However, several news, e-messages and videos that have recently widely spread and communicated through the media and the social media have pointed out that taking these drugs may cause side effects such as chronic kidney diseases, dementia, heart diseases, Osteoporosis, and low magnesium levels. SFDA has prepared a drug safety file for this drug upon reviewing the published studies and researches in this field and searching SFDA’s and other International authorities databases relevant to side effects, e.g. WHO, and also through assessment of the approved leaflets related to drug products which all concluded that no increase in such side effects coinciding with the use of these drugs. Moreover, such side effects are described in the drug pamphlet or inserts.

SFDA would like to stress that the reported side effects worldwide are very few compared to the popular use of these drugs. There may be other interpretation for the occurrence of these side effects other than using these drugs, e.g. contradiction with other drugs or different genetics. It should be noted that drug regulations in the Kingdom require that such drugs should be dispensed according to doctor’s prescription and shall be used according to the directions of the physician and the pharmacist and as described in the drug leaflet.

International drug authorities, such as the European Agency as well as SFDA, are now reviewing the safety and security of these drugs, given that US FDA or EU Agency did not take any precautionary procedures or plans to minimize the risk of these products. SFDA is now assessing the side effects relevant to kidney diseases in order to determine the relation between using these drugs and the kidney diseases. The assessment will be completed very soon and its results will be published.

SFDA continuously monitors the safety of drugs in the Saudi market through establishing several channels for receiving reports and communication of national and international warnings and alerts.

SFDA advises all community members to report any drug side effects to the National Pharmacovigilence Center by completion of the appropriate electronic forms through the link: https://ade.sfda.gov.sa or send an e-mail message to: npc.drug@sfda.gov.sa, or call the Free Phone number: 8002490000 or Universal number: 19999

 Exhibit 1:

List of Proton Pumps Inhibitors Drugs registered in KSA and released by SFDA.

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