Alleged isotretinoin-associated inflammatory bowel disease: Disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System

Melanoma and non-Melanoma Skin Cancer in Inflammatory Bowel Disease Patients following Tumor Necrosis Factor-α Inhibitor Monotherapy and in Combination with Thiopurines: Analysis of the Food and Drug Administration Adverse Event Reporting System

“…e second largest number of skin cancer reports was associated with individuals managing their IBD through dual therapy of a TNF-α inhibitor and a thiopurine (Table II). As our group has previously described a potential bias in the FAERS related to lawyer reports, it is important to note that only one control reaction was reported by a lawyer and none of the MSC or NMSC cases were reported by lawyers [18].…”

Maternal and foetal adverse events with tumour necrosis factor-alpha inhibitors in inflammatory bowel disease

“…The patient characteristics were similar across drug exposure groups with majority of the cases reported by physicians and other healthcare professionals. Only 0.3% of all reports with study drugs (three cases) were reported by attorneys (compared to 3.6% usually reported across various medications in the FAERS) …”

“…Only 0.3% of all reports with study drugs (three cases) were reported by attorneys (compared to 3.6% usually reported across various medications in the FA-ERS). 22 Details of the various maternal/foetal AEs (959 reports) are shown in Table 2. Abortions (323 reports) were the most common AEs and were mainly reported among patients receiving TNF-a inhibitor alone (237 reports, 73.4%).…”

Reporting trends of adverse effects from proton pump inhibitors to the food and drug administration

“…This type of reporting interference has previously influenced the perception on the occurence of rare drug adverse events. In 2013, our group reported that lawyers were responsible for 87.8% of cases of the AE of inflammatory bowel disease (IBD) associated with isotretinoin reported to FAERS, whereas physicians only reported 6.0% of these cases 13 . A signal inflation factor of 5.82 was calculated for attorney‐initiated reports of IBD from isotretinoin to FAERS using a method proposed by Schulterman and Smith 14 .…”