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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting, July 18, 2013

Public Summary

The following Drug Safety Communications (DSCs) have posted since the May 16, 2013 DSB meeting:

  • May 30, 2013: Magnesium Sulfate – FDA is advising health care professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant women. This use of the drug is off-label, which means that it is not an FDA-approved use of the drug. Administration of magnesium sulfate injection to pregnant women longer than 5-7 days may lead to low calcium levels and bone problems in the developing baby or fetus, including thin bones, called osteopenia, and bone breaks, called fractures. The shortest duration of treatment that can result in harm to the baby is not known. 
  • June 18, 2013: Zyprexa Relprevv (olanzapine pamoate) – FDA is notifying the public that it is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv. The patients died 3-4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS). Both patients were found to have very high olanzapine blood levels after death. High doses of olanzapine can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced level of consciousness ranging from sedation to coma.
  • July 3, 2013: Benicar, Benicar HCT, Azor, Tribenzor, and generics (olmesartan medoxomil) – FDA is notifying the public that the anti-hypertensive agent olmesartan medoxomil, an angiotensin II receptor blocker (ARB), can cause intestinal problems known as sprue-like enteropathy. FDA has approved changes to the labels of these drugs to include this concern. angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs. Sprue-like enteropathy has not been detected with ARBS other than olmesartan. http://www.fda.gov/Drugs/DrugSafety/ucm359477.htm

The DSB heard one presentation:

Healthy People 2020

Dale Slavin, Acting Director of CDER’s Safe Use Initiative and Dan Budnitz, Director of CDC’s Medication Safety Program presented on Healthy People 2020. Healthy People is a program of nationwide health-promotion and disease-prevention goals set by the United States Department of Health and Human Services. Healthy People provides science-based, 10-year national objectives for improving the health of all Americans.

There are over 40 different Healthy People 2020 workgroups each with their own set of objectives. FDA leads the Medical Product Safety (MPS) work group and is joined by CDC on the work group.

The MPS objectives for 2020 focus on overall improvement of patient treatment and appropriate use of medical products. Medical products include drugs, biological products, and medical devices. These objectives reflect strong scientific support for safe use of medical products, which promote better health among Americans. The purpose of the discussion at the DSB was to solicit the Board’s thoughts regarding the objectives for medical product safety, as well as the data sources suggested as a means of obtaining those objectives.