Characteristics of FDA drug recalls: A 30-month analysis

Hall, Kelsey; Stewart, Tyler F.; Freeman, Maisha Kelly

doi:10.2146/ajhp150277

Cited by 42 publications

(51 citation statements)

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“…There were few publications about drug recalled in different countries and categories, such as the retrospective analysis by Freeman et al [10] that results in a total of 21,120 products which were recalled during the 30-month study period and recalls of cosmetic and personal care products from 2002 to 2016 [10]. Almuzaini et al [26] demonstrate a total of 653 defective medicines in Canada during their study from 2005 to 2013.…”

Section: Discussionmentioning

confidence: 99%

“…Similarly, Hall et al carried out a retrospective study evaluating the relationship between recall companies and medicines recalled by FDA from June 20, 2012, to December 31, 2014. They found that the most common reasons for drug recall were contamination (50.1%) [10]. Also, Almuzaini et al evaluated drug alerts in the UK (2001-2011), they found that contaminations are the most common reasons for drug recall (27%) [25].…”

Section: Discussionmentioning

confidence: 99%

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Medicine recalls in Saudi Arabia: a retrospective review of drug alerts (January 2010–January 2019)

et al. 2020

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Background A new incidence of a substandard medicinal product is discovered weekly as stated by the World Health Organization (WHO) around the world. After discovering an incidence of a substandard medicinal product, a drug recall announced to remove the affected medicinal product from the market. Drug recalls in SaudiArabia (SA) are made by the Saudi Food and Drug Authority (SFDA) or the distributors of the drug when certain criteria are met. A retrospective study of drug recalls in SA was carried out. Data were collected through a website search of the SFDA for drug recalls since January 2010–January 2019. Results SFDA recalled 84 substandard medicinal products which related to 47 alert letters and 52 drugs. The number of drug recall reported by SFDA increased six-folds in 2018 than in 2010. The major frequent therapeutic class of drug recall was the antihypertensive drugs followed by the antibiotic drugs (27.7% and 10.8%, respectively). The majority of the recalls were tablets followed by parenteral dosage forms (58% and 25%, respectively). The major reasons for the drug recalls were due to contamination (32.14%) followed by non-compliance with manufacturer’s specifications (20.48%). Two manufacturers were accounted for 34.52% of all recalled drugs. Conclusion Substandard medicinal products are considered as a serious problem in SA. Contamination was the main cause of drug recalls, which requires root investigation of causes and for strict protective tools to be applied by drug manufacturers.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Medicine recalls in Saudi Arabia: a retrospective review of drug alerts (January 2010–January 2019)

et al. 2020

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“…The most common reason for product recalls is manufacturing issues. An investigation of FDA drug recalls lists contamination, mislabeling, adverse reaction, defective product, and incorrect potency as common causes for recalls [28]. Other causes include regulatory issues, discontinuation of products from the market, procurement issues, business decisions and natural disasters [7].…”

Section: Discussionmentioning

confidence: 99%

Impact of angiotensin receptor blocker product recalls on antihypertensive prescribing in Germany

Rudolph

Enners²,

Kieble³

et al. 2020

J Hum Hypertens

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In Germany, ~8 million patients take angiotensin receptor blockers (ARBs) and 2.25 million of them valsartan. In 2018, contamination of generic ARBs with probable carcinogenic nitrosamines resulted in more than 30 recalls. The impact of such a huge recall has never been explored in Europe. We analyzed the utilization of valsartan, all ARBs, and other alternative antihypertensive drugs in Germany. We used our database of anonymized dispensing data from >80% of community pharmacies at the expense of the statutory health insurance (SHI) funds from January 2017 to December 2019. We analyzed 290.8 million prescriptions, including all oral mono- and fixed-dose combinations of ARBs and plausible alternatives, i.e. ACE inhibitors (ACEi), beta-blockers (BB), and calcium channel blockers (CCB). Utilization was calculated by defined daily doses per 1000 SHI-insured persons per day (DID). Valsartan use decreased substantially after the recalls in July 2018 from 39.0 to 14.2 DID (−64%) in the second quarter of 2019 and to 16.9 DID (−57%) in the fourth quarter of 2019. Simultaneously, the use of alternative ARBs increased from 77.7 DID in the second quarter of 2018 to 121.9 DID (+57%) in the fourth quarter of 2019, mainly due to an increase of candesartan dispensing to 99.8 DID (+73%). There were no changes in the utilization of ACEi, BB, or CCB. The majority of recalled generic valsartan products were replaced by other ARBs, predominantly candesartan, despite documented drug shortages. In contrast to previous safety warnings/recalls, our data do not suggest an under-prescription of antihypertensives during this period.

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“…the lack of retesting incoming bulk ingredients), batch consistency, shelf-life, and microbial contamination [ 49 , 50 ]. According to a retrospective analysis of all FDA-issued recalls for drugs and biological products issued from 20 June 2012 to 31 December 2014, compounding was associated more frequently with contamination than licensed drugs [ 51 ]. In both France and the UK, compounded CsA formulations are available in glass multi-dose bottles of 10 mL.…”

Section: Discussionmentioning

confidence: 99%

A comparative review of Haute Autorité de Santé and National Institute for Health and Care Excellence health technology assessments of Ikervis® to treat severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes

Eroglu

2017

Journal of Market Access & Health Policy

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Background: In 2015, Ikervis® became the only EMA-approved cyclosporine A (CsA) eye-drop for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes. Since the 1980s, CsA has been used empirically for ocular conditions in veterinary medicine then in humans. However, its extremely low aqueous solubility led to its administration in vegetable oils, which is characterized by low ocular availability, poor intraocular penetration, poor tolerability and short shelf-life. Concentrations from 0.05% to 2% are compounded on an industrial scale and reimbursed throughout Europe. In France, Ikervis® has been granted an ASMR score of 5 by HAS, whereas in UK NICE endorsed its use. Objective: To review the dry eye disease environment, its challenges and available treatment options, and compare the NICE and HAS assessments to question HAS’ decision to maintain full reimbursement of compounded CsA formulations in the absence of evidence, while reimbursing the EMA-approved drug at 15%. Method: extensive search on PubMED. Results: Comparator selection, composite score assessment and use of CE model are key differentiators. Conclusion: In topical formulations, improvements to the vehicle are key innovations that can bring significant benefits. After the USA, a Compounding Act is needed in Europe.

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Characteristics of FDA drug recalls: A 30-month analysis

Abstract: An investigation of FDA drug recalls revealed that the five most common recall reasons were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. Compounding firms were associated more frequently with contamination than were noncompounding firms.

Cited by 42 publications

References 4 publications

Medicine recalls in Saudi Arabia: a retrospective review of drug alerts (January 2010–January 2019)

Medicine recalls in Saudi Arabia: a retrospective review of drug alerts (January 2010–January 2019)

Impact of angiotensin receptor blocker product recalls on antihypertensive prescribing in Germany

A comparative review of Haute Autorité de Santé and National Institute for Health and Care Excellence health technology assessments of Ikervis® to treat severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes

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