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Provigil (modafinil) Prescribing Information Updates

2007-10-31

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.


Other Awareness Article

POSSIBLE HEART RHYTHM DISTURBANCE WITH THE COUGH PREPARATIONS ORCINOL AND SILOMAT

2007-11-07

Riyadh October 2007 – The Saudi Ministry of Health has withdrawn the marketing approval for two cough syrups, Orcinol and Silomat, containing clobutinol.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.


Other Awareness Article

Rosiglitazone (AVANDIA, AVANDAMET and AVANDARYL)Safety Information Update

2007-11-10

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.


Other Awareness Article

Long-Term Effects of Caffeine Therapy for Apnea of Prematurity

2007-11-14

Methylxanthine therapy is commonly used for apnea of prematurity but in the absence of adequate data on its efficacy and safety. It is uncertain whether methylxanthines have long-term effects on neurodevelopment and growth.


Other Awareness Article

Reversible Effects of Antiepileptic Drugs on Reproductive Endocrine Function in Men and Women with Epilepsy—A Prospective Randomized Double-Blind Withdrawal Study

2007-11-14

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.


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Ongoing Safety review of Cefepime By US FDA

2007-11-20

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 .


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EMEA recommends suspension of carisoprodol-containing products

2007-11-20

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.


Other Awareness Article

Teriparatide or Alendronate in Glucocorticoid-Induced Osteoporosis

2007-11-28

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.


Other Awareness Article

Myfortic (mycophenolic acid) Delayed-Release Tablets Safety Information Update

2007-12-05

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


Other Awareness Article

Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes

2007-12-05

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


Other Awareness Article

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