FDA Added Warning Label to Tamiflu In 2006: Can Cause Suicidal Thoughts, Loss of Consciousness and More
As many of you know, on October 23, 2009, President Obama made the swine flu a national medical emergency. Now that the swine flu has spread to 46 states, Administration officials made a pro-active move to assist medical officials in making swifter decisions for treatment.
Effectiveness of Tamiflu and Relenza In Question
Let’s back up for a moment, on April 26, 2009 when the Administration declared the swine flu a public health emergency, they allowed the shipment of roughly 12 million doses of flu-fighting medications from a federal stockpile to states in case they eventually needed them. These stockpiled flu-fighting medications were two antiviral treatments, Tamiflu (oseltamavir) and Relenza (zanamivir). Part of the reason for the use of these particular medications was due to the massive government stockpiles of these drugs that occurred in preparation for the bird flu (2006) that never came about and is due to expire by 2010. In response to this problem, the Food and Drug Administration (FDA) has determined and authorized the use of these medications beyond their expiration dates under Emergency Use Authorization. With the expiration of these drugs nearing, many would wonder how effective these medications would be.
Is It Worth It?
In a recent study conducted by Oxford University, questions arose to the previous studies done on the effectiveness of these medications and state that the risks are likely to outweigh the very slight benefits. (See full study). The study researched the effects in treating children (under the age of 12) with Tamiflu and Relenza. The results were modest at best. The drugs were found to reduce the duration of the flu by a day. However, complications such as asthma, or the need to use antibiotics due to secondary infections were not alleviated. This data alone suggests benefits are very weak and offer far less protection than basic proactive medical care such as vitamins, rest and continuous hand washing. According to the study, a full level treatment dose needs to be given to 13 children simply to prevent one case of the flu.
Unrelated to this study, the FDA added a warning label to Tamiflu and Relenza back in November of 2006, based on numerous reports of delirium and suicide mostly in children under 17. Side effects occurred within 24-48 hours of taking the drug and included panic attacks, delusions, delirium, convulsions, depression, loss of consciousness, and even suicide. None of the cases had any reported psychological or neurological problems before taking the medication.
Back in 2006 the FDA said “We are concerned that when/if the use of this drug increases in the U.S. … there may be increasing cases of adverse consequence in the U.S.”
The revised FDA warning states, “Children and teenagers with the flu may be at an increased risk of seizures, confusion, or abnormal behavior early during their illness. These events may occur shortly after beginning TAMIFLU or may occur even when flu is not treated. These events are uncommon but may result in accidental injury to the patient. Therefore, children should be observed for signs of unusual behavior and a health care provider should be contacted immediately if the patients shows any signs of unusual behavior.”
The FDA has a similar warning of the use of Relenza:
“People should be aware of the risk of increased difficulty breathing, especially among people with a history of underlying breathing problems. If patients have increased difficulty breathing, they should stop Relenxa and get medical attention right away. People with the flu, particularly children and adolescents, may be at an increased risk of seizures, confusion, or abnormal behavior early in their illness. These events may occur after beginning zanamivir or may occur when fly is not treated. These events are uncommon but may result in accidental injury to the patient. Therefore, patents should be observed for signs of unusual behavior and a health care professional should be contacted immediately if the patient shows any signs of unusual behavior.”
There are multiple cases of these “unusual behaviors”. Specifically, three people fell to their deaths after taking the drug, including a 14-year-old boy who climbed on top of the railing of his family’s condominium. The report also tells the story of an 8-year-old boy who, after taking a single dose of Tamiflu, wouldn’t answer to his own name and was growling. Another case involved a 14-year-old girl, struck with paranoia, who swore someone was watching her from outside her home and that her salad had been poisoned. The report also cites two men fell to their deaths after taking Tamiflu, and one of them left a suicide note.
Japan Bans Tamiflu in 2007
The reports came mostly from Japan because Tamiflu was prescribed far more frequently than in the U.S. (24.5 million times in 4 years in Japan, versus 6.5 million prescriptions during the same period in th U.S.). If this medication is so effective, then why in 2007 did Japan ban teenagers from using Tamiflu? Although, these psychiatric side effects are a rare occurrence, they occur nonetheless. The person in charge of banning this medication from Japan’s teens is Masato Tashiro, head of flu at Japan’s National Institute of Infectious Diseases. His reasoning for banning the flu medication was:
“My personal concern is that Tamiflu might invade the brain through the blood-brain barrier.”
When making this comment, Tashiro was speaking to New Scientist Magazine. The article says, the barrier forms a highly impenetrable layer of tissue that prevents many chemicals from crossing from the blood into the brain. In 2004, Roche (the company that makes Tamiflu) said the drug should not be given to infants under one year of age, after experiments in mice showed it depressed brain activity and caused death in animals too young to have a fully-formed barrier. Normally, Tamiflu cannot penetrate the barrier. But it becomes more permeable when the tissue is inflamed, as can happen in flu. Japanese doctors fear that Tamiflu might be getting into the brain, depressing activity and “disinhibiting” some behaviors.
The world’s next pandemic is occurring as we speak. But, if the medication that many leading countries are prescribing have modest effectiveness, and occurrences of bizarre psychiatric behavior, and a possibility of the medicine invading the blood-brain barrier, is it worth it? Are there other measures that can be suggested by our doctors? Pro-active measures need to be made. But it seems that the negatives points outweigh the positives in this case. Perhaps, before everyone gets on a “vaccination wagon” and heads to the local medical facility, try some of these suggestions:
- Boost your natural immune system with herbal teas (kombucha tea, echinachea, etc).
- Take your vitamins.
- Wash your hands frequently.
- Say home if you are sick.
- Use a tissue when sneezing or coughing.
- Maintain healthful habits — get ample sleep and exercise, drink fluids, eat well.
Tess Pennington is the author of The Prepper’s Blueprint, a comprehensive guide that uses real-life scenarios to help you prepare for any disaster. Because a crisis rarely stops with a triggering event the aftermath can spiral, having the capacity to cripple our normal ways of life. The well-rounded, multi-layered approach outlined in the Blueprint helps you make sense of a wide array of preparedness concepts through easily digestible action items and supply lists.
Tess is also the author of the highly rated Prepper’s Cookbook, which helps you to create a plan for stocking, organizing and maintaining a proper emergency food supply and includes over 300 recipes for nutritious, delicious, life-saving meals.
Visit her web site at ReadyNutrition.com for an extensive compilation of free information on preparedness, homesteading, and healthy living.
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