The Food and Drug Administration has issued a stern warning over the use of Chantix as well as its side effects. The warning is mainly to the heavy drinkers who are said to become more aggressive after the use of this quit–smoking drug by Pfizer. It has been linked to seizures and since a revision of its drug’s label done in September last year, FDA has cautioned that the users must familiarize themselves with the specific changes.
These are changes on the label that must be put at the forefront at the time of prescription include a very specific “black box” warning.
According to FDA, their warning on the black box which was issued three years after Chantix was approved is mostly for the very serious risks. It is a tablet that should be taken twice a day. Apparently, the label describes Chantix as one drug having numerous side effects the likes of serious hostility and violent bizarre besides harboring of suicidal thoughts.
Many debates are currently running on various medical journals and platforms detailing the safety of Chantix after Pfizer, the biopharmaceutical firm behind it requested FDA to bring down the black box warning. Pfizer is arguing that there is no direct link between Chantix and the claimed psychiatric effects.
However, the government has still maintained its stand of having the black box on the label citing that it will have to look at the results of an ongoing research. The government has also indicated that the research Pfizer is using to justify their request still has various limitations hence it cannot completely rely on its findings.
Its invalidity was given more weight by recommendations of a panel of external experts as at last year October. As such doctors have been advised on weighing out the risks of this drug against its benefits.
That said Pfizer has since mounted another new study as they still try to outdo the black box warning by FDA.