The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved an extension of indication for oseltamivir (Tamiflu®) to include treatment of children less than 6 months of age during pandemic influenza and post-exposure prophylaxis for children less than 1 year of age. In parallel the Committee has approved instructions to prepare home and pharmacy extemporaneous formulations from Tamiflu 30, 45 and 75mg capsules and dosing recommendations from these extemporaneous formulations for children under 1 year of age.

The U.S. Food and Drug Administration, the American counterpart to the Saudi Food and Drug Authority (SFDA) is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products.

Sitagliptin, the first in a new class of diabetic drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

Riyadh October 11, 2009 – The U.S. Food and Drug Administration (FDA), the American counterpart to the Saudi Food and Drug Authority (SFDA) and GlaxoSmithKline (GSK) notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.

FDA notified healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products, describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine. The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.

FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed.

Genentech and The U.S. Food and Drug Administration, the American counterpart to the Saudi Food and Drug Authority (SFDA) notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with rituximab who has not previously received treatment with a TNF antagonist.

أصدرت الهيئات الرقابية العالمية في بريطانيا والولايات المتحدة ووكالة الأدوية الأوربية ( EMEA ) المعنية بالدول الأعضاء في الاتحاد الأوربي عدة بيانات حول مأمونية لقاحات أنفلونزا الخنازير (A-H1N1) بعد استخدامها في الفترة السابقة، وذلك بعد ما يقارب الثلاثة أشهر من ترخيص واستخدام هذه اللقاحات، حيث أخذ جانب الأمان لهذه اللقاحات أبعادا كثيرة وحيزا كبيرا من الطرح سواء على الجانب الشعبي أو على المستوى الإعلامي المحلي المرئي منه والمقروء.

The SFDA is Reviewing the Cardiovascular Safety of rosiglitazone (Avandia)

The Saudi Food and Drug Authority (SFDA) notifies healthcare professionals and patients that it is reviewing data obtained from the clinical trials, meta-analyses and observational studies which address the cardiovascular safety profile of rosiglitazone.

Deferasirox is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) in patients with beta thalassemia major aged 6 years and older. Deferasirox is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: