal neural and skeletal development. Elderly patients and those with underlying cardiac conditions are also at risk of experiencing toxic cardiac manifestations of hyperthyroidism, such as cardiac pain, palpitations, or cardiac arrhythmia. Acella has received 43 reports of serious adverse events potentially linked to this recall.
What Thyroid Medications Have Been Recalled?
Acella Pharmaceuticals, LLC, has decided to voluntarily recall specific lots of NP Thyroid® Thyroid Tablets, USP, containing 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg of levothyroxine (T4) and liothyronine (T3). This recall, detailed in Tables 1 and 2 in the following FDA recall notice, is being initiated due to routine testing identifying these lots as sub-potent: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-certain-lots-np-thyroidr-thyroid-0
Implications for Patients
Low-potency medications can have significant effects on thyroid patients. For individuals with thyroid disorders, such as hypothyroidism or Hashimoto’s thyroiditis, the thyroid gland’s ability to produce thyroid hormones is compromised. These patients often rely on thyroid hormone replacement therapy to maintain adequate hormone levels. However, low-potency medications, if not carefully monitored, can interfere with hormone absorption or exacerbate existing thyroid dysfunction.
Recognizing signs and symptoms of inadequate thyroid hormone levels is crucial for thyroid patients to prevent potential complications. Symptoms of hypothyroidism, which occurs when the thyroid gland does not produce enough thyroid hormones, include fatigue, weight gain, sensitivity to cold, dry skin, and hair loss. Additionally, individuals may experience muscle weakness, constipation, depression, and memory problems. In severe cases, untreated hypothyroidism can lead to myxedema, a rare but life-threatening condition characterized by extreme hypothyroidism symptoms, such as low blood pressure, decreased body temperature, and unconsciousness. Prompt recognition and management of hypothyroidism are essential to prevent complications and improve quality of life.
Regular thyroid function testing is essential for thyroid patients to ensure optimal hormone levels and adjust medication doses if necessary. Thyroid function tests, including measurements of thyroid-stimulating hormone (TSH), free thyroxine (FT4), and sometimes triiodothyronine (T3), help healthcare providers assess thyroid function and determine the appropriate course of treatment. For example, an elevated TSH level indicates hypothyroidism, while a low TSH level may indicate hyperthyroidism (overactive thyroid). Regular monitoring allows healthcare providers to detect changes in thyroid function early, optimize hormone replacement therapy, and prevent potential complications associated with thyroid disorders.
What to Do If Affected
Both prescriptions and over-the-counter medications are thoroughly tested for safety and effectiveness before doctors can prescribe them to patients. Once on the market, drugs are monitored for unforeseen problems. The FDA will issue a recall when a drug is found to be defective, poses a side effect that was not initially apparent, or may be harmful.
Drug recalls occur frequently for minor problems. Sometimes, medications may contain toxic impurities or incorrect levels of active ingredients, like in this recent case with Acella. Here is how you should handle drug recalls if a medicine you are taking is affected:
- Stop taking a recalled drug immediately. You may be able to return the product to where you purchased it and ask for a refund. Ask the store about their recall refund policy.
- Contact a health professional if necessary. If one of your prescription medications is recalled, call your physician or pharmacist to learn more about a replacement medication.
- Learn more about the recall. Find regularly updated recall information from the FDA on its website and sign up for product recall alerts.
- Safety discard of the recalled drug. See instructions for safe disposal on the medication’s label or package’s patient information. Contact your local pharmacy and ask if they offer a medication disposal service, as many major pharmacies now offer this service.
- Report medical problems to the FDA. After notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
- Explore additional assistance. Dangerous and defective drugs may pose a major product liability issue. Depending on the case, drug manufacturers have been held liable for adverse side effects and found negligent if mistakes occurred during product testing or production.
Manufacturer’s Response
Acella Pharmaceuticals’ response to this recall has been swift and proactive. The manufacturer has communicated directly with patients and healthcare professionals to ensure they are aware of the recall and informed of the potential risks associated with the affected lots of NP Thyroid®.
