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  5. Drug Safety Oversight Board Meeting, July 17, 2014
  1. Center for Drug Evaluation and Research | CDER

Drug Safety Oversight Board Meeting, July 17, 2014

Public Summary

The following Drug Safety Communications (DSCs) have posted since the May 15, 2014 DSB meeting:

  • May 15, 2014: Lunesta (eszopiclone) - FDA is warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness. As a result, FDA has decreased the recommended starting dose of Lunesta to 1 mg at bedtime. Health care professionals should follow the new dosing recommendations when starting patients on Lunesta. Patients should continue taking their prescribed dose of Lunesta and contact their health care professionals to ask about the most appropriate dose for them.
  • June 20, 2014:  Taxotere (docetaxel) – FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. FDA is revising the labels of all docetaxel drug products to warn about this risk. Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications. 
  • June 24, 2014:  Benicar (olmesartan) – FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients. As a result, FDA’s recommendations for use of olmesartan (Benicar, Benicar HCT, Azor, Tribenzor, and generics) will remain the same, but FDA will require information about some of the studies to be included in the drug labels. Patients should discuss any questions they have with their health care professionals.  
  • June 25, 2014:  OTC Topical Acne Products – FDA is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching.  
  • June 26, 2014:  Viscous Lidocaine Products – FDA is warning that prescription oral viscous lidocaine two percent solution should not be used to treat infants and children with teething pain. FDA is requiring a new Boxed Warning, FDA’s strongest warning, to be added to the drug label to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.  

The Board heard four presentations:

  1. Mary Ross Southworth, PharmD, Deputy Director for Safety, DCRP/CDER discussed with the Board the postmarketing experience thus far with the non-Vitamin K antagonist oral anticoagulants (NOACs), including a review of the ongoing postmarketing surveillance for dabigatran and the two other NOACs, rivaroxaban and apixaban.
  2. David Graham, MD, MPH, OSE/CDER presented the results of a study of elderly Medicare beneficiaries looking at bleeding risks in patients treated with warfarin or dabigatran.
  3. Marsha Reichman, PhD, CDER Sentinel Initiative Lead, OPE/OSE/CDER, presented the results comparing the outcomes of GI hemorrhage and intracranial hemorrhage in new users of dabigatran and warfarin across the Mini-Sentinel Modular program, the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study, and the CMS Medicare Epidemiologic Study.
  4. Fran Cunningham, PharmD, Director, Center for Medication Safety, VA presented an overview of the surveillance program in place at the VA for the NOACs, dabigatran and rivaroxaban.

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or institution.


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