Diabetes Linked to Statins Reuters (3/27, Berkrot) reports the US FDA stated that there will be a change in safety information on labels of statins indicating that these drugs may cause an increase in blood sugar and possible memory loss. In a statement, Amy Egan, deputy director for safety in FDA’s Division of Metabolism and Endocrinology [...]
Defects in St. Jude Heart Device
Heart Device Wires by St. Jude’s Found Faulty St. Jude’s recalled Riata wires, the wires used to connect life saving defibrillators, because they have been found to short circuit and melt conductors. These defects may not be as dangerous as actually removing the wires. The American College of Cardiology reports that the wires put off a [...]
New Law Could Limit FDA Testing
New Law Could Allow FDA To Approve Medical Devices Without Going Through Approval Process A new law on the books could allow the “FDA to approve a new medical device if it is similar to an existing, previously approved device, even if that older device has been recalled because of safety problems. This means that [...]
Mixing Certain Foods And Drugs With Supplements May Be Harmful
Certain Food/Supplement Combos Could Be Dangerous Many of us do not think twice as we pop our daily vitamin, antibiotic and cholesterol pills with our morning glass of juice. However, studies show that we need to be more cautious and thoughtful of the foods and drugs or supplements we are mixing together. Some food and drug [...]
Misunderstanding Medicine Labels pose serious issue for elderly
Misreading medicine labels put elderly at risk of dying According to researchers a University of College London, a third of the 8000 elderly patients in a study had an increased rate of dying due to misunderstanding medicine labels. The study asked comprehension style questions such as ‘What is the maximum number of days you may [...]
FDA evaluating reports of serious side effects of Pradaxa
Pradaxa Side Effects The FDA is evaluating reports of serious bleeding in Pradaxa patients. Pradaxa is a blood thinner used tho help prevent stroke in heart patients. Bleeding may lead to serious consequences while on Pradaxa. The label contains a warning about “significant and sometimes fatal bleeds”. As of now, FDA advices patients to continue [...]
Lack of regulations allow for counterfeit medications to gain global growth
Regulators have few ways to prevent fake medicines from reaching patients. Reuters (3/12, Berkrot) Lack of regulations make it hard to stop fake medications from getting to patients, and laws seeking to help may be years from enacted. Criminal and terrorist organizations are lured to counterfeit drug trade due to smaller penalties than illegal drug running. [...]
More FDA Warnings for Zocar, Lipitor and Crestor
Medscape (3/2, Lowes) reports, “The US Food and Drug Administration (FDA) today announced that it is revising the labels of certain statins as well as protease inhibitors for HIV and hepatitis C virus (HCV) to warn about interactions between the 2 sets of drugs that could increase the risk for myopathy and kidney failure.” The Article [...]
Counterfeit Avastin Under Investigation
On its front page, the Wall Street Journal (3/7, A1, Whalen, Faucon, Subscription Publication) reports that, according to investigators and documents it has examined, authorities looking into the importation of low cost foreign drugs into the US have linked a Canadian drug supplier that may have shipped the counterfeit bevacizumab [Avastin] into the US. Federal officials are [...]
Automatic External Defibrillators Categorized As A Class One Recall
HeartWire (3/6, Miller) reports, “The Food and Drug Administration is reminding owners of automatic external defibrillators (AEDs) to check whether their devices are subject to a January recall.” The FDA announced at that time that “certain lots of AEDs manufactured by several companies contain a defective component that may fail unexpectedly.” The recall is categorized as [...]