Users who purchased the drug Champix, which is used as part of a smoking cessation program, received a message today (Wednesday) from the health funds that they must return the product to the pharmacy. This, after in several packs of the product in the company’s factories, excess amounts of the substance nitrosamine were discovered.
Nitrosamine is a substance found in small amounts in food and water products. It has been previously found that with prolonged exposure to very large amounts of it, it can cause cancer in animals, so a low threshold has been set for the amount of substance allowed in food products and medicines. The use ofA smoking cessation product lasts for several weeks, so there is no risk to users of the problematic product either, as they have not been exposed to a large amount of the substance for a long time.
Pfizer found that in several batches of the drug Champix, out of hundreds of batches apparently, the amount of the substance exceeded the desired levels (although did not come close to levels considered dangerous). Pfizer is currently in the process of testing all of the Champix batches it has produced, to see if the amount of nitrosamine has exceeded the standard in other batches as well.
No packs of medicine arrived in Israel from the batches that were found to be problematic, but as stated, the test is still ongoing and the problem may be discovered in additional batches. It is not yet known how long the test will last and when it will be possible to use Champix again.
In some states, smokers are told to continue using the drug if they have it, but not to start using it if they do not currently do so. This, among other things, with the thought that the risk of further smoking outweighs any risk that may arise from the product.
In Israel, it was decided to stop using the product even by those who have already purchased it or are in the middle of the smoking cessation process, which should take several weeks. Those who are in the process, which usually includes the use of smoking substitutes (such as nicotine gum) as well as mental support, can continue to try to quit with the help of the whole supportive shell but without the medicine. Those who do not succeed in this, will be able to try again when the product returns to the shelves.
It is possible that the Ministry of Health has chosen a path of extreme caution compared to some of the other regulators in this matter, due to the increased attention it receives from the relationship between the ministry and Pfizer. This is due to the unique agreement between the State of Israel and the Ministry of Health and Pfizer, according to which Israel exclusively buys vaccines from Corona from Pfizer, and has been given priority in the supply of vaccines, in exchange for access to information on the effect of vaccines on corona morbidity rates. The Ministry of Health has an interest in showing that it does not make any concessions to Pfizer.
The ministry said: “The Ministry of Health acted immediately after the company’s announcement and carried out a level 3 recall as a Pfizer company announcement. The material was taken from the shops, as was the case with other regulatory authorities, such as Canada.
“After a professional discussion in the Ministry of Health, it was decided to take a more serious recall (level 1) than those taken by regulatory authorities around the world, which means returning the drug from the client’s homes to the pharmacy. As mentioned, there are other authorities in the world
Also, after consulting with various professional bodies, it was decided to publish regular guidelines for the public of doctors and patients tomorrow as part of the return of the drug to pharmacies. “