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An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

Rheumatology Drug Updates, Trials, Safety Data

  |  Issue: April 2014  |  

The FDA is investigating heart attack, stroke and death risk in men taking FDA-approved testosterone products.6 This comes after recent publication of two different studies that both suggested an increased cardiovascular risk among groups of men prescribed testosterone therapies. The FDA continues to evaluate the information from these studies, and other available data while it is providing this alert to healthcare practitioners. Any conclusions and recommendations will be communicated following completion of the evaluation. Healthcare professionals are encouraged to report adverse effects or side effects related to testosterone—or other products—to the FDA at http://www.fda.gov/MedWatch/report.htm.

Michele B Kaufman, PharmD, BSc, RPh, is a freelance medical writer, a pharmacist at New York Presbyterian, Lower Manhattan Hospital, and adjunct faculty at Touro College of Pharmacy in New York City.

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References

  1. Promising phase IIb data on clazakizumab in patients with moderate-to-severe rheumatoid arthritis to be presented at the 2013 Annual Meeting of the America College of Rheumatology Oct. 28, 2013. http://news.bms.com/press-release/financial-news/promising-phase-iib-data-clazakizumab-patients-moderate-severe-rheumato. Last accessed Feb. 25, 2014.
  2. Epratuzumab. Immunomedics. http://www.immunomedics.com/epratuzumab.shtml. Last accessed Feb. 25, 2014.
  3. UCB product pipeline. Last updated Feb. 7, 2014. http://www.ucb.com/rd/pipeline/new-development. Last accessed Feb. 25, 2014.
  4. McClung MR, Grauer A, Boonen S, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014;370:412–420.
  5. FDA recommends health care professionals discontinue prescribing and dispensing prescription combination drug products with more than 325 mg of acetaminophen to protect consumers Jan. 14, 2104. http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm381650.htm. Last accessed Feb. 25, 2014.
  6. Testosterone products: Drug safety communication—FDA investigating risk of cardiovascular events. Jan. 31, 2014. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm384225.htm. Last accessed Feb. 25, 2014.

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