Data pulled from the FDA’s Adverse Event Reporting System (AERS) between October and December of 2008 suggested that Chantix may be linked to the side effects. The FDA will continue to monitor Chantix for an unspecified length of time until it determines what, if any, regulatory action is needed.

The FDA does not fully test prescription drugs for safety before allowing them to enter into the market. Why? It’s a matter of logistics more than anything. Typically, FDA studies are designed to measure a drug’s effectiveness using thousands of patients who willingly participate in pre-market clinical trials. These patients obviously represent a very small slice of U.S. population. The FDA also relies on studies conducted by the pharmaceutical companies themselves to determine how effective test drugs are. If new drugs that have passed tests for efficacy appear to be reasonably safe, then FDA researchers give them the green light.

The FDA, incidentally, reviewed Chantix in six months rather than the regular review time of 10 months.

The millions of people in the U.S. and around the world who started taking Chantix when it debuted on the world market in May 2006 became patients in the world’s first mass clinical trial. Most people assume that the FDA seal of approval means that the drug will be perfectly safe, but the truth is that most of a drug’s risks are not known until it is prescribed to millions of consumers.

The first reports of adverse events linked to Chantix emerged just months after the drug was released to the public. On February 1, 2008, the FDA issued a statement saying “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.”

By May 2008, Chantix was linked to more than 3,000 reports of serious side effects. By November of the same year, data from the FDA’s Adverse Event Reporting System showed that more reported serious injuries resulted from Chantix than any other prescription drug.

SOURCE: Chantix Recall › FDA monitoring Chantix for serious risks, new safety concerns

Chantix, manufactured by Pfizer, was approved in 2006 and since that time has been prescribed to more than 4 million patients. However, not long after its release, the drug was linked to psychiatric problems including depression, suicidal thoughts and actions, and aggressive behavior. The drug also has been linked to serious physical side effects including heart problems, diabetes and serious allergic reactions such as Stevens Johnson Syndrome.

According to the Stars & Stripes, the drug was removed from the military pharmacy at Yokota Air Base in Japan. The decision came after a May 21 report by the Institute for Safe Medication Practices, which says Chantix has had more serious adverse incident reports in the fourth quarter of 2008 than any other drug in this time period.

In response to the ISMP report, the Federal Aviation Administration banned pilots and air traffic controllers from using the drug. The Stars & Stripes reports that the Defense Department’s Office of the Chief Medical Officer also recommended that “varenicline should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members.”

The paper says the DOD safety notice also had recommendations for “vehicle operators, operational personnel, and other DOD personnel” under consideration.

Stars & Stripes says the Yokota base has not reported any adverse reactions to Chantix, but seems to be banning the drug as a precautionary measure, and has suspended refills of Chantix until patients review the drug use with their physician. Other base hospitals overseas have not banned the drug, but air crewmembers cannot take the drug, and other Chantix patients are required to discuss their use of the product with their physician. Pharmacies can special-order the drug based on those prescriptions.

According to the report, when Chantix was first licensed in 2006, it was prescribed 262 times in military treatment facilities. By fiscal year 2007, there were 67,580 prescriptions written for Chantix in military facilities.

SOURCE: Chantix Recall › Military pharmacy pulls Chantix

“Those in the VA who failed to properly notify America’s veterans that their medication could produce fatal side effects must resign their positions,” Lisicki said. “If not, then the VA secretary must take decisive action to terminate their employment.”

Lisicki issued the off-with-their-heads statement in response to reports (link) that the VA may have acted irresponsibly in its study of Chantix using veterans with Post Traumatic Stress Disorder (PTSD).

The VA originally said that 940 veterans with PTSD were enrolled in the study, but only 143 of them were receiving Chantix. (link) However, The Washington Times revealed the number of PTSD veterans receiving Chantix was actually 68 percent higher than the VA originally acknowledged: 241, as opposed to 143.

Of the 241 test subjects, there were 114 reported adverse effects, including 22 psychiatric events.

The VA also prescribed Chantix to some 32,000 other veterans. From that group, 27 were admitted to VA hospitals for apparent psychiatric disorders. Among those, 11 had attempted suicide, 9 had suicidal thoughts, six suffered from hallucinations, and 1 attempted homicide.

Last month, ABC News and The Washington Times revealed (link) the VA’s failure to notify the study’s veterans about the potential psychiatric hazards of Chantix until three months after the FDA’s initial warnings.

Secretary of Veterans Affairs James B. Peake, M.D. insists that the VA has nothing but the veterans’ best interests in mind in determining courses of treatment. After the joint ABC News / Washington Times broke, allegations emerged implying that big pharmaceutical companies and universities may be funding and compromising VA research and care. Dr. Peake called the allegations “ridiculous.”

Still, Dr. Peake has ordered four internal investigations of the Chantix study and the VA’s general operations, ostensibly to safeguard against repeating similar blunders in the future.

To Lisicki and many veterans, the VA’s neglect in informing PTSD veterans about the dangers of Chantix, followed by the administration’s unapologetic attitude, is inexcusable.

“Professional ethics and common sense just dictate that clinicians would stop their patients from taking the drug just to err on the side of safety for the veterans and their families,” Lisicki said.

If the VA tests Chantix on veterans with PTSD, then how would it be able to determine if the emotional and behavioral problems are caused by the drug or the psychological trauma? Wouldn’t being able to differentiate between two possible causes determine the best course of treatment?

Aren’t our veterans worthy of an administration that treats them with genuine care and, perhaps above all, compassion?

SOURCE: Chantix Recall › More veterans enrolled in Chantix study than originally revealed

Factoring into the decision was the fact that Smith did not have any prior record of criminal activity or psychiatric disorders, the AP report says.

This incident is the latest in a crop of reports that Chantix is responsible for serious psychiatric problems, including depression, suicidal thoughts, suicide, and aggressive behavior. On Feb. 1, the FDA issued a public advisory about the possibility for these adverse serious side effects.

SOURCE: Chantix Recall › Charge dropped due to Chantix use

As a result of these reports, the FDA issued a public advisory, and required new safety warnings on the label. However, the FDA said it is still not sure if the side effects are attributable to Chantix, or may stem from nicotine withdrawal itself, which may worsen underlying existing psychiatric symptoms.

The Star-Ledger report says the FDA was spurred to more closely examine Chantix after a case in Dallas, Texas, involving musician Carter Albrecht, who was fatally shot after a night of “uncharacteristically violent behavior,” which his family attributed to his Chantix use.

According to the Star-Ledger, Pfizer said there were no suicides attributed to the drug during clinical trials, and they did not note any differences in behavior in clinical test subjects. However, the company also says that no people with known existing psychiatric disorders were used in the trials.

The drug is currently undergoing further study.

SOURCE: Chantix Recall › Dark side of Chantix comes to light