Electronic Supplementary Material

For manuscript DRSA-D-14-00005R1

The Weber effect and the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS): Analysis of sixty-two drugs approved from 2006-2010.

Keith B. Hoffman1*, Mo Dimbil1, Colin B. Erdman1, Nicholas P. Tatonetti2, Brian M. Overstreet1

1AdverseEvents, Inc., 2Department of Biomedical Informaticsat Columbia University

*Corresponding Author

Keith B. Hoffman

3663 N. Laughlin Road, Suite 102

Santa Rosa, CA, 95403, USA

Tel: (707) 387-9230

Email:

Table 1: Year-by-Year Results for “Health Care Professional” Reporters for Drugs Approved in 2006

Generic Name / Approval Year Case Count / Approval Year (+1) Case Count / Approval Year (+2) Case Count / Approval Year (+3) Case Count / Approval Year (+4) Case Count
Paliperidone / 3 / 608 / 579 / 499 / 858
Carvedilol (Coreg CR) / 0 / 43 / 29 / 20 / 7
Sitagliptin / 43 / 2,548 / 1,459 / 1,211 / 874
Panitumumab / 43 / 338 / 400 / 352 / 432
Budesonide; Formoterol / 44 / 163 / 414 / 304 / 389
Etonogestrel (Implanon) / 13 / 25 / 34 / 156 / 279
Ranibizumab / 62 / 280 / 303 / 530 / 762
Dasatinib / 48 / 160 / 261 / 257 / 309
Darunavir / 14 / 203 / 155 / 161 / 185
Varenicline / 96 / 2,061 / 3,459 / 1,625 / 7,963
Methylphenidate (Daytrana) / 24 / 57 / 24 / 17 / 14
Drospirenone; Ethinyl Estradiol (Yaz) / 18 / 64 / 315 / 441 / 757
Sunitinib / 763 / 572 / 610 / 1,696 / 2,944

Table 2: Year-by-Year Results for “Health Care Professional” Reporters for Drugs Approved in 2007

Generic Name / Approval Year Case Count / Approval Year (+1) Case Count / Approval Year (+2) Case Count / Approval Year (+3) Case Count / Approval Year (+4) Case Count
Nebivolol / 0 / 51 / 327 / 247 / 95
Methoxy Polyethylene Glycol-Epoetin Beta / 2 / 63 / 153 / 166 / 177
Nilotinib / 41 / 291 / 423 / 463 / 768
Ixabepilone / 14 / 142 / 172 / 171 / 56
Raltegravir / 11 / 287 / 306 / 337 / 225
Amlodipine; Valsartan / 49 / 111 / 109 / 120 / 144
Ambrisentan / 55 / 409 / 673 / 1,077 / 1,951
Armodafinil / 0 / 6 / 39 / 74 / 157
Temsirolimus / 148 / 426 / 310 / 440 / 338
Quetiapine (Seroquel XR) / 4 / 88 / 294 / 631 / 530
Rotigotine / 24 / 88 / 86 / 99 / 121
Fluticasone Furoate / 21 / 41 / 36 / 51 / 53
Zoledronic Acid (Reclast) / 81 / 540 / 1,164 / 1,390 / 1,358
Metformin; Sitagliptin / 25 / 68 / 102 / 145 / 243
Eculizumab / 4 / 5 / 994 / 521 / 562
Lapatinib / 340 / 537 / 677 / 694 / 806
Aliskiren / 350 / 446 / 429 / 778 / 695
Lisdexamfetamine / 116 / 355 / 367 / 146 / 114
Diclofenac (Flector) / 0 / 13 / 50 / 106 / 12

Table 3: Year-by-Year Results for “Health Care Professional” Reporters for Drugs Approved in 2008

Generic Name / Approval Year Case Count / Approval Year (+1) Case Count / Approval Year (+2) Case Count / Approval Year (+3) Case Count / Approval Year (+4) Case Count
Bimatoprost (Latisse) / 0 / 173 / 521 / 285 / 172
Choline Fenofibrate / 1 / 682 / 476 / 99 / 36
Eltrombopag / 3 / 141 / 386 / 486 / 233
Fesoterodine / 7 / 68 / 528 / 212 / 220
Lacosamide / 1 / 198 / 359 / 555 / 419
Romiplostim / 66 / 516 / 2,207 / 2,146 / 754
Tetrabenazine / 2 / 120 / 367 / 226 / 282
Certolizumab / 12 / 1,692 / 2,683 / 2,043 / 1,340
Bendamustine / 70 / 168 / 250 / 627 / 1,247
Desvenlafaxine / 554 / 265 / 2,381 / 608 / 577
Niacin; Simvastatin / 113 / 140 / 88 / 21 / 25

