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CYA TMI? Drug Label Warnings List Dizzying Number Of Adverse Events

Drug labels warn about a mean of 70 adverse events per medication, leading researchers to conclude that the glut of information is confusing patients.

Jon Duke, MD, an ACP Member, and other researchers extracted 534,125 adverse drug events from 5,602 product labels. There was a mean of nearly 70 events per label. They found 588 with more than 150 adverse drug events and 84 with more than 300, with the top offender having 525 events listed. This top group included selective serotonin reuptake inhibitors, anti-virals, and restless leg syndrome drugs.

Labels for the 200 most commonly dispensed medications contained significantly more adverse drug events than others (median, 79 vs. 47; P<.001). By specialty, there were more adverse drug events listed in the fields of neurology (n=168), psychiatry (n=116), and rheumatology (n=111).

Drugs approved during the 1980s and 1990s had the highest overall number of adverse drug events, while newer medications had significantly more labeled adverse drug events than older medications.

“The findings aren’t unexpected,” wrote Dr. Duke and colleagues in the Archives of Internal Medicine. Newer drugs face more rigorous clinical trials and postmarketing surveillance than older medications. More commonly prescribed drugs are more likely to generate more reports of adverse events. The high volume of events in neuropsychiatric medications “may relate as much to patient population as to the effects of the drugs themselves.”

But, Dr. Duke and colleagues concluded, “The presence of such excess data still may induce information overload and reduce physician comprehension of important safety warnings.”

While the Food and Drug Administration tried to revamp warning labels in 2006, labels have grown more complex since then. “This finding underscores the tremendous challenge faced by the FDA in reversing the long-standing trend toward overwarning.”

*This blog post was originally published at ACP Internist*

Legal Battles Over Chantix: The Next Great Get-Rich-Quick Scheme For Smokers

Chantix lawsuits here we come.  I’ve been prescribing Chantix and helping fill out forms for free Chantix for my patients for several years now.  Chantix is one medicine used to help get patients to quit smoking right now.  In fact, I even had a case presentation of a woman I warned to quit smoking for good or face a lifetime of being cross eyed.

Does Chantix help to quit smoking? Yes it does.  It helps to take the cravings away in folks who use it.  If you smoke, you should want to quit, based on my discussions with a tobacco farming insider.  If nothing has helped, Chantix might be your last hope.  As a hospitalist, I always offer Chantix therapy as part of my smoking lecture (that I bill out as smoking cessation CPT 99406 or 99407)
With the average cost of cigarettes going through the roof, the percentage of Americans who smoke has come down.  For those still hanging on, taking Chantix to help quit seems like a perfect opportunity to put down the cancer sticks forever.  Until the nicotine vaccine becomes widely available I just don’t think we have that many other options available.

But now it seems like Chantix lawsuits may be the next greatest get rich scheme for smokers every where.  On May 19th, 2011 the FDA responded to a report from the QuarterWatch: 2010 Quarter 3  Institute of Safe Medication Practices report regarding the safety profile of Chantix .  You can view the Chantix information on this pdf file starting on page 14.     Pfizer sent the FDA information  on several thousand  Chantix adverse  drug events (ADEs) resubmitted to the FDA’a Adverse Events Reporting System in July 2010 at the FDA’s  request.  These events reportedly had been previously submitted in a form that did not allow for a comprehensive evaluation.

These included 150 completed suicides dating back to 2007 along with hundreds of incidents of psychosis, depression and attempted suicide.    In the third quarter of 2010, varenicline had  1,055 serious adverse drug events reported, more than any other drug the ISMP montitors and Chantix ranked first with twice as many deaths reported related to Chantix exposure.

Pfizer said they were unable to repond to the findings of the ISMP because of their possible involvement in future legal cases.  Here is the FDA response statement to the ISMP QuarterWatch report:

In 2006, the Pfizer product, Chantix (varenicline), was FDA-approved as a smoking cessation aid. Soon after marketing, FDA became aware through its postmarketing surveillance system, the Adverse Events Reporting System or AERS, of the potential for serious neuropsychiatric events in patients taking Chantix. Subsequently, FDA began communicating about these potential risks with health professionals and patients. A list of previous safety communications can be found on the Chantix Information page.

Amid continuing adverse event reports, in July 2009, the FDA required that Pfizer update the Chantix label with the most restrictive safety labeling – a boxed warning – describing the risk for neuropsychiatric events. This warning was directly related to the association of Chantix with suicidal thoughts and aggressive behavior. In addition, in 2008, FDA required a mandatory medication guide for patients describing this risk.

In July 2010, Pfizer, at the request of FDA, resubmitted a large number of adverse event reports that were initially sent to the Agency in a way that did not allow for comprehensive evaluation. Although this resubmission included thousands of reports of potential adverse events, these events were spread out over a number of years, and had been reported to the agency periodically in summary safety reports. These reports confirm what we already knew about Chantix and would not have changed the Agency’s position on the drug’s risks and benefits, given that the data in these reports were consistent with those that led to the 2009 labeling change. At this point, based on the data, FDA does not have any new safety concerns with Chantix, though those that have been established remain under active review.
The Agency takes seriously the adverse events associated with all drugs, including Chantix. FDA continues to monitor for serious and unexpected events associated with Chantix. FDA has initiated additional postmarket safety activities. Specifically, it has required the manufacturer of Chantix to conduct a large, comparative, postmarket clinical trial assessing the safety of Chantix among other smoking cessation aids. FDA has also initiated two observational safety studies on Chantix, one with the Veterans Administration and one with the Department of Defense.

Last year, FDA became aware that a few manufacturers were submitting adverse events reports to FDA through improper channels. At that time, FDA clarified its instructions to drug manufacturers, including Pfizer, to submit adverse event reports through a channel that would allow for the adverse event reports to be entered into FDA’s Adverse Event Reporting System, a database of postmarketing adverse event reports that allows for review by the Agency’s safety staff. These instructions were clarified and put on the FDA website for AERS Electronic Submissions2.

FDA will continue to monitor the postmarket safety of Chantix and will communicate any new information as it becomes available. The Agency remains committed to monitoring the safety of drugs as they are used in the postmarket, real-world setting.

Chantix lawsuits, here we come. I think all hospitalists should be aware of these significant findings.  Should we stop prescribing the drug?  I think I’m done with it.  I’d rather have my patients die a slow and painful death filled with morbid disability spread over many years than to have one claim I tried to knock them off with a little  bloodless surgery.

Pick your poison, I guess. There’s always cold turkey available too.

*This blog post was originally published at The Happy Hospitalist*

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