Pfizer’s Chantix Gets Grounded

“Based on this emerging information, it is no longer acceptable for controllers and pilots to be taking the drug.” – FAA spokesman Les Dorr

Air travelers have enough concerns without worrying if the pilot of their flight is taking Pfizer’s (PFE) smoking cessation drug Chantix. The Federal Aviation Administration (FAA) had approved Chantix in July 2007, four months before the Food & Drug Administration (FDA) issued a warning that Chantix can cause drowsiness, and users should exercise caution when operating machinery or driving until they know how the medication affects them. Yesterday the FAA banned use of Chantix by pilots and air-traffic controllers after the Institute for Safe Medication Practices (ISMP) released a review of additional adverse events caused by Chantix. Pilots currently taking Chantix are banned from flying for 72 hours. The FAA estimates 150 pilots and 30 air-traffic controllers could be affected.

Chantix (varenicline) is a non-nicotene tablet smokers take for 12 weeks. If they successfully quit smoking during that time, they can continue to take Chantix for an additional 12 weeks to reinforce their ability to live a smoke-free life. The FDA approved Chantix on May 11, 2006 “because of its significant potential benefit to public health.” The FDA is investigating reports of psychiatric effects, but the agency said it doesn’t have enough staff to examine the Institute’s findings.

In the fourth quarter of 2007 there were 988 serious injury reports filed, placing Chantix at the top of the list of 769 drugs examined in the US for serious side effects. (The median number of serious injury reports for other medications is 5.) Incidents included 173 traffic accidents and falls that might have been the result of confusion, dizziness, and muscle spasms; 244 potential heart rhythm disturbances, and 544 glycemic problems, including diabetes. The ISMP review is based on “adverse-event reports” which are filed with the FDA by doctors, patients, as well as plaintiff’s attorneys. Adverse-event reports do not necessarily establish a causal relationship between a drug and a side effect. However, Chantix’s warning label includes “infrequent” side effects of diabetes, vision disturbances, and cardiac arrhythmia. Balance disorders, impaired motor skills, and atrial fibrillation are considered “rare” effects.

Pfizer’s Chantix sales were $883 million within the first year of its release. Yesterday an analyst at Sanford Bernstein cut the drug’s 2012 sales forecast to $700 million from $1.6 billion. I’m not so sure Chantix will even exist by then.

Mars in Leo just conjoined Chantix’s FDA approval chart’s Saturn, reflecting action taken to limit the drug’s use. Saturn in health conscious Virgo will oppose Chantix’s Uranus in Pisces in mid-September 2008. This looks like heavy FDA action which could be as mild as a black box warning to possible withdraw of Chantix. Yesterday’s FAA ban will play a key role in any FDA decision as Uranus relates to air travel. The FAA decision occurred when the Moon (our emotional barometer) in Sagittarius was approaching conjunction with the Chantix chart Pluto. The sign Sagittarius relates to travel. Saturn in Virgo is now challenging Pfizer’s stock chart Uranus in Gemini, putting pressure on Pfizer’s stock price, which hasn’t been this low since 1997. Pluto in Capricorn is opposing Pfizer’s Sun, highlighting that Pfizer needs to completely transform its business if it hopes to remain a key big pharma player in the long term.

Addictions such as smoking, suicidal behavior, and confusion relate to the planetary energy of Neptune. Neptune’s energies are prominent now as from Earth’s vantage point, the planet will appear stationary and begin moving retrograde on May 26. Mercury in Gemini (communication and movement) will also turn retrograde that day. Mercury and its sign Gemini rule the lungs, nervous system, shoulders, arms, and hands. Many smokers will tell you they can’t kick the habit because holding a cigarette gives them something to do with their hands. Since Mercury will turn retrograde on the USA’s natal Mars, which is in a challenging alignment to the USA natal Neptune in Virgo, expect to hear a lot of information about drugs and the drug industry. Unfortunately there might also be a lot of accidents occur around this time caused by drug use.

And if you’re a smoker who wants to quit? Smokers who tried to kick the habit in the past might increase their chance of success if they stop on May 26. The Moon will be in Aquarius, the sign ruling friends and groups and will conjoin Neptune in Aquarius later that evening. (The power of friends and groups in smoking cessation is reported in today’s New York Times). The ideal time to begin a smoke-free life would be around 1:00 PM EDT, but if you’re going to stop that day, do it before 10:50 PM EDT.

No disclosures.

Related Posts: “Pfizer’s Depressing Quarter” and “Pfizer’s Artificial Ad”

New York Times: “F.A.A. Bans Antismoking Drug, Citing Side Effects”
Wall Street Journal: “Report Links Pfizer Drug To Accidents, Heart Trouble”

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