[15703140]
Overdose [overdose]. Case description: this case, (b)(4), is a solicited report from the united states referring to an (b)(6) male patient. A consumer reported the event from a genentech sponsored patient support program for somatropin. No past medical history, concurrent illnesses, allergies or concomitant medications were reported. On a date not reported, the patient received somatropin (2. 8 mg, qd, subcutaneous) using a somatropin pen for an unspecified indication. The lot number was not reported. The last dose administered prior to the onset of the event was not reported. The first puncture date of the product in question and the patient's history of exposure to the product lot number in question were not reported. On (b)(6) 2009, the patient experienced an overdose (overdose). Relevant laboratory tests and treatments for the event were not reported. On (b)(6) 2009, the patient "just figured out why his medication supply was running out early". The patient noted that he had been using the somatropin aq 20 mg cartridges in the 10 mg aq pen. The patient stated that he "just realized this" and switched to the appropriate 20 mg pen. It was not reported if the patient continued use with the product lot number in question and if the patient switched to another lot number. It was further noted that he thought this had occurred over the past 5 months. The patient made no comment regarding any side effects of this error but was advised to call his physician. Action taken with somatropin was not reported. The patient discontinued use with somatropin 10 mg pen. At the time of this report, the event outcome was not reported. The event was identified as medically significant by the reporter. The consumer did not provide an assessment for the event of overdose in relation to somatropin and somatropin pen. No other possible etiological factors were reported. This report was forwarded to genentech product support and assigned (b)(4). Additional information is being requested. If received, the case will be updated accordingly. Pharmacovigilance: overdose is labeled in the (b)(4) for somatropin for an unspecified indication. Based on the temporal relationship between the onset of the event and administration of somatropin, a causal association cannot be excluded. The patient did not realize that he was using a 20 mg cartridge in a 10 mg pen.
Patient Sequence No: 1, Text Type: D, B5