All Posts Tagged With: "Label Change"
Chantix Label Revision
FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of [...]
Popularity: 50% [?]
27Feb2008 | PharmaWatchDog | 0 comments | Continued
More on Chantix
Many new drugs initially enjoy banner sales growth, only to get kneecapped by reports of previously unknown adverse side effects. On Friday, the FDA issued an alert “highlighting” a stricter warning label for one of Pfizer’s most important new drugs.
The compound in question, Chantix, is one of the most recent non-nicotine stop-smoking treatments on the [...]
Popularity: 46% [?]
5Feb2008 | PharmaWatchDog | 0 comments | Continued
FDA Says Stop-Smoking Drug May Pose Psychiatric Risks
The Food and Drug Administration issued a public health advisory about suicidal thinking and other psychiatric conditions in patients taking the smoking cessation drug Chantix, warning that it “may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur.”
Learn More: Washington [...]
Popularity: 40% [?]
2Feb2008 | PharmaWatchDog | 2 comments | Continued
The FDA has ordered a black box warning on the use of mycophenolate mofetil (CellCept) during pregnancy
The FDA has ordered a black box warning on the use of mycophenolate mofetil (CellCept) during pregnancy.
In announcing the label change, the agency cited an increased risk of spontaneous abortion or congenital malformation for transplant patients who become pregnant while using the immunosuppressant.
Post-marketing data from the National Transplantation Pregnancy Registry (NTPR) and worldwide adverse event [...]
Popularity: 42% [?]
30Oct2007 | PharmaWatchDog | 0 comments | Continued
