Pharma push for Medicare donut hole change tangles opioid negotiations

A push by Big Pharma to claw back Medicare Part D donut hole money as part of the opioids package has hit against sharp Democratic opposition.  READ MORE

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

In a Dear Veterinarian Letter issued today, the U.S. Food and Drug Administration reminded veterinarians of the differences between Mirataz (mirtazapine transdermal ointment), an animal drug that the FDA approved in May 2018 with demonstrated safety and effectiveness to manage undesired weight loss in cats, compared to the use of compounded formulations of transdermal mirtazapine, which some veterinarians started prescribing before there was an FDA-approved product available. FDA approval of this drug means that veterinarians have an approved mirtazapine product with known safety, efficacy, and quality to provide to their patients rather than relying on the only previously available products that are compounded from bulk drug substances that are unapproved animal drugs. Unlike FDA-approved Mirataz, compounded formulations of transdermal mirtazapine have not been reviewed by the FDA for safety or effectiveness and may vary in quality and potency. With many compounded transdermal drugs, the rate and degree of absorption are unknown and may vary to deliver too little or too much of the active ingredient, making treatment outcomes unpredictable. Manufactured for Kindred Biosciences Inc., Mirataz is a prescription animal drug that is intended to be applied topically on the inner surface of the cat’s ear once daily for 14 days. Mirataz must be prescribed by a licensed veterinarian because a trained professional is needed to correctly diagnose the cause of weight loss in cats and determine whether the drug is an appropriate treatment. Press Release

Essential! High Importance! Must Read!! Blindsided:At Least 68 People Are Nearly Blind After A Botched Drug Was Injected Into Their Eyeballs Their tragedies expose a shadowy US industry that sells drugs with little government oversight. by Stephanie M. Lee

https://www.buzzfeednews.com/article/stephaniemlee/guardian-pharmacy-compounding-lawsuits-cataracts

Animal Drug Safety Communication: FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events Associated with Certain Flea and Tick Products

The U.S. Food and Drug Administration is alerting pet owners and veterinarians to be aware of the potential for neurologic adverse events in dogs and cats when treated with drugs that are in the isoxazoline class. Since these products have obtained their respective FDA approvals, data received by the agency as part of its routine post-marketing activities indicates that some animals receiving Bravecto, Nexgard or Simparica have experienced adverse events such as muscle tremors, ataxia, and seizures. Another product in this class, Credelio, recently received FDA approval. These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations. The FDA is working with manufacturers of isoxazoline products to include new label information to highlight neurologic events because these events were seen consistently across the isoxazoline class of products. See more…

Is CBD illegal? Pharmacy board says yes, but dozens of stores sell it

WLWT Cincinnati-17 hours ago

The spokeswoman for the state's Board of Pharmacy told Dykes that the agency is not taking enforcement action at this point against stores selling CBD products ...

Local stores sell CBD despite state order
Athens NEWS-14 hours ago

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