DIVISION OF GASTROINTESTINAL AND COAGULATION DRUG PRODUCTS - MEDICAL OFFICER’S REVIEW

من ويكيتعمر
اذهب إلى: تصفح، ابحث

تعليق: تقرير مهم مسجل في الFDA ويتحدث عن ما حدث في ألمانيا. والتقرير يقر بأن ما يحدث بالتأكيد أكثر مما يتم الإبلاغ عنه.--احمد شوقي محمدين 21:41، 22 أكتوبر 2016 (ت ع م)

شديد الأهمية[عدل]

Visual Disturbances

Based on a preclinical model that links omeprazole with anterior ischemic optic neuropathy and the accumulation of several cases of severe visual disturbances, including blindness, reported in severely ill patients receiving an intravenous formulation of omeprazole, the Bundesgesundheitsamt (BGA). the drug authority of Germany, decided to suspend the registration of the injectable bolus form of omeprazole. In the US post-marketing reports of blurred vision, eye irritation and other opthamologic events have been received. A full analysis of this subject will be performed by Dr. Sheldon Kress, Medical Officer in the DGCDP.


بيانات التقرير[عدل]

DIVISION OF GASTROINTESTINAL AND COAGULATION DRUG PRODUCTS

NDA:

sponsor:

Date Submitted: January 27,ZOOO

Drug: Omeprazole Magnesium (Prilosec ITM) for OTC use

Pharmacological Category:

Formulation:

Administration:

MEDICAL OFFICER’S REVIEW

21-229

Astra-Zeneca LP

Wayne, PA

PPI inhibitor; inhibitor of gastric acid secretion

20 mg tablets

The sponsor proposes that one over-the-counter oral tablet be administered for the relief of heartburn, acid indigestion and sour stomach or for the prevention of these symptoms brought on by consuming food and beverages or associated with events such as stress, hectic life style, lying down for exercise, once every 24 hours for no more than 10 days in a row, unless directed by a doctor.

Material Reviewed: Application, clinical sections, labeling, summary, safety update report, case report tabulations, case report forms, other pertinent information and literature references

Reviewer: Mark Avigan, M.D., C.M.

تقرير أولي[عدل]

three cases of eye disorders and 1 case of vision abnormality occurred

محدودية التقارير لا تعتبر إلا إشارات وغالباً ما يحدث أكثر مما يتم إبلاغه[عدل]

Although varying from year to year, the numbers of these events year to year have not followed a trend of substantial change. As is the case of the clinical trials discussed above, the most commonly reported adverse events were diahrea, headache, nausea, abdominal pain and rash. In the database there were a total of 287 deaths, 142 of which were coded as an adverse event. The database also contains 108 cases of urticaria, 97 cases of hepatitis, 74 cases of hepatic function abnormality, 72 cases of leukopenia, 74 cases of interestitial nephritis, 67 cases of pancreatitis, 67 cases of vision abnormalities and 65 cases of pancytopenia. Each of these side effects will be discussed below in a section devoted to topics of concern related to the safety profile of omeprazole. It should be emphasized that the absolute numbers of patient counts that have been tabulated cannot be extrapolated to the true incidence in the US of omeprazole users. This limitation flows from the voluntary nature of the reporting system and the absence of a comprehensive system of detecting and reporting side effects in the omeprazole-treated population. Thus, the main value of these reports is that they form a basis to identify “signals” of side-effects that are linked to omeprazole

رابط[عدل]

http://www.fda.gov/ohrms/dockets/ac/02/briefing/3861B1_09_Safety.pdf