In agreement with European Regulatory Authorities, GlaxoSmithKline (GSK) is informing you of recent safety data concerning rosiglitazone-containing products, i.e., Avandia® (rosiglitazone maleate) Tablets, Avandamet® (rosiglitazone maleate and metformin hydrochloride) Tablets, and Avaglim® (rosiglitazone maleate and glimepiride) Tablets. The information could be summarized as follows:

Amgen notified the oncology medical community of the results of a large, multicenter, randomized, placebo-controlled study showing that Aranesp ® (Darbepoetin alfa) was ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who have anemia that is not due to concurrent chemotherapy.

Takeda and FDA notified healthcare professionals of recent safety data concerning pioglitazone-containing products. The results of an analysis of the manufacturer's clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a comparator (either placebo or active). The majority of fractures observed in female patients were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia).

The Singapore Health Sciences Authority found Urat Madu capsules to be adulterated with the prescription drug sildenafil. Sildenafil citrate is indicated for the treatment of erectile dysfunction, and has been associated with serious adverse reactions. Sildenafil is not intended for self-care, and should only be taken under the guidance of a health care professional.

The U.S. Food & Drug Administration (FDA) is launching a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane) online. Isotretinoin is a drug approved for the treatment of severe recalcitrant nodular acne that does not respond to antibiotics. Improperly used, isotretinoin can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.

A U.S. Food and Drug Administration advisory panel on Thursday called for new warnings and additional safety studies on anemia drugs commonly used to treat patients undergoing kidney dialysis or chemotherapy.

These medications have been the subject of controversy since some of their dangerous side effects -- including the risk of heart attacks and stroke -- came to light earlier this year. In March, the FDA issued stronger label warnings for the popular drugs.

The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

The Hong Kong Department of Health (HKDH) found Xiaokeshuping Jiangtangning Jiaonang capsules to contain the undeclared pharmaceutical drugs phenformin, rosiglitazone, and glibenclamide, which may be used in diabetes to lower blood sugar. The HKDH conducted the analysis following receipt of a report that one woman in China had been hospitalized due to a serious hypoglycaemic attack (very low blood sugar) after using Xiaokeshuping Jiangtangning Jiaonang.

حذر خبراء في الصيدلة من الادعاءات التي يسوق لها أصحاب محلات العطارة لمنتجات عشبية (سامة)، ومستحضرات ضارة بالصحة.

وأكدوا ل"الرياض": أن حجر السعادة(حجر جهنم) والذي يؤكد المسوقون له بأنه علاج فعال ومضمون ولا يوجد له محاذير طبية، هو عبارة عن مجموعة من المواد الصمغية والتي تحتوي على مواد سامة لها آثار جانبية ضارة تؤدي إلى تليف الكبد، ومواد مهلوسة محظورة دوليا.

ويأتي هذا التحذير في الوقت الذي تسوق محلات العطارة لأعشاب وأدوية لمعالجة جميع الأمراض، في ظل غياب الجهات الرقابية.