Posted : 2009-10-13 18:33
Updated : 2009-10-13 18:33

Pfizer Slow in Addressing Champix Side Effects

By Bae Ji-sook
Staff Reporter

Pfizer Korea has not been forthcoming in the face of requests for clarification over the side effects said to result from the use of its smoking cessation product Champix, The Korea Times has found.

Coming clean on the side effects from the purported nicotine addiction buster ― based on the drug varenicline ― in a prompt manner is seen as important because it is a top-selling anti-smoking drug on which a growing number of Koreans rely.

Champix is a prescription-only drug that has attracted many lawsuits amid reports of a wide-range of side effects worldwide, triggering the U.S. Food and Drug Administration to include it on its list of drugs for a “Black Box” alert, the highest warning level. It has been marketed since 2007 in Korea and is highly popular.

Though The Korea Times has requested a meeting and an interview twice in order to ascertain clarification, Pfizer Korea has refused. “We have reported all side effects here to the Korea Food and Drug Administration,” its spokeswoman Lee Eun-jeong said. But she refused to reveal what they were.

Though Champix is promoted and acknowledged for its eminent effect in eliminating the desire to smoke, Pfizer is facing over 200 lawsuits in the U.S.

The U.S. government banned the product for use among pilots and air traffic controllers, as well as commercial drivers, amid concerns over neuropsychiatric symptoms. Champix, distributed as Chantix in the U.S., experienced a 49-percent drop in sales in 2008 as a result.

The Institute for Safe Medication Practices, a U.S.-based nonprofit public health advocate, said 1,001 serious incidents involving Chantix users were reported in the first quarter of that year.

The Medicines and Healthcare Products Regulatory Agency (MHRA), a U.K. government body, said last year that 10 Champix patients committed suicide among a total of 24 who died.

An additional 213 users reported suicidal thoughts and 407 others said they became depressed while taking the drug. The MHRA said that the number of reported adverse incidents from Champix almost doubled to 3,541 in September from 1,811 in February.

Kristian Rasmussen, attorney with the law firm Cory Watson Crowder & DeGaris, working for a widow whose husband allegedly shot himself after taking the drug, was quoted as saying, “This man’s death was a direct result of taking the drug Chantix.” Dr. Daniel Seidman, professor of Medical Psychology at the Columbia University College of Physicians and Surgeons said in an interview with other papers that “When Chantix goes wrong, it can go terribly wrong.”

He said in a written interview with The Korea Times that 12-month results of taking the drug were not better than nicotine replacement. The nicotine replacement is vastly safer than smoking.

“It was my analysis of the original studies which excluded smokers with psychiatric, alcohol and many medical problems. So it was marketed to a group excluded from the FDA studies,” he said.

Song Mi-ok of the Korean Pharmacists for Democratic Society, a civic group, said not a single doctor in Korea will stand against the world’s largest pharmaceutical firm because of their own interests. She said her civic group is tracking the drug, but still has long way to go.

In fact, reports from the Korea Medical Association, a doctors’ lobby group, do not mention any risk, while praising its smoking cessation results.

In its clinical tests in Korea, Champix was shown to cause cases of nausea, insomnia and nightmares. Some users complained about depression, anxiety, change in attitude and suicidal impulses.

In 2007, a man in his 60s killed himself after using the drug for a month, although the direct links between the use and the suicide have not been established.

However, the actual number or outcome of the side effects could be much higher since Korean law does not subject doctors and drug-takers to report side effects immediately. “While people in the U.S. or other countries make sincere reports, Koreans tend to ignore it or tone it down,” a KFDA official said.

The drug, which was distributed here in 2007, is under a seven-year monitoring program.
The authorities have refused to disclose the exact data of the reported side effects during the period. “We cannot jump to a conclusion that Champix alone is responsible for such symptoms,” the KFDA official added.

The authorities have, however, issued warnings against the drug twice, when the American authorities upgraded their warning and decided to conduct a thorough investigation of it. “If any major incident happens, we will inform the people,” the official said.
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