Medication Monitor

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  • August 20, 2018

    FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API because of inconsistent quality of the API. FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015.

    This thyroid API comes from porcine (pig) thyroid glands and is used to make a non-FDA approved drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism.

    FDA laboratory testing confirmed the Sichuan Friendly API has inconsistent levels of the active ingredients – levothyroxine and liothyronine – and should not be used to manufacture or compound drugs for patient use. Risks associated with over- or under- treatment of hypothyroidism could result in permanent or life-threatening adverse health consequences.

    FDA placed Sichuan Friendly on import alert 66-40 on March 22, 2018, based on current good manufacturing practice (CGMP) deviations observed during an FDA inspection.

    However, FDA confirmed Sichuan Friendly’s thyroid API remains in the U.S. supply chain. Sichuan Friendly API may be repackaged and/or relabeled before it is further distributed, and not all of the repackaged/relabeled API identifies Sichuan Friendly as the original API manufacturer. Therefore, manufacturers and compounders who make levothyroxine and liothyronine drug products should contact their API supplier to verify the actual manufacturer of the thyroid API they received before using it. Sichuan Friendly’s products may be labeled as “Thyroid Powder” or “Thyroid Powder USP.”  

    In addition, manufacturers and compounders who have received API made by Sichuan Friendly should quarantine the API and associated drug products. If manufacturers and compounders have API or drug products made from Sichuan Friendly API, FDA requests these companies contact FDA’s regional offices.

    FDA recommends patients talk to their health professional before they stop taking their combination levothyroxine and liothyronine thyroid medicine. FDA also recommends that patients discuss FDA-approved hypothyroidism treatment options with their doctors, as combination levothyroxine and liothyronine products are not FDA approved.

  • August 20, 2018

    FDA has updated the prescribing information for pembrolizumab and atezolizumab to require use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. Two different companion diagnostic tests were approved by FDA, one for use with pembrolizumab (Dako PD-L1 IHC 22C3 PharmDx Assay [Dako North America]) and one for use with atezolizumab (Ventana PD-L1 [SP142] Assay (Ventana Medical Systems)].

    The second-line indications in urothelial carcinoma for both drugs remain unchanged.

    The tests used in the trials to determine PD-L1 expression are listed in Section 14 of each drug label.

  • August 20, 2018

    Westminster Pharmaceuticals is voluntarily recalling all lots of levothyroxine and liothyronine thyroid tablets in strengths of 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg.

    These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.

    To date, Westminster Pharmaceuticals has not received any reports of adverse events related to this product.

    Because these products may be used in the treatment of serious medical conditions, patients taking the recalled medicines should continue taking their medicine until they have a replacement product.

    The products subject to recall are packed in 100-count bottles.To best identify the products, see this table.

  • August 20, 2018

    FDA has approved a novel, extended-release formulation of methylphenidate for the treatment of ADHD in patients aged 6 years and older. It is taken once daily in the evening at 8:00, instead of immediately upon waking, to provide early-morning symptom control.

    Timing of administration may be adjusted between 6:30 p.m. and 9:30 p.m. to optimize the tolerability and the efficacy the next morning and throughout the day.

    Effectiveness of methylphenidate was established in two separate Pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled studies conducted in a total of 278 pediatric patients aged 6 to 12 years with a diagnosis of ADHD per DSM-5 criteria.

    In addition to the traditional scales that assess efficacy in ADHD clinical trials, such as the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale and the ADHD Rating Scale (ADHD-RS-IV), Ironshore’s pivotal trials assessed methylphenidate's efficacy in the early morning period using the morning subscale of the Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) scale and the Before School Functioning Questionnaire (BSFQ).

    Ironshore plans to make the drug available commercially in the first half of 2019.

  • August 20, 2018

    Vertex Pharmaceuticals announced FDA approval of lumacaftor/ivacaftor to include use in children aged 2 through 5 years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first medication approved to treat the underlying cause of CF in this population. 

    The oral granules are available in two dosage strengths—lumacaftor 100mg/ivacaftor 125mg and lumacaftor 150mg/ivacaftor 188mg—for weight-based dosing.

    FDA approval for this indication was based on a Phase III open-label safety study in 60 patients that showed treatment with lumacaftor/ivacaftor was generally safe and well tolerated for 24 weeks, with a safety profile similar to that in patients aged 6 years and older. Improvements in sweat chloride, a secondary endpoint, were observed at week 24. Researchers also saw changes in key growth parameters, which were also secondary endpoints in the study.

    The most common adverse event (≥30%) was cough (63%); most adverse events were mild or moderate in severity. Four patients experienced serious adverse events (two pulmonary exacerbations, one gastroenteritis, one constipation), and three patients discontinued treatment due to treatment-emergent adverse events or elevated liver function tests. 

    The agent was originally approved for treatment of CF in patients aged 6 years and older who have two copies of the F508del-CFTR mutation.