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Appendix F: Adverse Events Table
Pages 287-304

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From page 287...
... See Chapters 4, 6, and 7 for additional discussions on what is known about the safety of compounded topical pain creams.
From page 288...
... 18m male; application Ketamine 100 mg; clonidine Misuse of father's CPC 2 mg; gabapentin 60 mg; (prescribed for neck mefenamic acid 10 mg; pain) to treat diaper imipramine 30 mg; and rash lidocaine 10 mg 22m female; cream The concomitant medications Misuse was prescribed were ketoprofen, lidocaine, to another family prilocaine, camphor, menthol, member for an ethoxydiglycol, and gabapentin unknown indication, accidental ingestion of CPC 26m male; accidental Ketamine 10%, clonidine 0.2%, Misuse ingestion of his gabapentin 6%, diclofenac 5%, mother's CPC baclofen 2%, cyclobenzaprine 2%, menthol 1%, nifedipine 2%, and bupivacaine 1% 2y female; accidental Pregabalin 2.5% (w/v)
From page 289...
... An EKG after intubation revealed accidental ingestion of sinus bradycardia with a rate of 75 BPM, nonspecific a compounding cream. T-wave inversions, and a first-degree block with a Pediatric Emergency Care PR interval of 178 milliseconds with normal QRS and 34(4)
From page 290...
... 290 COMPOUNDED TOPICAL PAIN CREAMS TABLE F-1 Continued Suspected Cause of Patient Demographics/ Adverse Event (SKRI-1; Condition Drugs Present in Compound C-1-5) 2y male; accidentally Nifedipine 2%, clonidine 0.2%, Misuse smeared his body with 10% ketamine, 5% diclofenac, CPC baclofen 2%, gabapentin 6%, cyclobenzaprine 2%, menthol 1%, and bupivicaine 1% 22y female; over Lidocaine 10% and tetracaine Misuse application of CPC, 10% followed by wrapping area in plastic wrap 23y male; over Clonidine 0.2%, gabapentin Misuse application of a CPC 6%, imipramine 3%, ketamine 10%, lidocaine 2%, mefenamic acid 1% 34y female; intentional Bupivicaine 90 mg, clonidine Misuse ingestion while on 0.9 mg, cyclobenzaprine 90 methadone mg, flurbiprofen 450 mg, and ketamine 450 mg 35y male; prescribed Ketamine 900 mg; baclofen Misuse cream for relief of 900 mg; amitriptyline 360 chronic pain, over mg; lidocaine 900 mg; and application of CPC ketoprofen 1,800 mg 36y male; used expired Neuromax pain cream Misuse CPC on his calf (ketamine 15%, gabapentin 6%, muscles clonidine 0.2%, prilocaine 7%, baclofen 3%, diclofenac 2%)
From page 291...
... Patient had progressive downward course with Unknown seizure, decreasing responsiveness, and gradual loss of brainstem reflexes, variability in BP and HR, and elevated intracranial pressure. CT scan showed evolution of severe profound cerebral edema.
From page 292...
... 29y female; prescribed Pentoxifylline 3%, diclofenac Reaction due to for oral mucosa for 3%, bupivacaine 1%, gabapentin unknown cause (e.g., dental pain 6%, baclofen 2%, ibuprofen 3%, allergy to the API or ketamine 10% excipient; drug–drug interactions; systemic toxicity; suboptimal compounded preparations)
From page 293...
... 2014. Inappropriate revealed a nonanion gap metabolic acidosis, and EEG application of demonstrated nonspecific findings consistent with compounded topical toxic metabolic encephalopathy.
From page 294...
... 37y female; CPC used Benzocaine 20%, lidocaine 6%, Reaction due to to numb area prior to tetracaine 4% unknown cause (e.g., a skin treatment allergy to the API or excipient; drug–drug interactions; systemic toxicity; suboptimal compounded preparations) 37y female; prescribed Compounded cream bupi/ Reaction due to CPC for shoulder pain clon/doxe/gaba/pent (1-K)
From page 295...
... When patient attempted to selfmedicate with aloe vera, further irritation occurred. Within 5 minutes of application patient experienced N/A tachycardia, diaphoresis, and chest pressure; after 15 minutes, abnormal involuntary movements with spasms including neck and jaw.
From page 296...
... 49y female; prescribed Diclofenac 5%, baclofen Reaction due to CPC for chronic pain 2%, cyclobenzaprine 2%, unknown cause (e.g., in ankles, knees, wrists, bupivacaine 1%, lidocaine 5%, allergy to the API or hands, shoulder, and prilocaine 2.5%, imipramine 3% excipient; drug–drug neck interactions; systemic toxicity; suboptimal compounded preparations) 50y female; prescribed Concentrations/ingredients Reaction due to cream for tarsal tunnel are unknown, compound was unknown cause (e.g., syndrome in both feet called Jonas Neuropathy allergy to the API or Cream #3 excipient; drug–drug interactions; systemic toxicity; suboptimal compounded preparations)
From page 297...
... Patient experienced red ulcerating nodules and was N/A very itchy where cream was applied for about 1 week. Full recovery in about 1 month.
From page 298...
... Reaction due to CPC for rectal pain sodium oxybate, baclofen, unknown cause (e.g., (included rectal allergy to the API or tenesmus, burning and excipient; drug–drug nerve pain) interactions; systemic toxicity; suboptimal compounded preparations)
From page 299...
... Patient experienced edema in lower legs and knees, with stasis pigmentation, coldness in her legs, and abnormal sensations in her hands. These symptoms persist to a lesser extent after she stopped using the cream.
From page 300...
... 70y female; prescribed Compounded cream Reaction due to for idiopathic itching, (gabapentin/lidocaine/ unknown cause (e.g., rash, shingles, and clonidine/ketamine topical allergy to the API or neuralgia cream, percentages or mg excipient; drug–drug of each API not given) , interactions; patient was also taking the systemic toxicity; following oral medications: suboptimal neurontin (gabapentin)
From page 301...
... N/A After 6 days the patient noticed his foot skin looked N/A like it had undergone a bad chemical burn but without pain, areas ranged from red to purple with some blistering and peeling. The patient began taking gabapentin (Neurontin)
From page 302...
... For full submitted data please see the Public Access File for the Committee on the Assess­ ent of the Available Scientific Data Regarding the Safety and Effectiveness m of Ingredients Used in Compounded Topical Pain Creams at the National Academies website at https://www8.nationalacademies.org/pa/managerequest.aspx? key=HMDHSP-18-18 (accessed April 9, 2020)
From page 303...
... Delirium following altered mental status was a consequence of dementia, topical application of both risperidone and lorazepam were prescribed. compounded creams Six days later, she applied the cream over her upper containing multiple body, arms, perineum, and vulva.


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