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…

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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
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ST. LOUIS • A St. Louis pharmacist pleaded guilty Tuesday to federal charges in two separate cases and admitted a role in a kickback conspiracy and also ...

PharMEDium says compounder misinterpreting law to compete with Endo

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Australian Journal of Pharmacy (blog)-1 hour ago

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Very High Importance!! Doctor disciplined by California medical board for menopause therapy: The therapy Dr Hall was prescribing is known as bio-identical hormones which are extolled as a ‘safer’ alternative to traditional hormone replacement therapy.

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Posted: 18 Sep 2018 06:53 PM PDT

By Anne K. Walsh —

From Serialization to Full Traceability: 2018 Outlook On Compliance

In just two months, pharmaceuticals entering the US pharma supply chain through drug manufacturers will be serialized according to the Drug Supply Chain Security Act(DSCSA).  It’s already been a long journey, but this is only the beginning.  Companies can’t even take a break.  In just one year the wholesale distributor saleable returns requirement will force manufacturers to either capture aggregation data or connect to a Verification Router Service (VRS)—or both!  The year after that, dispenser requirements will lead to even more verification requests coming through.  And...

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