News you can use: health & drug safety updates
September 28, 2008
Click the link to Listen to Podcast!
September 16, 2008
FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in IndiaThe Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy’s Dewas and Paonta Sahib plants in India. The Warning Letters identify the agency’s concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import
September 12, 2008
The Kaiser Family Foundation issued an updated fact sheet on Prescription Drug Trends. This updated fact sheet provides trend information about prescription drug expenditures and coverage, key factors that contribute to rising prescription spending, and efforts to contain certain rising drug costs.
September 3, 2008
to provide information for consumers and industry about how FDA regulates the promotion of medical products. The sites are:
- The “Advertising Prescription Drugs and Medical Devices” - this site provides a “one-stop shop” portal to information on FDA regulation of medical product promotion. Industry and policy users can get directly to relevant laws, regulations, and guidances.
- The “
September 1, 2008
PharmaVoice - View on Marketing
September 1, 2008
Dow Friends Page 17
July 9, 2008
Researchers at the University of North Carolina at Chapel Hill Eshelman School of Pharmacy have created a list of prescription drugs that increase the risk of falling for patients aged 65 and older who take four or more medications on a regular basis. The medications on the list cover a wide range of common prescription antidepressants, seizure medications, painkillers and more. The common denominator among them is that they all work to depress the central nervous system, which can make patients less alert and slower to react.
July 8, 2008
The Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. The agency also: 1) determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects, and 2) issued Information for Health Care Professionals today to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these
June 23, 2008
AHRQ released a new pair of plain-language guides to compare medications for the treatment of osteoporosis, including clinical benefits, risks, and cost estimates. Osteoporosis Treatments That Help Prevent Broken Bones, A Guide for Women After Menopause, and Fracture Prevention Treatments for Postmenopausal Women with Osteoporosis, a guide for clinicians. The consumer and clinician guides include basic facts about osteoporosis (also known as low bone density) and the medications commonly used in treatment. Among the medications analyzed are six
June 17, 2008
The Arizona Center for Education and Research on Therapeutics, a national center for improving medication safety,* has new medication record forms available in English and Spanish. These forms can be printed and filled in by hand, or completed online and downloaded as a PDF to store on personal computers. Consumers are urged to use medication record forms to keep an up-to-date record of all the medicines and dietary supplements they take and show it to their doctor or pharmacist at each visit. This record is an important tool in routine health care,