Only Pregnant Animals Tested With Peramivir For H1N1 Virus
Nov 6, 2009 
Linda Burke-Galloway, M.D.--
The FDA had granted the use of unapproved drugs in the treatment of the 2009 H1N1 Influenza virus. Through an Emergency Use Authorization (EUA), the experimental drug, Peramivir has been allowed to treat hospitalized patients with H1N1 influenza that includes pregnant women, babies and children up to age 17. Peramivir is not approved by the FDA for use in the U.S. because its patient safety has not been established.
Peramivir is an antiviral medication, similar to Tamiflu® and Relenza® but is given in the veins. It is helpful for patients who are unable to swallow meds, have an allergy to Tamiflu® or Relenza® or are not responding to oral or nasal medication. However, treatment with Peramivir should be considered a “Hail Mary Pass.” It is used when all else has failed. While the FDA believes that known and potential benefits of Peramivir outweigh its known and potential risks, a closer look at the FDA’s statistics is on order.
According to the Emergency Use Authorization of Peramivir IV Fact Sheet for Health Care Providers the following statistics are enlightening:
- Only 1,891 clinical trials patients in the US were given any form of the drug
- Out of 1,891 patients tested, NONE were children, pregnant women or nursing mothers
- Out of the 1,891 clinical trial patients, only 478 received a “single-dose” regimen similar to what might be given in a hospital setting
- Out of 1,891 patients, only 33 patients received a 600 mg dose for five days or greater
Pregnant women were excluded from the study however pregnant rats and rabbits were not. Listed below are their findings:
- There were no birth defects in either pregnant rats or rabbits
- Pregnant rabbits experienced kidney problems at a 200 mg dose and an increased incidence of spontaneous miscarriages
- A 600 mg dose did not affect the kidneys of pregnant rats
- Small amounts of the drug was found in the breast milk of pregnant rats
The FDA reports that 10 percent of all human subjects experienced adverse events including 4 percent who received the 200 mg dose and 17 percent who received the 400 mg dose. The most frequent adverse reaction was pneumonia. The FDA recommends a 5-to-10 day treatment of Peramivir 600 mg given once per day.
Let’s hope we will remain healthy and never have the need for Peramirvir. However knowledge is power. At least we now have the facts.
Linda Burke-Galloway, MD, MS, FACOG is a board-certified ob-gyn physician who is a champion of patient safety and is on a mission to keep pregnant women from falling through the cracks of our imperfect healthcare system. For over twenty years she has provided clinical services to high-risk pregnant women in medically underserved communities. She served our country through the National Health Service Corp, is a medical malpractice consultant for the U.S. Human Health Services and the federal government has also sought her expertise in reducing obstetrical malpractice cases in high-risk communities. Dr. Burke-Galloway has worked for the State of Florida Department of Health for over thirteen years in direct patient care. She is the author of The Smart Mothers Guide to a Better Pregnancy and is the Pregnancy Expert for LifeScript.com. She is a graduate of City College of the City University of New York, Columbia University School of Social Work and Boston University School of Medicine. She lives with her husband in Central Florida and is the proud mother of two sons. Dr. Galloway is the author of The Smart Mother's Guide to a Better Pregnancy (Red Flags Pub/ 2008). You'll find Dr. Galloway online at www.smartmothersguide.com
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