Archive for Thursday, October 23, 2008

Serious drug reactions reported

October 23, 2008


— The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday.

The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including more than 4,800 deaths, said an analysis of federal data by the Institute for Safe Medication Practices.

Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug's problems were prompted by tainted heparin imported from China. The other was Chantix, a new kind of anti-smoking drug from Pfizer.

Chantix, which had the most reports of any medication, works directly in a smoker's brain to ease withdrawal symptoms. It also blocks the pleasurable effects of nicotine if the patient is tempted to light up again. Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Pfizer said Wednesday it stands by Chantix, and that the volume of reports might be linked to publicity about the side effects.

"The FDA is aware of the increasing number of reports, and we take them seriously," said spokesman Christopher DiFrancesco. But officials are not sure whether reports are up because problems are getting worse, or simply due to greater awareness about drug safety issues.

The watchdog group that prepared the analysis has served hospitals and pharmacists for years as a clearinghouse for information on medication errors. Known as ISMP, the organization is now trying to reach consumers with regular reports on drug safety trends.

"We believe that one of the most important tools to promote is to monitor trends on a regular basis," said Thomas J. Moore, a senior scientist with ISMP. "Knowing which drugs are causing injuries and how many people are being hurt is the raw material we need to fashion sound measures to promote patient safety."

The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency's monitoring system relies on voluntary reports from doctors and is only believed to capture a fraction of overall problems.


Tammy Graham 9 years, 5 months ago

I have been taking Chantix for 5 1/2 weeks. It is very possible that some of the reported reactions are truly from the drug. Although, I am here to say that the withdrawal symptoms of not smoking can GREATLY alter a person's mentality whether they are taking Chantix or not. Yes, I had been grumpy and aggitated for the first three weeks of being a non smoker. I don't blame the drug, I blame the additiction to nicotine. I plan to finish my prescription and recommend it to anyone that TRULY wants to enjoy being a non smoker.

Jaylee 9 years, 5 months ago

yeah but what about this other drug mentioned and others??my dad takes blood thinner. i hope its not this one! he and my grandmother said it gave them wierd reactions. no withdrawal defense for that drug.

Tammy Graham 9 years, 5 months ago

Jaylee-You are right, no withdrawal defense for Heparin. Although, the article states that most of the reports for Heparin were linked to the TAINTED drug imported from China. I stand firm on my view of Chantix.

staff04 9 years, 5 months ago

It's unfortunate that the FDA relies first on the honesty of pharamceutical manufacturers when deciding to give clearance to certain drugs, and on independent trials second.

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