The panic continues. 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
It is not surprising that the drug cannot be deemed “safe” with such a small patient sample.
The FDA also reports that 10 percent of all human subjects experienced adverse events including four percent who received the 200 mg dose and seventeen 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.