Here are some safety advisory and news for your speed update.
•    HSA Warns Against Taking "The New Millennium Male Horse Power Capsule"
•    US FDA Drug Safety Advice on Erythropoiesis-Stimulating Agents (ESAs)
•    Simvastatin: increased risk of muscle injury with high doses

•    HSA Warns Against Taking "The New Millennium Male Horse Power Capsule"
The Health Sciences Authority (HSA) has detected two undeclared potent substances, in a complementary health product labelled “The New Millennium Male Horse Power Capsule” which claims to be a“natural aphrodisiac and strength enhancer”. The undeclared substances, yohimbine and dehydroepiandrosterone (DHEA), can cause serious side effects when consumed without professional medical supervision.
For more information and the packshot of the product, please read here.

http://www.hsa.gov.sg/publish/etc/medialib/hsa?library/corporate/press?r...


•    US FDA Drug Safety Advice on Erythropoiesis-Stimulating Agents (ESAs)
FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving an ESA. Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program. FDA is requiring a REMS because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions.

Read the complete MedWatch 2010 Safety summary including links to the Drug Safety Communication and current Prescribing Information for these products, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...


•    Simvastatin: increased risk of muscle injury with high doses
Simvastatin is sold as a single-ingredient generic medication and as the brand-name, Zocor. It is also sold in combination with ezetimibe as Vytorin; and niacin as Simcor.
FDA notified healthcare professionals and patients that, based on review of data from a large clinical trial and other sources, there is an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class. FDA is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury.
Recommendations for healthcare professionals, recommendations for patients and a data summary of information used in this ongoing review are provided in the Drug Safety Communication.
Read the complete MedWatch 2010 Safety summary, including a link to the Safety Communication and current Prescribing Information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

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