In response to the low potency issue, Acella Pharmaceuticals has taken several steps to address the situation. The company has identified the specific lots of NP Thyroid® that are affected by the recall and has promptly initiated the recall process. Acella Pharmaceuticals is also working closely with the FDA to investigate the root cause of the low potency issue and to implement corrective actions to prevent similar issues in the future.
The manufacturer has also provided guidance to patients and healthcare professionals regarding the next steps to take in light of the recall. Patients who are taking NP Thyroid® should contact their healthcare provider to discuss alternative treatment options. Healthcare professionals are advised to discontinue prescribing the affected lots of NP Thyroid® and to contact Acella Pharmaceuticals for further information.
Adverse reactions or quality issues while using this product may be reported to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online, by regular mail, or by fax. To submit a report online, patients may visit the MedWatch website.
For regular mail or fax submissions, individuals can download a reporting form from the website or call 1-800-332-1088 to request a form. Once the form is completed, it must be returned to the address provided or submitted by fax to 1-800-FDA-0178. Submitted reports help the FDA monitor the safety and quality of this product.
Patient Advocacy and Support
Patient advocacy and community support play a crucial role in providing emotional support, information, and resources for individuals affected by a thyroid medication recall. These groups can offer a sense of community and understanding, as well as practical advice on managing thyroid disorders during this challenging time.
Online forums and social media groups dedicated to thyroid health, such as those on Reddit or Facebook, can be valuable sources of support and information-sharing. Additionally, organizations like the American Thyroid Association (ATA) may provide guidance and resources for individuals navigating the impact of a medication recall on their thyroid disorder management. These support networks can help individuals affected by the recall feel less isolated and more empowered to make informed decisions about their health.
Prevention and Preparedness
Staying Informed About Medication Recalls
Patients can stay informed about medication recalls by regularly checking the FDA’s website for the latest updates. The FDA provides a dedicated page for drug recalls, market withdrawals, and safety alerts, where patients can search for specific medications or browse recent recalls.
Signing up for email alerts from the FDA can ensure that patients receive timely notifications about recalls that may affect their medications. Pharmacies may also provide information about recalls, so patients should consider subscribing to their pharmacy’s notification service or following them on social media for updates.
Storing Medication Properly to Maintain Potency
Proper storage is crucial for maintaining the potency of thyroid medication. Patients should store their medication in a cool, dry place away from direct sunlight and moisture. The medication should be kept in its original packaging and stored at the recommended temperature, which is usually between 68°F to 77°F (20°C to 25°C). Avoid storing medication in the bathroom or kitchen, as these areas can be too humid. It’s also important to check the expiration date regularly and dispose of any expired medication properly.
Keeping Healthcare Providers Updated on Medication Changes
Patients should keep their healthcare providers updated on any changes to their medication, including recalls or switches to alternative treatments. Communication is key to ensuring that patients receive the appropriate care and monitoring. Patients should inform their healthcare providers about any adverse reactions or changes in their symptoms, as these may be related to changes in medication potency or formulation. Open and honest communication with healthcare providers can help patients navigate medication recalls and ensure that they continue to receive the best possible care for their thyroid disorder.
Conclusion
The effects of various drugs on the body can vary significantly. Factors such as body size, overall health, drug dosage, and the presence of other drugs in one’s system can all influence how a drug affects an individual. It’s important to recognize that the impact of drugs can differ from person to person.
Unfortunately, some medications can be harmful or even fatal. Issues such as improper manufacturing, handling, or labeling can contribute to these dangers. In such cases, manufacturers and sellers may be held accountable for the negative effects these drugs have on health, even if the danger was not initially known or a recall was issued.
At Panter, Panter & Sampedro, our legal team has more than three decades of experience advocating for victims of dangerous drugs and medical devices. If you or a loved one has suffered losses due to a harmful drug, we are here to help. Contact us today at 305-662-6178 for a free consultation to discuss your case.
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