Table 3.
Clinical Characteristics of the 106 Adverse Reactions in Patients Confirmed to Have Received Heparin Contaminated with OSCS and with >20% OSCS.*
| Characteristic | Reaction with OSCS- Contaminated Heparin (N = 106) |
Reaction with Heparin Contaminated with >20% OSCS (N = 18) |
|---|---|---|
| Case status — no. (%) | ||
| Probable | 89 (84.0) | 16 (88.9) |
| Definite | 17 (16.0) | 2 (11.1) |
| Patient population — no. (%) | ||
| Dialysis | 85 (80.2) | 18 (100) |
| Cardiac | 7 (6.6) | 0 |
| Photopheresis† | 14 (13.2) | 0 |
| Time from administration of heparin to reaction — min | ||
| During dialysis | 4.8±9.0 | 3.7±1.7 |
| During treatment for cardiac conditions | 15.9±17.7 | — |
| During photopheresis | 30±13.2 | — |
| Manifestations — no. (%) | ||
| Facial edema | ||
| Any | 17 (16.0) | 2 (11.1) |
| Eyelids | 11 (10.4) | 0 |
| 11 (10.4) | 1 (5.6) | |
| Tongue | 5 (4.7) | 1 (5.6) |
| Mouth | 5 (4.7) | 2 (11.1) |
| Throat | 3 (2.8) | 1 (5.6) |
| Urticaria | 2 (1.9) | 0 |
| Low blood pressure | 62 (58.5) | 10 (55.6) |
| Systolic pressure <80 mm Hg | 10 (9.4) | 0 |
| Nausea | 49 (46.2) | 12 (66.7) |
| Vomiting | 30 (28.3) | 4 (22.2) |
| Shortness of breath | 27 (25.5) | 7 (38.9) |
| Flushing | 27 (25.5) | 4 (22.2) |
| Tachycardia | 26 (24.5) | 0 |
| Tingling | 26 (24.5) | 7 (38.9) |
| Diaphoresis | 17 (16.0) | 5 (27.8) |
| Loss of consciousness | 4 (3.8) | 0 |
| Difficulty swallowing | 0 | 0 |
*
Forty-six reactions are not included: 2 were in patients who did not receive OSCS-contaminated heparin, and 22 were in patients who may have received OSCS-contaminated heparin but for whom receipt could not be confirmed; for the remaining 22 reactions, we did not receive lot information and were thus unable to make a determination. Plus–minus values are means ±SD. OSCS denotes oversulfated chondroitin sulfate.
†
Although heparin is administered at the beginning of photophoresis, the patient is not exposed to it until later in the process.