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Doctors Says FDA Ignored Chantix Worries | cialis online

Doctors Says FDA Ignored Chantix Worries

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A doctor who is an expert in smoking cessation says federal regulators ignored his concerns about Chantix when he raised them last year. Dr. John Spangler, director of Tobacco Intervention Programs at the Wake Forest University School of Medicine in Winston-Salem, N.C., says that a safety study by researchers employed by Pfizer and published in a relatively obscure medical journal looked at far too few subjects β€” a total of only 251 taking the drug β€” to determine whether or not the drug is safe when used over that duration. Yet, the researchers concluded that Chantix could be safely administered for up to one year.

Dr. Spangler also did his own analysis of the Chantix study, and told ABC News that the authors failed to mention that study subjects who took the drug were 2.5 times as likely to experience a serious adverse event – mostly heart and vision problems. Dr. Spangler said the small size of the study made it impossible to determine if the adverse events were the results of chance, or were caused by Chantix. It is Dr. Spangler’s contention that a bigger study must be conducted to determine the safety of Chantix. Until it is done, doctors who prescribed the drug must consider the possibility that an increased risk exists. Though he brought his concerns to the Food & Drug Administration (FDA) in May 2007, the FDA has not asked Pfizer to conduct such a long-term study.

In the US, 34 Chantix users have reportedly committed suicide. In February, the FDA said β€œit appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning – the agency’s highest safety alert.

Last month, the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix. The report caused the Federal Aviation Administration to ban the use of Chantix by pilots and air traffic controllers.

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