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Nature Reviews. Endocrinology Dec 2011Over the past decade, investigators have actively searched for safer therapeutic approaches to replace or complement the use of bisphosphonates and/or parathyroid... (Review)
Review
Over the past decade, investigators have actively searched for safer therapeutic approaches to replace or complement the use of bisphosphonates and/or parathyroid hormone, exploring both antiresorptive and osteoanabolic pathways. Besides marked progress in basic research, the year 2011 has seen several compounds for the treatment of osteoporosis enter or progress within clinical trials.
Topics: Bone Density Conservation Agents; Diphosphonates; Endocrinology; Humans; Osteoporosis; Parathyroid Hormone; Safety-Based Drug Withdrawals; Time Factors
PubMed: 22143180
DOI: 10.1038/nrendo.2011.207 -
Blood Advances Apr 2020Defective blood products that are recalled because of safety or potency deviations can trigger adverse health events and constrict the nation's blood supply chain....
Defective blood products that are recalled because of safety or potency deviations can trigger adverse health events and constrict the nation's blood supply chain. However, the underlying characteristics and impact of blood product recalls are not fully understood. In this study, we identified 4700 recall events, 7 reasons for recall, and 144 346 units affected by recalls. Using geospatial mapping of the newly defined county-level recall event density, we discovered hot spots with high prevalence and likelihood of blood product recall events. Distribution patterns and distribution distances of recalled blood products vary significantly between product types. Blood plasma is the most recalled product (87 980 units), and leukocyte-reduced products (34 230 units) are recalled in larger numbers than non-leukocyte-reduced products (8076 units). Donor-related reasons (92 382 units) and sterility deviations (22 408 units) are the major cause of blood product recalls. Monetary loss resulting from blood product recalls is estimated to be $17.9 million, and economic sensitivity tests show that donor-related reasons and sterility deviations contribute most to the overall monetary burden. A total of 2.8 million days was required to resolve recall events, and probabilistic survival time analysis shows that sterility deviations and contamination took longer to resolve because of their systemic effect on blood collection and processing. Our studies demonstrate that better donor screening procedures, rigorous sterility requirements, improved containment methods, and mitigation of recall events in high-prevalence regions will enable a more robust blood supply chain.
Topics: Cross-Sectional Studies; Prevalence; Product Recalls and Withdrawals; United States; United States Food and Drug Administration
PubMed: 32343797
DOI: 10.1182/bloodadvances.2019001024 -
International Journal of Environmental... Mar 2018This paper addresses the public health issue of toy product recalls in the United States, an under-addressed topic in scholarly literature, yet highly relevant to the...
This paper addresses the public health issue of toy product recalls in the United States, an under-addressed topic in scholarly literature, yet highly relevant to the prevention of pediatric injuries. Toy-related injuries led to 274,000 emergency room visits and seven fatalities in 2016 in the United States, and toy-related injury rates have remained stable over the last five years despite declining incidences of recalls. While dangerous toys not being recalled and the misuse of "safe" products are possible contributing factors, consumer non-response to recall notices also contributes to unintentional child injury from dangerous toys. We discuss the process of recalling toys, and the role of the U.S. Consumer Product Safety Commission in that process. We also review potential factors behind significant consumer non-response to recall notifications, citing economic and psychological theories as explanations for the actions of multiple stakeholders in the recall process. We close by proposing reforms at the regulatory, consumer, and retailer levels that might boost compliance with recall notifications and ultimately reduce injury morbidity and mortality.
Topics: Consumer Behavior; Humans; Incidence; Play and Playthings; Product Recalls and Withdrawals; Public Health; United States
PubMed: 29562602
DOI: 10.3390/ijerph15030540 -
ASAIO Journal (American Society For... Jul 2020Left ventricular assist devices (LVADs) are being increasingly implanted given the increasing prevalence of patients with advanced heart failure stages. However, they... (Review)
Review
Left ventricular assist devices (LVADs) are being increasingly implanted given the increasing prevalence of patients with advanced heart failure stages. However, they are not exempt from device malfunctions. A PubMed search for the key words (left ventricular assist device malfunction) (ventricular assist system malfunction) was performed. We identified 28 publications in the US Food and Drug Administration (FDA) website database that addressed LVAD malfunction. Twenty-nine FDA recalls were identified regarding LVAD malfunctions: 17 regarding HeartWare ventricular assist device, six for HeartMate II, three for HeartMate 3, and three for total artificial heart. Mechanisms involved in LVAD malfunction include battery malfunction, loose driveline connector, malfunction of the system controller, loose power supply connector ports, malfunction of the driveline splice kit, problems with the percutaneous lead connection, disconnection of the bend relief and outflow graft and outflow graft occlusion among others. Multiple mechanisms could be linked to LVAD malfunction. However, multiple device modifications have been developed over the past decade to avoid recurrent malfunctions. Constant improvements and research in biotechnology are needed to prevent these complications. It remains to be seen if newer generation devices will lead to improved patient outcomes over the long term.