Table 4: Year-by-Year Results for “Health Care Professional” Reporters for Drugs Approved in 2009

Generic Name / Approval Year Case Count / Approval Year (+1) Case Count / Approval Year (+2) Case Count / Approval Year (+3) Case Count / Approval Year (+4) Case Count
Pazopanib / 35 / 249 / 450 / 435 / No FAERS Data
Ustekinumab / 55 / 399 / 806 / 1,079 / No FAERS Data
Interferon Beta-1B (Extavia) / 12 / 81 / 141 / 172 / No FAERS Data
Asenapine / 21 / 1,560 / 907 / 581 / No FAERS Data
Saxagliptin / 34 / 587 / 295 / 178 / No FAERS Data
Treprostinil (Tyvaso) / 3 / 98 / 412 / 264 / No FAERS Data
Prasugrel / 52 / 559 / 415 / 335 / No FAERS Data
Dronedarone / 183 / 871 / 1,081 / 275 / No FAERS Data
Golimumab / 185 / 461 / 765 / 894 / No FAERS Data
Everolimus (Afinitor) / 153 / 858 / 1,147 / 1,312 / No FAERS Data
Milnacipran / 278 / 461 / 258 / 82 / No FAERS Data

Table 5: Year-by-Year Results for “Health Care Professional” Reporters for Drugs Approved in 2010

Generic Name / Approval Y Case Count / Approval Y (+1) Case Count / Approval Y (+2) Case Count / Approval Y (+3) Case Count / Approval Y (+4) Case Count
Denosumab (Xgeva) / 0 / 280 / 657 / No FAERS Data / No FAERS Data
Dabigatran / 288 / 6,363 / 6,871 / No FAERS Data / No FAERS Data
Fingolimod / 50 / 1,555 / 2,082 / No FAERS Data / No FAERS Data
Denosumab (Prolia) / 167 / 1,129 / 2,350 / No FAERS Data / No FAERS Data
Everolimus (Zortress) / 392 / 269 / 217 / No FAERS Data / No FAERS Data
Liraglutide / 1,200 / 2,245 / 975 / No FAERS Data / No FAERS Data
Dalfampridine / 173 / 227 / 294 / No FAERS Data / No FAERS Data
Tocilizumab / 1,032 / 1,038 / 1,420 / No FAERS Data / No FAERS Data

Table 6:

