October, 24th , 2007, US FDA, the American's equivalent of the Saudi Food and Drug Authority (SFDA), updated the prescribing information for Provigil (modafinil).
Provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.
Riyadh October 2007 – The Saudi Ministry of Health has withdrawn the marketing approval for two cough syrups, Orcinol and Silomat, containing clobutinol. The withdrawal in Saudi Arabia is in response to a similar action taken by the European Medicine Agency (EMEA) to ban clobutinol in the European Union. The Saudi Food and Drug Authority (SFDA) agrees with the Ministry of Health’s decision to protect the public health.
November, 1st , 2007, Health Canada, the Canadian equivalent to the Saudi Food and Drug Authority (SFDA), announced new restrictions on the use of Rosiglitazone containing products due to cardiac safety concerns (Avandia, Avandamet, Avandaryl)
Rosiglitazone-containing products are used in the treatment of type 2 diabetes mellitus.
Epilepsy, antiepileptic drugs (AEDs), and reproductive endocrine function have complex interactions. In this study, we wanted to investigate the effects of AEDs on reproductive endocrine function after withdrawal of AEDs and look for reversible endocrine effects.
November 14, 2007, the US Food and drug Administration, the American's equivalent to the Saudi Food and Drug Authority (SFDA), announced ongoing review of safety information of cefepime marketed as Maxipime. Cefepime is a broad spectrum cephalosporin antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. It is a member of the class of antibiotics known as β–lactams .
On November 16, 2007, the European Medicine Agency (EMEA), the European's equivalent to the Saudi Food and Drug Authority (SFDA), has recommended the suspension of marketing authorisations for all medicinal products containing carisoprodol. This product is marketed in Saudi Arabia as Somadril. Carisoprodol is mainly used for the treatment of acute (Short-Lived) lower back pain.
Bisphosphonate therapy is the current standard of care for the prevention and treatment of glucocorticoid-induced osteoporosis. Studies of anabolic therapy in patients who are receiving long-term glucocorticoids and are at high risk for fracture are lacking.
November 27, 2007 – The U.S Food and Drug Administration (FDA), the equivalents of the Saudi Food and Drug Authority (SFDA), announced that Novartis issued a Dear Healthcare Professional Letter to inform them that use of Myfortic Delayed Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations
Dual-antiplatelet therapy with aspirin and a thienopyridine is a cornerstone of treatment , to prevent thrombotic complications of acute coronary syndromes and percutaneous coronary intervention.
To compare prasugrel, a new thienopyridine, with clopidogrel, we randomly assigned
13,608 patients with moderate-to-high-risk acute coronary syndromes with scheduled
percutaneous coronary intervention to receive prasugrel (a 60-mg loading dose