Although the FDA review discounted an excess bleeding risk with dabigatran, it did not address another potential concern — the ability to reverse the anticoagulant effect acutely in cases of emergency.
Antman acknowledged that there is no specific, approved antidote for dabigatran or any of the novel anticoagulants, although it is an area of active investigation and the topic of several studies that will be presented at the AHA meeting in the coming days.
He said it’s not true, however, that clinicians don’t have any options. Intravenous administration of blood coagulation factors — prothrombin complex concentrates that are available in every hospital — can help to reverse the effect, though not completely.
In comparison, the effects of warfarin can be reversed with the administration of vitamin K. Antman noted. But that that doesn’t always work either, and patients can die because of it, he added.
Pharma
Linzess – Think IBS with Constipation
Linzess is felt to act as a guanylate cyclase-C agonist. An agonist increases the activity of a process, the opposite of an antagonist. Linzess seems to act locally on the surface of the inside of the intestinal lining cells and by activation of guanylate cyclase-C increases levels of intracellular cGMP (cyclic guanosine monophosphate) which results in increased levels of chloride and bicarbonate in the intestinal lumen and speeds up gastrointestinal transit.
Mirapex (pramipexole) Possible Risk of Heart Failure
ISSUE: FDA notified healthcare profesionals about a possible increased risk of heart failure with Mirapex (pramipexole). Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, FDA is not able to determine whether Mirapex increases the risk of heart failure. FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with Mirapex and will update the public when more information is available.
ADHD drug from Targacept Phase 2 Clinical Trial Failure
The drug known as TC-5619 failed to show enough evidence of effectiveness against inattentive-predominant ADHD. The Winston-Salem-based company said it will have to reduce its employee count to save money, but it did not announce how many jobs will be affected.
Reumofan Plus – Why You Should Not Buy Nor Use This Supplement
BACKGROUND: Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.
Since June 1, 2012, when FDA first warned the public about the dangers of these supplements, the agency has received reports of fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndrome
via Safety Alerts for Human Medical Products > Reumofan Plus: Recall – Undeclared Drug Ingredient.
FDA OKs Generic Actos for Type 2 Diabetes
The FDA today approved the first generic version of Actos to treat adults with type 2 diabetes.
The generic tablets use the same active ingredient as Actos, called pioglitazone, to improve blood glucose control in adults with type 2 diabetes.
Ampyra (dalfampridine) – Seizure Risk for Multiple Sclerosis Patients
BACKGROUND: Ampyra was approved to improve walking in patients with MS. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug. Ampyra is eliminated from the body through the kidneys, and patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk.
Any Advantages Or Is Livalo Just One More Statin? | DrPullen.com – Medical and Health Blog
Livalo has a number of things going against it and at this point I cannot think of a single reason I would prescribe it unless someone can show it to have unique benefits as compared to more established statins.
Any Advantages Or Is Livalo Just One More Statin? | DrPullen.com – Medical and Health Blog.
eHealthMe – Real World Drug Outcomes
eHealthMe – Real World Drug Outcomes, Personalized.
Underwriters rejoice! Check out this website devoted to drug interactions and side effects. I will also put a link in my Blogroll sidebar.
ADHD Drugs Top Rx for Kids
Prescription drug use in the pediatric population fell from 2002 to 2010, but the use of birth control and attention-deficit/hyperactivity disorder (ADHD) medications rose, the FDA reported.
Outpatient contraceptive prescriptions jumped 93% from 2002 to 2010 among kids 17 and younger, Grace Chai, PharmD, of the agency’s Center for Drug Evaluation and Research in Silver Spring, Md., and colleagues found.
ADHD drug scripts rose 46% over the same period in the national analysis of prescription databases reported in the July issue of Pediatrics.
via Medical News: FDA: ADHD Drugs Top Rx for Kids – in Pediatrics, General Pediatrics from MedPage Today.
Birth control and chronic sedation have replaced traditional parenting.
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