Generic Name / estimate.intercept / lci.estimate.intercept / uci.estimate.intercept / pval.estimate.intercept / estimate.period / lci.estimate.period / uci.estimate.period / pval.estimate.period
Bimatoprost (Latisse) / 112.8742 / -12.9133 / 238.6618 / 0.071523 / -5.71767 / -15.9654 / 4.530096 / 0.228575
Choline Fenofibrate / 34.70689 / 2.109232 / 67.30455 / 0.039949 / -1.8165 / -4.47219 / 0.839193 / 0.149823
Eltrombopag / 173.1431 / 106.9106 / 239.3757 / 0.000453 / -8.54017 / -13.9361 / -3.14428 / 0.007239
Fesoterodine / 41.44756 / 2.75692 / 80.13819 / 0.039055 / -0.32433 / -3.47641 / 2.827747 / 0.814743
Lacosamide / 125.1133 / 45.99491 / 204.2318 / 0.00727 / -4.74083 / -11.1865 / 1.704851 / 0.125556
Romiplostim / 168.4196 / 126.9259 / 209.9132 / 0.000028 / -9.04117 / -12.4216 / -5.66073 / 0.000395
Tetrabenazine / 34.45644 / -12.7928 / 81.70565 / 0.128292 / 1.488167 / -2.36117 / 5.337503 / 0.391028
Certolizumab / 156.2758 / 59.53555 / 253.016 / 0.006544 / -8.099 / -15.9803 / -0.21769 / 0.045425
Bendamustine / -18.7276 / -82.5834 / 45.12832 / 0.510349 / 7.052667 / 1.850404 / 12.25493 / 0.014947
Desvenlafaxine / 56.77044 / -59.871 / 173.4118 / 0.287571 / -3.07967 / -12.5823 / 6.42297 / 0.468524
Niacin; Simvastatin / 57.19089 / -54.3322 / 168.7139 / 0.264607 / -1.87683 / -10.9625 / 7.208818 / 0.640151
Nebivolol / 119.5849 / -7.56672 / 246.7365 / 0.061522 / -6.80133 / -17.1602 / 3.557558 / 0.164475
Methoxy Polyethylene Glycol-Epoetin Beta / 34.43422 / -6.7311 / 75.59954 / 0.088445 / 3.960667 / 0.606977 / 7.314357 / 0.026808
Nilotinib / -38.5116 / -81.485 / 4.46192 / 0.071816 / 8.028 / 4.527002 / 11.529 / 0.000985
Ixabepilone / 82.96311 / 25.04228 / 140.8839 / 0.011647 / -3.78017 / -8.49891 / 0.938575 / 0.100042
Raltegravir / 119.4567 / 66.45003 / 172.4633 / 0.001089 / -3.85 / -8.16839 / 0.468388 / 0.072988
Amlodipine; Valsartan / 13.70422 / -27.3111 / 54.71955 / 0.455409 / 4.300667 / 0.959197 / 7.642137 / 0.018757
Ambrisentan / -58.8396 / -94.1475 / -23.5317 / 0.005599 / 9.520333 / 6.64384 / 12.39683 / 0.000105
Armodafinil / -66.5156 / -137.734 / 4.702902 / 0.062939 / 8.9675 / 3.165417 / 14.76958 / 0.008127
Temsirolimus / 43.74533 / -26.8904 / 114.381 / 0.18649 / 1.023167 / -4.73144 / 6.777774 / 0.686778
Quetiapine (Seroquel XR) / 23.68644 / -89.001 / 136.3739 / 0.634393 / 0.404833 / -8.77568 / 9.585347 / 0.919878
Rotigotine / 12.94444 / -35.0169 / 60.90575 / 0.543651 / 4.916667 / 1.009316 / 8.824017 / 0.020648
Fluticasone Furoate / 33.13933 / -60.0539 / 126.3326 / 0.428214 / 0.387833 / -7.20451 / 7.980177 / 0.907251
Zoledronic Acid (Reclast) / -4.81956 / -30.8111 / 21.17203 / 0.674261 / 6.722833 / 4.60533 / 8.840337 / 0.000136
Metformin; Sitagliptin / 0.144 / -50.9057 / 51.19369 / 0.994864 / 5.944667 / 1.785709 / 10.10362 / 0.01176
Eculizumab / 89.70822 / -17.2877 / 196.7042 / 0.087849 / -4.668 / -13.3848 / 4.048833 / 0.245917
Lapatinib / 50.07644 / -7.22208 / 107.375 / 0.077608 / 1.254833 / -3.41321 / 5.922876 / 0.545221
Aliskiren / -2.02778 / -35.2617 / 31.20615 / 0.889347 / 4.385833 / 1.678305 / 7.093362 / 0.006455
Lisdexamfetamine / 60.40689 / -23.9634 / 144.7772 / 0.134287 / -3.3165 / -10.19 / 3.557049 / 0.291422
Diclofenac (Flector) / -27.308 / -133.382 / 78.76649 / 0.561915 / 4.418167 / -4.2236 / 13.05993 / 0.265934
Paliperidone / 15.91622 / -37.8136 / 69.64604 / 0.506244 / 4.458 / 0.080695 / 8.835305 / 0.046897
Carvedilol (Coreg CR) / 67.30889 / 46.03363 / 88.58414 / 0.00014 / -3.74083 / -5.4741 / -2.00756 / 0.001394
Sitagliptin / 95.06067 / 50.5036 / 139.6177 / 0.001488 / -4.61283 / -8.24285 / -0.98282 / 0.019806
Panitumumab / 108.2424 / 40.26865 / 176.2162 / 0.007025 / -2.61483 / -8.15258 / 2.922912 / 0.301047
Budesonide; Formoterol / 83.86956 / -30.7534 / 198.4925 / 0.127214 / -1.872 / -11.2102 / 7.466193 / 0.649908
Etonogestrel (Implanon) / -54.2471 / -122.066 / 13.57178 / 0.100465 / 8.954667 / 3.429542 / 14.47979 / 0.006438
Ranibizumab / -41.8369 / -75.8001 / -7.87368 / 0.02257 / 8.029 / 5.262058 / 10.79594 / 0.000239
Dasatinib / 93.39467 / 23.12958 / 163.6598 / 0.016311 / -2.12233 / -7.84675 / 3.60208 / 0.409732
Darunavir / 62.26378 / 28.92924 / 95.59832 / 0.003093 / -0.80717 / -3.52289 / 1.908559 / 0.504867
Varenicline / 125.2631 / 80.02998 / 170.4962 / 0.000319 / -6.35517 / -10.0403 / -2.67008 / 0.004702
Methylphenidate (Daytrana) / 42.28089 / 0.185672 / 84.37611 / 0.049239 / -1.171 / -4.60045 / 2.258448 / 0.445994
Drospirenone; Ethinyl Estradiol (Yaz) / 29.17 / -45.3775 / 103.7175 / 0.385616 / 3.0525 / -3.0208 / 9.1258 / 0.273395
Sunitinib / 1.341556 / -24.9471 / 27.63026 / 0.907343 / 5.766167 / 3.624457 / 7.907876 / 0.000379