I hate to generalize about the media always seeming to sensationalize and report much more of the bad then good, but the latest flurry of Chantix news does not help to broaden my opinion. Despite some excellent news recently about the Pfizer's smoking cessation drug Chantix (more on this below), the headlines suggest otherwise, such as
More Trouble for Pfizer’s Smoking Cessation Drug Chantix from the WSJ and Forbes'
Pfizer's Chantix Going Up In Smoke.
This wave of "news" stems from recent reports that first the FAA banned pilots and air traffic controls from using Chantix, and subsequently The Federal Motor Carrier Safety Administration that oversees trucks and buses issued a warning that they would not qualify anyone currently using Chantix for commercial motor vehicle licenses. Both agencies based their decision from a report released from the non-profit
Institute for Safe Medication Practices that examined adverse-event reports turned into the FDA and found 988 serious health problems reported in association with Chantix use, including seizures and heart trouble.
It is important to note that the ISMP is not a federal or regulatory agency, and it is not the FDA. The FDA reviewed these reports, and despite
their eagerness to get out any bad news about medications, didn't seemed to concerned. This is because when millions of people start taking a drug, some people are going to have side effects. The side effects reported are rare and are consistent with side effects found in the studies that Pfizer submitted to the FDA.
However, looking at post-marketing side effects is very important. Chantix is a good example. As I
blogged about previously, in the studies that the Pfizer submitted to the FDA, Chantix had few interactions and side effects (except nausea, which was usually mild and usually went away). However, because Chantix compared its drug to bupropion (the only other pill indicated for smoking cessation, but also used for depression), patients with mental illness were excluded from the study. What happened was that once the drug hit the market, and started to be taken by patients with mental illness, some patients and doctors observed worsening of their mental conditions, including suicide. This does not necessarily mean that this was caused be Chantix, because just stopping smoking can cause these effects. However, the FDA appropriately released an
early warning back in November of 2007.
Do not get this warning confused with the recent news about the FAA and FMCSA. They are not related. The former is a warning from the FDA about newly discovered side effects and the later is an agency decision based on information from a non-profit regarding issues that the FDA knew about and didn't seemed too concerned.
Adverse event reporting is important, and it seems like the FDA is finally going to
ramp of the process of reporting, which is currently voluntary and quite spotty.
However, in all the recent media storm about Chantix, very recent good news was lost. Hear are the headlines you didn't read.
New Smoking Cessation Guidelines find Chantix the Most Effective Pill to Help Smokers Quit Earlier this month, the surgeon general released "
Treating Tobacco Use and Dependence: 2008 Update" which is the latest smoking cessation guideline. The guideline builds on the previous document from 2000 showing that there are multiple therapies, including medications that are effective at helping smokers quit. In fact, medication (pills, patches, gum, etc. ) are so effective, the guidelines recommend these for EVERY smoker. Since Chantix was new, they looked at the data around Chantix. There is a
table which shows the relative effectiveness of medications, and Chantix rose to the top. Tobacco smoke is the single leading preventable cause of death in the US. Guidelines clearly state that medications should be offered to all smokers who want to quit. Chantix is the most effective agent. That sounds like good news to me.
FDA Label Change to Chantix Reassuring As mentioned above, the FDA looked into the issue of worsening of neuropsychiatric symptoms in patients taking Chantix. On May 19th, the FDA made the final update to the
Chantix label, which was the following:
"Advise patients and caregivers that the patient should stop taking CHANTIX and contact their health care provider immediately if agitation, depressed mood, or changes in behavior that are not typical for them are observed, or if the patient develops suicidal ideation or suicidal behavior." If you read between the lines, this is an appropriate warning, and not a serious precaution such as the dreaded "black box" warning. The label doesn't say that Chantix even causes these side effects (because they may not) but doctors and patients, especially those with mental health disorders should look out for these symptoms. This should be reassuring to patients and providers that they can use Chantix without concern, as long as they take this observation into account.
Why is it that we don't see these headlines in the media? The result is unnecessary worry and fear by doctors and patients.
This wave of "news" stems from recent reports that first the FAA banned pilots and air traffic controls from using Chantix, and subsequently The Federal Motor Carrier Safety Administration that oversees trucks and buses issued a warning that they would not qualify anyone currently using Chantix for commercial motor vehicle licenses. Both agencies based their decision from a report released from the non-profit Institute for Safe Medication Practices that examined adverse-event reports turned into the FDA and found 988 serious health problems reported in association with Chantix use, including seizures and heart trouble.
It is important to note that the ISMP is not a federal or regulatory agency, and it is not the FDA. The FDA reviewed these reports, and despite their eagerness to get out any bad news about medications, didn't seemed to concerned. This is because when millions of people start taking a drug, some people are going to have side effects. The side effects reported are rare and are consistent with side effects found in the studies that Pfizer submitted to the FDA.
However, looking at post-marketing side effects is very important. Chantix is a good example. As I blogged about previously, in the studies that the Pfizer submitted to the FDA, Chantix had few interactions and side effects (except nausea, which was usually mild and usually went away). However, because Chantix compared its drug to bupropion (the only other pill indicated for smoking cessation, but also used for depression), patients with mental illness were excluded from the study. What happened was that once the drug hit the market, and started to be taken by patients with mental illness, some patients and doctors observed worsening of their mental conditions, including suicide. This does not necessarily mean that this was caused be Chantix, because just stopping smoking can cause these effects. However, the FDA appropriately released an early warning back in November of 2007.
Do not get this warning confused with the recent news about the FAA and FMCSA. They are not related. The former is a warning from the FDA about newly discovered side effects and the later is an agency decision based on information from a non-profit regarding issues that the FDA knew about and didn't seemed too concerned.
Adverse event reporting is important, and it seems like the FDA is finally going to ramp of the process of reporting, which is currently voluntary and quite spotty.
However, in all the recent media storm about Chantix, very recent good news was lost. Hear are the headlines you didn't read.
New Smoking Cessation Guidelines find Chantix the Most Effective Pill to Help Smokers Quit
Earlier this month, the surgeon general released " Treating Tobacco Use and Dependence: 2008 Update" which is the latest smoking cessation guideline. The guideline builds on the previous document from 2000 showing that there are multiple therapies, including medications that are effective at helping smokers quit. In fact, medication (pills, patches, gum, etc. ) are so effective, the guidelines recommend these for EVERY smoker. Since Chantix was new, they looked at the data around Chantix. There is a table which shows the relative effectiveness of medications, and Chantix rose to the top. Tobacco smoke is the single leading preventable cause of death in the US. Guidelines clearly state that medications should be offered to all smokers who want to quit. Chantix is the most effective agent. That sounds like good news to me.
FDA Label Change to Chantix Reassuring
As mentioned above, the FDA looked into the issue of worsening of neuropsychiatric symptoms in patients taking Chantix. On May 19th, the FDA made the final update to the Chantix label, which was the following:
"Advise patients and caregivers that the patient should stop taking CHANTIX and contact their health care provider immediately if agitation, depressed mood, or changes in behavior that are not typical for them are observed, or if the patient develops suicidal ideation or suicidal behavior."
If you read between the lines, this is an appropriate warning, and not a serious precaution such as the dreaded "black box" warning. The label doesn't say that Chantix even causes these side effects (because they may not) but doctors and patients, especially those with mental health disorders should look out for these symptoms. This should be reassuring to patients and providers that they can use Chantix without concern, as long as they take this observation into account.
Why is it that we don't see these headlines in the media? The result is unnecessary worry and fear by doctors and patients.