[55995954]
This spontaneous report was received from (b)(6) (b)(4) on (b)(6) 2016. Additional information received on 07-sep-2016 was combined with the initial. A consumer reported that on an unknown date in "2004 or 2006," after the female patient started the breathtek ubt kit (breathtek ubt kit), (unknown dose by mouth, one time dose), for helicobacter pylori urea breath test, she immediately experienced a "severe allergic reaction,"which required her to go to the emergency room. While she was in the emergency room she was given an "adrenaline shot;" after a few hours this "severe allergic reaction" resolved. This spontaneous report was received from (b)(6) (b)(4) on (b)(6) 2016. Additional information received on 07-sep-2016 was combined with the initial. The patient's medical history included irritable bowel syndrome, gluten sensitivity, allergy to cow's milk, allergy to grains, allergy to peanuts and tree nuts, allergy to whey protein allergy, and other products. She was on "other unknown concomitant medications. " diagnostic tests revealed the following results: unspecified test administered to determine lactose intolerance. She did not finish the breathtek test as she had the allergic reaction prior to the final sample collection. The consumer could not say for certain if the test had definitely caused her allergic reaction. Her physician wants to administer a breathtek ubt kit in the near future. The outcome of severe allergic reaction was recovered/resolved. The consumer could not say for certain the previous testing had definitively caused her allergic reaction. Otsuka causality assessment: the reported event allergic reaction is considered as related to breathtek ubt kit, given the temporal association and positive dechallenge, however the patient also had significant history of gluten sensitivity, allergy to cow's milk, allergy to grains, allergy to peanuts and tree nuts, allergy to whey protein allergy, and other products, which could have also contributed to the reported event. The information provided by the reporter is also not clear, as it was reported the event happened in 2004 or 2006 and the consumer could not say for certain if the previous testing caused allergic reaction, which precludes a meaningful medical assessment. Otsuka does not consider the information contained in this individual case safety report to justify any change to the benefit-risk balance of breathtek ubt kit or to justify any safety measures.
Patient Sequence No: 1, Text Type: D, B5