The U.S. Food and Drug Administration (FDA), the counterpart for Saudi Food and Drug Authority (SFDA), has added a Boxed Warning to the label for Plavix, the anti-blood clotting medication. The Boxed Warning is about patients who do not effectively metabolize the drug (i.e. "poor metabolizers") and therefore may not receive the full benefits of the drug.

The U.S. Food and Drug Administration (FDA) is evaluating clinical trial data that may suggest that patients taking Stalevo, a Parkinson's disease medication, may be at an increased risk for developing prostate cancer. In this trial, patients taking Stalevo were compared to those taking carbidopa and levodopa (sold as Sinemet), a combination medication also used to treat Parkinson's disease.
At this time, FDA's review of Stalevo is ongoing and no new conclusions or recommendations about the use of this drug have been made.

The Saudi Food and Drug Authority (SFDA) has revised the labels for a class of drugs known as proton pump inhibitors (PPIs) to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications at higher doses or long duration (more than one year).

The Saudi Food and Drug Authority (SFDA) notifies healthcare professionals of changes to the Warnings section of the prescribing information for tramadol, a centrally acting synthetic opioid analgesic indicated for the management of moderate to moderately severe chronic pain. The strengthened Warnings information was based on several reports Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs.

The Journal of the American Medical Association published a randomized controlled trial on April 28, 2010 that found the administration of B-vitamins failed to slow the progression of diabetic nephropathy and was associated with an increase in vascular events. The trial was stopped early for safety reasons.1

 In view of its role of monitoring and control and in implementation of its mission of ensuring safety , quality and efficacy of drugs & safety of health products; SFDA observed that several health and herbal products are being illegally marketed through TV Channels, SMS or Advertisements wherein consumers are attracted by the ability of such products to reduce high percentage of  weight in a short period of time.

​Saudi Food and Drug Authority represented by the medical devices sector  would like to warn all  healthcare practitioners from using OneTouch® Verio® Pro+ blood glucose meters (hospital and clinics use), manufactured by Lifescan Johnson & Johnson company due to incorrect test results stored in results log at extremely high blood glucose levels  above 1023 mg/dL (56.83 mmol/l).
SFDA has become aware through Lifescan Johnson & Johnson that recalling and replacing all OneTouch Verio Pro+ blood glucose meters because: