Monitoring Medication Safety: The Saudi Food and Drug Authority (SFDA) received over 173,000 reports of drug side effects in the first half of 2024, emphasizing that these side effects are expected and listed in medication inserts, allowing for the safe monitoring and management of medication use.
Common Drugs and Side Effects: The most frequently reported drugs for side effects were Amlodipine, Atorvastatin, Furosemide, Metformin, and Esomeprazole, with common side effects including headaches and constipation (5.65%), nausea (4.54%), dizziness (3.8%), and abdominal pain (3.24%).
Encouraging Public Reporting: The SFDA encourages the public to report any adverse effects or misuse of medications and cosmetic products through its unified call center or the Saudi Vigilance System to enhance drug safety and public health.
On September 3, 2024, the Saudi Food and Drug Authority (SFDA) reiterated its commitment to ensuring the safe use of medications and enhancing its communication with the public to address health-related concerns. As part of these ongoing efforts, the SFDA reported receiving more than 173,000 notifications of drug side effects during the first half of 2024. These reports were submitted through official channels from all regions across the Kingdom, reflecting a broad engagement from various segments of Saudi society.
The SFDA emphasized that the reported side effects are generally anticipated and are commonly noted in the medication package inserts. Such side effects do not typically pose a significant risk to patients or affect the recommended use of the medications. By collecting and analyzing these reports, the SFDA is able to closely monitor the prevalence of various drugs within the population, ensuring that any potential issues related to their use are promptly addressed and managed. This proactive approach allows for the implementation of targeted measures to mitigate risks and improve patient safety.
Among the drugs most frequently associated with side effects during this period were Amlodipine, Atorvastatin, Furosemide, Metformin, and Esomeprazole. These medications are widely used for treating conditions such as hypertension, high cholesterol, heart failure, type 2 diabetes, and acid reflux, respectively. The SFDA highlighted that the most commonly reported side effects for these medications included headaches and constipation, each occurring at a rate of 5.65%. Other frequently noted symptoms were nausea, reported at a rate of 4.54%, dizziness at 3.8%, and abdominal pain at 3.24%.
These statistics underscore the importance of ongoing vigilance in monitoring the effects of widely prescribed medications. The SFDA remains dedicated to fostering an environment where healthcare providers and patients can confidently report adverse effects, contributing to a comprehensive understanding of medication safety. This is vital not only for protecting individual patients but also for enhancing public health outcomes on a national scale.
The SFDA continues to urge all citizens to report any adverse reactions or cases of misuse involving cosmetic or pharmaceutical products. Such reports can be made through the SFDA's unified call center at 19999 or via the Saudi Vigilance System, accessible at https://ade.sfda.gov.sa/. By maintaining an open line of communication with the public, the SFDA seeks to empower individuals with the information and support needed to ensure the safe and effective use of all medications across the Kingdom.
The agency's commitment to transparency and safety reflects its broader mission to uphold the highest standards of public health in Saudi Arabia, fostering a well-informed community that actively participates in the ongoing efforts to safeguard health and well-being.