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 3, 2018

    FDA is warning that the antibiotic azithromycin should not be given long term to prevent an inflammatory lung condition known as bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. 

    Bronchiolitis obliterans syndrome is caused by inflammation and scarring in the airways of the lungs, resulting in severe shortness of breath and dry cough. Patients with cancer who undergo stem cell transplants from donors are at risk for bronchiolitis obliterans syndrome.There are no known effective antibiotic treatments that prevent the syndrome, and azithromycin is not approved for this use. It is an FDA-approved antibiotic used to treat many types of infections affecting the lungs, sinuses, skin, and other parts of the body.

    The drug, which has been used for more than 26 years, is sold under the brand names Zithromax and Zmax and as generics by many different drug companies. Pfizer, the manufacturer of brand name azithromycin, is providing a Dear Healthcare Provider letter on this safety issue to health professionals who care for patients undergoing donor stem cell transplants.

    FDA is reviewing additional data and will communicate its conclusions and recommendations when the review is complete. Patients who have had a stem cell transplant should not stop taking azithromycin without first consulting with their health care provider.

  • July 31, 2018

    FDA is moving cesium chloride (CsCl) to the category of bulk drug substances (active pharmaceutical ingredients) that present significant safety risks in compounding. CsCl is a mineral salt that is sometimes taken either orally or by injection by cancer patients who seek alternative treatments; however, no CsCl products have been approved by FDA to treat cancer or other diseases. Use of cesium poses significant safety risks (e.g., heart toxicity) and is potentially associated with death. These events can occur with oral administration and/or injection. 

    FDA intends to take action, such as issuing a warning letter or pursuing a seizure of product or injunction, if it encounters compounding using substances placed in this category. 

    FDA reviewed all adverse events related to CsCl and other cesium salts that were reported to FDA or that were published in medical journals through June 30, 2018. FDA identified 23 reports describing serious adverse events associated with cesium, including heart problems.

    Five reports submitted to FDA and 18 published in the medical literature described patients who experienced adverse events from cesium. Seventeen of those reports were associated with CsCl, compared to 6 with other cesium salts like cesium carbonate. Most patients took cesium to try to treat cancer. The doses described in these cases ranged from 500 mg taken every day to 100 g taken over 11 days. Most reports did not identify where the cesium was obtained. In at least eight of these cases, health professionals measured cesium concentrations in the bodies of cesium users and found measured quantities that were several hundred to thousand-fold higher than normal.

    Reported adverse events included QT prolongation, low potassium, seizures, potentially lethal arrhythmias, fainting, cardiac arrest, and death. QT prolongation was the most frequently reported adverse event. QT prolongation in the presence of low potassium usually improves quickly when potassium is administered, but 9 out of 11 of these patients receiving the potassium treatment either did not respond as well as expected or did not respond at all. Of the remaining two patients, one improved as expected, and one had an unknown response. Three patients were treated with a cesium-binding agent called Prussian Blue and had an improvement in the QT within a few days.

    For others, it took several weeks after the cesium was stopped for their QT prolongation to improve. This is probably because when cesium is taken on an ongoing basis, it leaves the body very gradually and may take from 6 months to 2 years to be eliminated.

    Six deaths were reported with use of cesium. FDA considers two of these deaths to be possibly associated with cesium chloride. The reports for these two deaths described cardiac arrest or arrhythmia occurring during, or within 24 hours of injection, of cesium. Three reports did not describe the cause of death, and one person may have died from advanced cancer and bloodstream infection.