new Risk Evaluation and Mitigation Strategy (REMS) to reduce the misuse of long-acting opioids

June 2011

FDA will encourage you to participate in a new Risk Evaluation and Mitigation Strategy (REMS) to reduce the misuse of long-acting opioids.

Unintentional deaths due to opioids have quadrupled in 8 years...and treatment for opioid abuse has increased five-fold in 10 years.

Now FDA will require manufacturers to come up with a REMS plan by mid-August...with the changes rolled out by early 2012.

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Table of Contents

Cardiology HIGHER blood pressure goals in some elderly patients
Dyslipidemia less reliance on fibrates for high triglycerides
Women's Health Is it okay for women to use OTC emergency contraceptives (Plan B, etc) repeatedly as their primary contraceptive
Diabetes pregabalin (Lyrica) as "preferred" for treating painful neuropathy in diabetes patients
Psychiatry more emphasis on the treatment of bipolar disorder
Diabetes Tradjenta (TRAD-gen-ta), a new gliptin for type 2 diabetes
Anticoagulants using Pradaxa (dabigatran) for more than atrial fibrillation
Neurology & Pain what to use for headaches now that Midrin and its equivalents are gone
Neurology & Pain new Risk Evaluation and Mitigation Strategy (REMS) to reduce the misuse of long-acting opioids
Pediatrics whether PPIs (omeprazole, etc) are useful for treating gastroesophageal reflux in infants
EHRs "meaningful use" of electronic health records (EHRs) as incentive dollars start being paid out
Drug Interactions Zyrtec ads that warn against taking Allegra with orange juice are raising questions about a new kind of fruit juice interaction
Restless Legs new option for restless legs syndrome, Horizant (hor-i-zant)