When Thomas J. Moore analyzed data collected from the FDA’s Adverse Events Reporting System (AERS), he found nearly 600 reports of serious adverse reactions, including 150 suicides, were mixed in with 26,000 records of non-serious side effects such as nausea and skin irritations. These “missing” reports, some of which go back to 2006, also include accounts of uncharacteristic aggression and hostility, violent outbursts, severe nightmares, and debilitating depression.

In an interview with MSNBC, Mr. Moore said the situation represents “a major breakdown in safety surveillance.”

Chantix has long been blamed for causing severe psychosomatic distress in people who use the drug to ease the cravings for cigarettes while trying to quit smoking. Even before the additional reports of hostilities and suicides were discovered, Chantix has topped the list of the most dangerous FDA-approved drugs.

“It’s really chilling,” Moore added. “This seems to unleash something in people. It can be violence to anything around.”

Until July 2010, the FDA received 122 reports of suicide linked to Chantix, less than the number of suicides contained in the newly discovered reports. Mr. Moore also found the 589 concealed included 102 cases of hostility and aggression, 156 cases of depression, and 56 cases of possible psychosis.

Although Pfizer willfully included these reports with those of less serious side effects, technically the pharmaceutical giant wasn’t breaking the law. The FDA’s reporting system contains two channels through which adverse reactions are reported by drug companies. The “expedited” channel is for serious and unexpected injuries that drug makers must report within 15 days. The other “periodic” channel is for less-serious and expected adverse reactions, which drug companies must report quarterly.

Believe it or not, the FDA does not require companies to submit new reports of death and serious injury in the “expedited” channel for urgent review when such adverse events are already known to exist. This provision allowed Pfizer to include the suicides, suicide attempts, depression, and violent outbursts in with the less-serious, expected adverse events where they went overlooked.

The reported serious side effects were further obscured when Pfizer combined summaries and individual case reports into a s single text file instead of logging them into the AERS system individually, which dramatically reduced the occurrence of serious side effects linked to the drug.

Just as outrageously, the FDA seems to recognize the flaws in its reporting requirements, but isn’t in a rush to fix them. According to MSNBC, “FDA officials said they are considering changing regulations to allow expedited reports of suicides and other serious problems, even if they’ve previously been identified as expected. First proposed in 2003, that change is still pending.”

U.S. doctors prescribed Chantix 3.2 million times last year to smokers trying to kick the habit. The drug has been prescribed 1.1 million times so far this year.

Source:
http://www.msnbc.msn.com/id/43187290/ns/health-health_care/

SOURCE: Chantix Recall › Chantix suicides and violence much more common, newly found reports show

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

The decision to turn the volume up on Chantix warnings follows several months of reports linking the drug to a slew of negative side effects. Feeling unusually agitated, depressed, or hostile are some of the effects commonly reported. Sudden changes in behavior, impulsive or disturbing thoughts, and the desire to hurt oneself or others are some of the more serious reactions reported.

In the United States, the Food and Drug Administration received more reports of serious injuries arising from Chantix than for any other drug. Prescription drug related death, which normally accounts for 16 percent of all serious reactions reported to the FDA, soared to 23 percent in the first quarter of 2008, largely because of Chantix. The U.S. has since strengthened warnings on Chantix labels.

Health Canada says that while Chantix can be an effective aide in quitting smoking, users of the drug and their families should closely monitor behavior for any changes. Sudden shifts in mood, depression, aggression, and thoughts of self harm are red flags that everyone should watch for. The person taking Chantix should avoid driving and operating heavy machinery until they know that Chantix does not have any adverse effects on them, Health Canada recommended.

Pfizer’s spokesman in Canada, Christian Marcoux, said that Chantix is safe and that some of the adverse side effects are actually caused by quitting smoking.

SOURCE: Chantix Recall › Canada strengthens Chantix warnings

The dramatic increase of pharmaceutical drug related injuries occurred in the first three months of 2008, during which time 20,745 serious side effects and more than 4,800 deaths were reported. The incidents represent a 38 percent rise over the previous four quarters and constitute the single highest spike yet recorded.

Prescription drug related death historically accounts for 16 percent of all serious cases reported. That number soared to 23 percent in the first quarter of 2008.

According to the FDA standards, a serious drug reaction is one that leads to medical intervention or hospitalization and jeopardizes the life of the user. AERS data comes from reports that are voluntarily submitted by medical professionals. The data is generally regarded as a small representation of a much larger picture.

According to ISMP, “Some of the increases in quarterly totals could represent normal variation in the flow of reports rather than signaling a long-term trend in patient safety. However, the data are compelling and should serve as one source of information regarding drug safety in the US.”

More reported serious injuries result from Chantix usage than any other prescription drug. Chantix accounted for 1,001 new cases of serious injury, including 50 deaths.

Pfizer refuted the FDA data and ISMP’s interpretation of it. “Based on [the] totality of data, we stand by the efficacy and safety profile of Chantix when used as directed,” said Pfizer spokeswoman Kristen Neese in a statement.

SOURCE: Chantix Recall › Chantix plays role in record number of drug reactions