Topics: Female; Heart-Assist Devices; Humans; Male; Middle Aged; Safety-Based Medical Device Withdrawals; United States; United States Food and Drug Administration
PubMed: 32091417
DOI: 10.1097/MAT.0000000000001118 -
Drug Discovery Today Jun 2024To introduce products in the US market, pharmaceutical companies must first obtain FDA clearance. Manufacturers might recall a product if it poses a risk of damage or... (Review)
Review
To introduce products in the US market, pharmaceutical companies must first obtain FDA clearance. Manufacturers might recall a product if it poses a risk of damage or violates FDA regulations. This study investigates the types, causes and consequences of recalls, as well as FDA participation and suitable recall strategies. We relied on the FDA website to gather recall data sets from 2012 to 2023, collecting information on the date of issuance, company and type of violation. The most frequent causes for recalls were sterility issues and inadequate compliance with current good manufacturing practices (cGMP). An examination of sterility recalls revealed two primary causes: a lack of assurance in sterility (accounting for 48% of recalls) and instances of non-sterility (making up 45% of recalls). A thorough examination of cGMP recalls revealed five primary types of violations: process control issues, inadequate storage practices, manufacturing problems, the presence of nitroso-amine impurities and concerns regarding stability. The findings demonstrate that sterility and cGMP compliance are FDA priorities. Pharmaceutical companies must, therefore, enhance quality compliance and create effective quality management systems that oversee the manufacturing process, quality control, personnel training and documentation to avoid these recalls. Companies should establish an internal compliance checklist and be prepared for the rectification process.
Topics: United States; United States Food and Drug Administration; Drug Industry; Drug Recalls; Humans; Retrospective Studies
PubMed: 38670257
DOI: 10.1016/j.drudis.2024.103993 -
MAbs 2012This paper examines the development and termination of nebacumab (Centoxin®), a human IgM monoclonal antibody (mAb) drug frequently cited as one of the notable failures... (Review)
Review
This paper examines the development and termination of nebacumab (Centoxin®), a human IgM monoclonal antibody (mAb) drug frequently cited as one of the notable failures of the early biopharmaceutical industry. The non-approval of Centoxin in the United States in 1992 generated major concerns at the time about the future viability of any mAb therapeutics. For Centocor, the biotechnology company that developed Centoxin, the drug posed formidable challenges in terms of safety, clinical efficacy, patient selection, the overall economic costs of health care, as well as financial backing. Indeed, Centocor's development of the drug brought it to the brink of bankruptcy. This article shows how many of the experiences learned with Centoxin paved the way for the current successes in therapeutic mAb development.
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Biopharmaceutics; Costs and Cost Analysis; Drug Approval; Drug Discovery; Humans; Immunotherapy; Product Recalls and Withdrawals; Sepsis; United States
PubMed: 22531443
DOI: 10.4161/mabs.19909 -
Revue Medicale Suisse Jan 2010Main pharmacovigilance signals and alerts issued in 2009 are reviewed. Efalizumab was withdrawn from the market due to increased risks, including progressive multifocal...
Main pharmacovigilance signals and alerts issued in 2009 are reviewed. Efalizumab was withdrawn from the market due to increased risks, including progressive multifocal leukoencephalopathy (PML) and questionable efficacy. New cases of PML are still being reported with rituximab and natalizumab. Rare cases of pure red cell aplasia have been observed with mycophenate. Gastrointestinal perforation, severe skin rashes and various ocular disorders have been reported during erlotinib use. Severe skin rashes have been related to etravirine. Acute renal failure and pancreatitis can occur with exenatide. A link between sitagliptin and pancreatitis is suspected. Raised concerns of causality between insuline glargine and malignant tumors are not supported by strong evidence. Proton pump inhibitors seem to blunt clopidogrel benefit. Aliskiren can cause angioedema.
Topics: Humans; Safety-Based Drug Withdrawals
PubMed: 20170031
DOI: No ID Found -
Reviving the FDA's Authority to Publicly Explain Why New Drug Applications Are Approved or Rejected.JAMA Internal Medicine Aug 2018
Review
Topics: Access to Information; Civil Rights; Drug Approval; Humans; Product Recalls and Withdrawals; Product Surveillance, Postmarketing; United States; United States Food and Drug Administration
PubMed: 29971404
DOI: 10.1001/jamainternmed.2018.3137 -
The Veterinary Record Oct 2015
Topics: Databases, Factual; Drug Industry; Drug Labeling; Drug Packaging; Drug Recalls; Humans; Pharmacovigilance; United Kingdom; Veterinary Drugs; Veterinary Medicine
PubMed: 26515358
DOI: 10.1136/vr.h5761 -
Journal of the Science of Food and... Aug 2014Efforts have been made for global harmonization of food safety regulations among countries through international organizations such as WTO and WHO/FAO. Global...
Efforts have been made for global harmonization of food safety regulations among countries through international organizations such as WTO and WHO/FAO. Global harmonization of food safety regulations is becoming increasingly important for Korean consumers because more than half of food and agricultural products are imported and consumed. Through recent reorganization of the Korean government, a consolidated national food safety authority-the Ministry of Food and Drug Safety (MFDS)-has been established for more efficient food safety control and better communication with consumers. The Automatic Sales Blocking System (ASBS), which blocks the sales of the recalled food products at the point of sale, has been implemented at over 40,000 retail food stores around the nation using state-of-the art information and communication technology (ICT) for faster recall of adulterated food products, and the e-Food Safety Control System has been developed for more efficient monitoring of national food safety surveillance situations. The National Food Safety Information Service was also established for monitoring and collecting food safety information and incidents worldwide, and shares relevant information with all stakeholders. The new approaches adopted by the Korean Food Safety Authority are expected to enhance public trust with regard to food safety issues and expedite the recall process of adulterated products from the market.
Topics: Commerce; Consumer Product Safety; Food Safety; Food Supply; Humans; International Cooperation; Legislation, Food; Product Recalls and Withdrawals; Republic of Korea
PubMed: 23794245
DOI: 10.1002/jsfa.6278