Suits allege harm from Pfizer quit-smoking drug

NEW YORK, Jan 14 (Reuters) – Three personal injury lawsuits were filed against Pfizer Inc (PFE.N) on Thursday, claiming its smoking-cessation drug Chantix caused attempted suicides or death.

The suits, all filed in New York State Supreme Court in Manhattan by the same plaintiffs’ law firm, claim Pfizer failed to notify doctors and patients about dangers the company allegedly knew about the pill — including depression and suicidal thoughts–at the time the plaintiffs took the medicine.

And even though Pfizer subsequently added warnings to its package insert, the law firm alleged the drug label is still inadequate.

Pfizer introduced Chantix in the United States in 2006, with hopes it would become a huge product that would help revive flagging company profits, but its sales have wilted amid concern about side effects.

“Defendant intentionally, recklessly, and/or negligently concealed, suppressed, omitted, and/or misrepresented the risks, dangers, defects and disadvantages of Chantix,” attorney Marc Grossman alleged in all three lawsuits.

Grossman is with the Mineola, New York law firm of Sanders Viener Grossman LLP.

Pfizer could not immediately be reached for comment. (Reporting by Ransdell Pierson and Bill Berkrot; editing by Carol Bishopric)

Chantix and Champix, which are both manufactured by Pfizer, Inc., contain the pharmaceutical ingredient varenicline tartrate, which blocks brain receptors that are normally stimulated by nicotine. The drug is designed to lessen the pleasure effects of nicotine and help users quit smoking.

In the United States, Chantix has been associated with a number of serious and potentially life-threatening side effects, including an increased risk of suicide, suicide attempts and unusual behavior. A number of users have also report developing new-onset diabetes after taking the drug and suffering seizures and blackouts, which could result in serious accidents or injury.

According to the Journal article:

The Institute for Safe Medication Practices said 1,001 serious incidents involving Chantix users were reported in the first quarter of this year, based on its analysis of government safety data. That is more than the total number of serious incidents for the top 10 most-prescribed brand-name drugs combined.

Chantix already has been linked to serious psychiatric side effects such as depression and suicidal behavior. In 2007 Pfizer strengthened the warning label. The company has said that nicotine withdrawal itself “can cause changes in behavior, such as irritability and depressed mood.”

This Spring, the FDA issued a warning guide for doctors perscribing Chantix.

Chantix, which had $883 million in total 2007 sales, has experienced a steep decline. Its third-quarter sales in the U.S. fell 49% from last year’s third quarter, dropping to $96 million from $186 million. This summer, Pfizer took out full-page ads in major newspapers defending the drug and noting the severe risks to health from smoking.

According to Forbes:

The study, called APPROACH, used a technique called intravascular ultrasound (IVUS) to measure how thickly plaque built up in the heart arteries among patients taking either Avandia or Glucotrol, a different type of diabetes drug. The results were presented at the annual meeting of the American Heart Association in New Orleans.

The IVUS technique was pioneered by Steven E. Nissen, the same Cleveland Clinic cardiologist who put Avandia’s cardiovascular risk in the spotlight. Last March, he presented a study of Avandia’s main rival, Actos from Takeda, that showed that the drug significantly decreased the amount of plaque in coronary arteries.

Glaxo said in a release that the APPROACH results show that Avandia is similar to Actos. APPROACH enrolled 672 patients and obtained artery images for 462 of them.

James Stein, an expert in cardiovascular imaging technologies at the University of Wisconsin, says “given the possibility that Avandia does cause heart problems, physicians and patients should consider other diabetes pills.”

“There’s really no reason anybody should be using Avandia,” says Stein. “It’s time to give this drug a rest. There are better, safer alternatives.”

GlaxoSmithKline (nyse: GSK) has steadfastly defended Avandia’s cardiovascular safety. Nesto co-authored an analysis of existing trial data saying that there is no risk for the drug.