Pfizer Stands by Controversial Champix

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Mon, November 28, 2022 | 23:40

Pfizer Stands by Controversial Champix

Posted : 2009-09-09 19:36

Updated : 2009-09-09 19:36

Multinational Admits Inadequate Pre-Marketing Trials on Anti-Smoking Drug

By Bae Ji-sook
Staff Reporter

Pfizer Korea is standing by Champix, the smoking cessation drug that has reportedly caused cases of suicidal tendencies

"Until the authorities give an order to pull the drugs out we will keep Champix on the market," spokeswoman Hong Seung-won told The Korea Times.

Hong, however, admitted that the pre-marketing clinical trials were limited to a "controlled sample" of healthy people, excluding those proven to be more susceptible to the drug's side effects.

Despite a stream of reports about these, Hong insisted that no direct cause-and-effect relationship has been established.

Now, further clinical experiments on a wider sample of people are under way following an order by the U.S. Food and Drug Administration.

Hong said that it had received complaints from users but refused to reveal related statistics, citing the "confidentiality" of their private information. The drug comes in tablets and can only be purchased with a doctor's prescriptions.

Doctors say that Pfizer appears to be lacking in publicizing the side effects. A doctor said "Patients seem to know about side effects from the Internet."

The reported side effects include nausea, constipation, excessive urination, depression and suicidal impulses.

Numerous people have reportedly committed or attempted suicide while taking the drug. The United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) said last year that 10 Champix patients committed suicide and a total of 24 died.

Another 213 reported suicidal thoughts and 407 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.

In Korea, a 40-something man committed suicide while taking the drug last year. The police concluded the suicide was unrelated to the drug, but suspicions lingered among smokers trying to quit for health reasons.

The U.S. Food and Drug Administration ordered the multinational pharmaceutical company to add a black box warning inside the product package, the toughest for drugs.

The Korean drug administration also posted warnings against possible side effects. "We are keeping our eyes on it. But there hasn't been a serious case reported in Korea yet," a KFDA official said.

But many smokers say they are concerned.

"I tried to quit smoking to be healthy. Desiring to commit suicide is a huge price to pay," said Oh Suk-jin, a smoker who has tried to quit several times and was considering the use of Champix.

Austrian Smokers' Rights, a group of smokers, claimed doctors do not give their patients all the information about the drug, including the side effects, in order to help boost sales.

"It becomes frighteningly clear that most smokers are left completely in the dark by doctors and pharmacists about the serious side effects of Champix, and are only warned about the minor ones. The fact that this negligence is leading to injuries and deaths must surely be actionable."

In 2008, Pfizer financed online, television and print commercials for the Korean Medical Association's "Quit Smoking" campaign without mentioning its name in the ads.

bjs@koreatimes.co.kr

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