There are some compounding pharmacies that prepare compounded pain creams and ointments that contain a combination of potent medications.

Many include drugs that can cause central nervous system depression or cardiac effects such as  ketamine, gabapentin, clonidine, tricyclic antidepressants and baclofen.  Most of these drugs have not been US Food and Drug Administration (FDA)-approved for topical use (though off-label use of medications is routine).

Because their use is growing, some pharmacies have employed a sales force, and have provided template prescriptions to make prescribing of these creams easier. Some prospective patients have received unsolicited calls at home, promising that the cream can be prescribed after an arranged phone consultation with a physician.

The Philadelphia Poison Control Center has had 8 cases reported due to these products within the last 12 months. There have been cases of children ingesting or applying the creams, of adults having adverse effects with appropriate use, and of adults intentionally abusing it.

In a case reported last year, severe toxicity occurred in an 18-month-old child when his father’s compounded ointment was used to treat a diaper rash. A 47 year old woman experienced a low heart rate, slurred speech and dizziness after applying her compounded pain cream containing 5 ingredients, including clonidine, a blood pressure medication.

These products, which are not packaged in containers with a safety closure, might also not be as carefully stored as other medications in order to avoid accidental child exposures.

Jeanette Trella, the Managing director of the Poison Control Center at the Children’s Hospital of Philadelphia says, “Because safety issues can arise with any compounded, unapproved formulations of medications, regulatory or licensing oversight is necessary. With compounded pain creams and ointments, we are specifically concerned about some compounding company statements that may be unproven, such as the products’ safe use with children.    10/3/14


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