-
The Veterinary Record Oct 2019
Topics: Animals; Cat Diseases; Cats; Drug Recalls; Eczema; Veterinary Drugs
PubMed: 31604873
DOI: 10.1136/vr.l5892 -
JAMA Dec 2022
Topics: Drug Approval; Product Surveillance, Postmarketing; United States; United States Food and Drug Administration; Drug Recalls
PubMed: 36480185
DOI: 10.1001/jama.2022.22566 -
The Veterinary Record Mar 2017
Topics: Animal Feed; Animals; Cat Diseases; Cats; Product Recalls and Withdrawals; Thiamine; Thiamine Deficiency; United Kingdom
PubMed: 28283638
DOI: 10.1136/vr.j1202 -
The Veterinary Record Aug 2017
Topics: Animals; Anti-Bacterial Agents; Cats; Dogs; Drug Combinations; Drug Recalls; Sulfadiazine; Trimethoprim; United Kingdom
PubMed: 28821703
DOI: 10.1136/vr.j3914 -
Cardiology in Review 2020Nitrosamines are known carcinogens which have been recently discovered in several angiotensin receptor blockers (ARBs). This led to the recall of valsartan in the United...
Nitrosamines are known carcinogens which have been recently discovered in several angiotensin receptor blockers (ARBs). This led to the recall of valsartan in the United States in 2018, and afterward, the recall of other ARBs as well as unrelated medications (e.g., ranitidine). The presence of nitrosamine in ARBs was likely a result of changes in the manufacturing process, although nitrosamine contamination is believed to occur by different mechanisms with other medications. The United States Food and Drug Administration has since taken steps to identify products affected by nitrosamine contamination and mitigate this concern going forward. Despite the contamination of some drug products, studies estimate that the overall risk to patients is low enough to not necessitate changes in prescribing patterns at this time.
Topics: Angiotensin Receptor Antagonists; Antacids; Carcinogens; Drug Compounding; Drug Contamination; Drug Recalls; Humans; Nitrosamines; Pharmacovigilance; Ranitidine; Safety-Based Drug Withdrawals; United States; United States Food and Drug Administration
PubMed: 32467427
DOI: 10.1097/CRD.0000000000000323 -
The Journal of Bone and Joint Surgery.... Mar 2016The U.S. Food and Drug Administration (FDA) evaluates medical devices by two main pathways. The more stringent Premarket Approval (PMA) review requires clinical trials,... (Review)
Review
BACKGROUND
The U.S. Food and Drug Administration (FDA) evaluates medical devices by two main pathways. The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be substantially equivalent to existing devices. We hypothesized that orthopaedic devices are more likely to be cleared through the 510(k) process and thus are more susceptible to being recalled.
METHODS
Using the FDA's public database, we searched for the following: PMA and 510(k) clearances for orthopaedics and non-orthopaedic specialties, including General & Plastic Surgery, Gastroenterology/Urology, Obstetrics/Gynecology, and Ear Nose & Throat, from 1992 to 2012. Additionally, we searched for all device recall events from 2002 to 2012. For the top-twenty recall companies, we calculated the odds ratio that compares the likelihood of recall for 510(k)-approved devices with that for PMA-approved devices.
RESULTS
From 1992 to 2012, the proportion of non-orthopaedic devices cleared via the 510(k) process decreased from 91% to 53%. However, that of orthopaedic devices decreased only from 94% to 88%. Furthermore, we found that from 2002 to 2012, the percentage of recalled devices was 17.8% for 510(k)-cleared devices and 1.6% for PMA-approved devices. When stratified on the basis of recall class, the odds ratios were 3.5 for class-I devices, 13.2 for class-II devices, and 8.5 for class-III devices.
CONCLUSIONS
Given that 510(k)-cleared devices were 11.5 times more likely to be recalled than PMA-approved devices, it is concerning that most orthopaedic devices are cleared through the 510(k) process with limited clinical trials data.
CLINICAL RELEVANCE
When orthopaedic surgeons are considering using a new device clinically in their patients, it is important for them to consider how the new device was approved by the FDA. If the device was approved by the 510(k) pathway, then it may have been approved without additional clinical studies confirming efficacy or safety.
Topics: Device Approval; Equipment Design; Humans; Medical Device Recalls; Orthopedic Equipment; Orthopedic Procedures; Product Surveillance, Postmarketing; United States; United States Food and Drug Administration
PubMed: 26984921
DOI: 10.2106/JBJS.15.00286 -
The Canadian Journal of Cardiology Oct 2018
Topics: Angiotensin II Type 1 Receptor Blockers; Drug Contamination; Drug Recalls; Drugs, Generic; Humans; Nitrosamines; Valsartan
PubMed: 30269837
DOI: 10.1016/j.cjca.2018.08.011 -
Drug Discovery Today Apr 2016Compared with chemically synthesized small-molecule drugs, the manufacturing process of biopharmaceuticals is more complex. Unexpected changes to product characteristics...
Compared with chemically synthesized small-molecule drugs, the manufacturing process of biopharmaceuticals is more complex. Unexpected changes to product characteristics following manufacturing changes have given rise to calls for robust systems to monitor the postauthorization safety of biopharmaceuticals. We compared quality-related product recalls in the USA of biopharmaceuticals and of small molecules. Although the reasons for recalls for biopharmaceuticals differed from those for small molecules, adverse events were rarely reported. The relative contribution of recalls that could cause serious adverse health consequences was not greater for biopharmaceuticals than for small molecules. Therefore, these data do not give rise to concerns that biopharmaceuticals are more frequently associated with unexpected safety concerns.
Topics: Biological Products; Drug Recalls; Pharmaceutical Preparations; Quality Control; United States
PubMed: 26552336
DOI: 10.1016/j.drudis.2015.10.020 -
Journal of Gynecology Obstetrics and... Oct 2019
Topics: Female; Humans; Medical Device Recalls; Pelvic Organ Prolapse; Surgical Mesh; United States; United States Food and Drug Administration
PubMed: 31283999
DOI: 10.1016/j.jogoh.2019.07.009 -
Nursing Apr 2016
Review
Topics: Databases, Factual; Diffusion of Innovation; Humans; Infusion Pumps; Infusions, Intravenous; Leadership; Nurse's Role; Safety-Based Medical Device Withdrawals; United States; United States Food and Drug Administration
PubMed: 27008058
DOI: 10.1097/01.NURSE.0000480617.62296.d7