[17439448]
The case was reported by a consumer's spouse who reported that the patient with a four year medical history of hypertension, experienced three separate, but similar events of low blood potassium while using super wernet's (denture adhesive powder) for loose dentures. The consumer's spouse contacted the manufacturer to inquire if there was a known relationship between super wernet's and blood potassium. A physician or other health care professional has not verified this report. In january 2003 (date unspecified) the consumer started using super wernet's (dental) and currently continues with its use. On three separate occasions beginning february 2003, then in "mid year" 2003 and also in january 2004, the consumer experienced similar incidences of severe tremors and chills. The consumer went to the emergency room on each of the days that consumer experienced these symptoms. The medical testing and treatment at these visits were similar. The consumer's spouse reported that the consumer had no history of these symptoms prior to february 2003. The consumer's spouse reported that the consumer was diagnosed with low blood potassium that ranged from 2. 0-2. 2 on all three emergency room visits and was treated similarly. Spouse reported that unspecified blood work was taken on all visits. The consumer's spouse was unable to report the results of other blood testing,or the consumer's normal blood potassium. The consumer was treated with i. V potassium in each emergency room visit and advised to take klor-com (20 meq,oral,daily) for potassium supplementation after the first episode, as well as after subsequent visits. The consumer's spouse was unable to report the consumer's final blood potassium level. The consumer was never admitted to the hospital. The emergency room physicians were not told of the consumer's use of super wernet's. The consumer's spouse was not made aware by the patient's physicians of the cause for the consumer's low potassium level, tremor or chills. The consumer's symptoms improved after each emergency room visit, but shortly after each visit (time unspecified) the consumer would experience mild chills and shaking intermittently. The consumer's spouse additionally reported that they have seen three additional physicians throughout the year to help diagnose these symptoms and no diagnosis for these symptoms has been given. The use of super wernet's was not discussed with these physicians. Throughout the year the consumer has had an eeg, brain scan, stress test and three unspecified thyroid function tests symptoms, the results of which were normal. The consumer's spouse reported that the consumer has continued to have occasional bouts of mild tremors and chills from february 2003 to the present despite close monitoring of their potassium level and their use of potassium supplement. At the time of this contact, the consumer's symptoms had resolved. The consumer plans on continuing product use and is planning further medical follow-up for these symptoms. The consumer's spouse plans on letting the physician know about the patient's use of super wernets. The consumer's spouse reported no additional medical history and the consumer has no medication allergies. Concurrent medications included hyzaar, baby aspirin and klor-con. The consumer's spouse refused to grant permission for the manufactureer to contact the consumer for the physician follow-up. This case was assessed as medically serious by the glaxosmithkline product safety physician. Super wernet's manufactured by glaxosmithkline has been identified as a suspect product in this case. Super wernets is manufactured in dungavaran, ireland. The lot number for this product is available an a quality evaluation is planned.
Patient Sequence No: 1, Text Type: D, B5