Recall of certain lots of NP Thyroid tablets due to super potency
Acella Pharmaceuticals is voluntarily recalling 13 lots of 30 mg, 60 mg, and 90 mg NP Thyroid (thyroid tablets, USP) because testing found the lots to be superpotent, potentially having up to 115% of the labeled amount of liothyronine (T3). The thyroid tablets are composed of levothyroxine and liothyronine. The recalled products are packed in 100-count bottles, and affected lots were distributed nationwide to Acella Pharmaceuticals' direct accounts.
Patients being treated for hypothyroidism who receive superpotent thyroid tablets may experience signs and symptoms of hyperthyroidism, which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, tachycardia, or cardiac dysrhythmias. Pregnant women who take superpotent thyroid tablets may also experience negative maternal and fetal outcomes, including miscarriage and/or impairment to fetal development.
Acella Pharmaceuticals has received two reports of adverse reactions known to be related to the recall.
FDA approves BLENREP for relapsed or refractory multiple myeloma
GlaxoSmithKline plc announced the U.S. Food and Drug Administration (FDA) has approved BLENREP (Belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monocolonal antibody, a proteasome inhibitor and an immunomodulatory agent.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. BLENREP is the first anti-BCMA (B-cell maturation antigen) therapy approved anywhere in the world.
Drug approved for management of heavy menstrual bleeding associated with fibroids
The FDA approved AbbVie's oral estrogen/progestin combination drug consisting of elagolix, estradiol, and norethindrone acetate (Oriahnn) for the management of heavy menstrual bleeding associated with uterine leiomyomas in premenopausal women. Although there are various nonsurgical therapies for fibroid-related heavy bleeding, the drug is the first FDA-approved treatment option for these patients.
Oriahnn must be dispensed with a patient medication guide. The drug may cause bone loss over time, and the loss in some women may not be completely recovered after treatment ends. In addition, the product should not be taken for more than 24 months.
The most common adverse reactions of Oriahnn reported in clinical trials include hot flushes, headache, fatigue, and irregular vaginal bleeding. Labeling contains a boxed warning about the risks of vascular events (strokes) and thrombotic or thromboembolic disorders (blood clots)—especially in women at increased risk for these events. Oriahnn is contraindicated in women with a history of or current blood clots and in women at increased risk for blood clots, including women over 35 years of age who smoke or women with uncontrolled hypertension.
Dupixent approved for pediatric patients with atopic dermatitis
The FDA expanded the approval of Dupixent (dupilumab) to include pediatric patients ages 6 to 11 years old with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent was previously approved for this indication in patients 12 years of age and older.
Dupixent is an interleukin-4 receptor alpha antagonist also indicated for use as add-on maintenance treatment in patients age 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma and as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis.
Dupixent is a product of Sanofi Genzyme Regeneron.