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Last Updated: Dec 27th, 2006 - 19:07:47 |
After reviewing the safety reports for Oseltamivir (Tamiflu), a United States Food and Drug Administration (FDA) advisory committee concluded Nov. 18 that there was no evidence linking the deaths of 12 children aged one to 16 in Japan to the antiflu drug.
Roche, the maker of Tamiflu, hailed the ruling. "The positive role of Tamiflu remains unchanged," said William M. Burns, CEO Roche Pharma Division.
The 12 deaths, which all occurred after the year 2000 include one suicide, four sudden deaths, four cardiac arrest and three pneumonia, asphyxiation and acute pancreatitis, according to BBC News.
The Health Ministry of Japan warned last week that Tamiflu might induce strange behavior after these deaths, particularly the deaths of two teenage boys shortly after taking the drug.
The FDA conducted the review on the safety of Roche’s Tamiflu along with seven other drugs, as required by Section 17 of the Best Pharmaceuticals for Children Act (BPCA). "BPCA mandates the review of the adverse event reports received during the one-year after a drug has been granted pediatric exclusivity," the FDA said.
The review discussed pediatric deaths, serious skin disorders, and neuropsychiatric events. The events were reported almost entirely in children from Japan. Of 32 million people treated with Oseltamivir or Tamiflu since its approval in 1999, 24 million including 11.6 million children were in Japan, according to Roche.
Tamiflu is regarded as the best available antiviral drug for preventing and/or treating human avian flu. Many countries have rushed to make and stockpile the medication, fearing the strain H5N1 may soon evolve into a variant that can spread the disease from one person to another, causing a pandemic.
Dr. Robert Nelson, chair of the FDA's Pediatrics Advisory Committee, was quoted by The Associated Press (AP) as saying, "if we ever have a pandemic of avian flu, which is a debatable point, people want to know that they have a drug that will not cause more harm than the flu itself. There is no evidence that this will."
The FDA said on its Web site that the deaths were caused by influenza-related encephal itis and encep halopathy, which commonly affected Japanese children since the mid-1990s before Oseltamivir or Tamiflu was approved. It said there was no evidence suggesting a causal relationship between Tamiflu and the deaths.
The committee identified that nearly all 12 children suffered neurologic and psychiatric problems such as delirium, hallucinations, abnormal behavior, convulsions, and encephalitis. The FDA acknowledged, "In many of these cases, a relationship to Tamiflu was difficulty to assess because of the use of other medications, presence of other medical conditions, and/or lack adequate detail in the reports."
"These reports originated primarily from Japan where pediatricians described a pattern of rapid onset of fever, accompanied by convulsion and altered level of consciousness, progressing to coma within a few days of the onset of f lu symptoms,” the FDA said. “This syndrome frequently resulted in death or significant neurologic sequelsae."
These reports prompted Japan to launch a nationwide surveillance. This happened before Tamiflu was approved, the FDA said.
"The increased reports of neuro psychiatric events in Japanese children are most likely related to an increased awareness of influenza-associated ence phalopathy, increased assess to Tamiflu in that population, and a coincident period of intensive monitoring adverse events," the statement said.
Use of Tamiflu does not increase neuropsychitric events, which can occur often with flu patients, Roche said. Beginning in the mid-1990s, many reports have described a syndrome of flu-associated encepha litis (inflammation of the brain) or encephal opathy.
Roche said in a statement "Mortality in patients taking Tamiflu, both in adults and children, is lower than in influenza patients who are not treated with Tamiflu. Based on independent studies, death rates in children treated with Tamiflu are reduced between 60 to 90 percent"
The FDA said the review also identified severe skin reactions (like allergic reactions) in some pediatric patients. These side-effects were not all reported in Japanese children and have also been reported in adults. Severe skin disorders in all age groups are currently being reviewed in more detail, the AP reported.
The committee asked the FDA to give an update about in a year on adverse events related to taking Oseltamivir or Tamiflu and provide a full report in two years. It did not recommend any warning for Tamiflu other than adding information about severe skin responses to the label, according to the AP.
Roche said it would "work with the FDA to change the drug's labeling based on adverse skin events that have occurred in a small number of patients, mostly in Japan".
The FDA anticipated continuing the monitoring of the adverse events of Tamiflu, including neuropsych iatric adverse events, and said they would report back to the committee within two years.
"We welcome the outcome of the FDA advisory committee and look forward to working with the FDA and other health authorities to extend our knowledge of the use of Tamiflu and its safety profile," said Williams Burns, chief of Roche 's Pharma Division.
For more information, visit tamiflu.com and FDA Tamiflu info pages
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