Chantix Early Warning on Suicide Ideation
Chantix (varenicline, manufactured by Pfizer) is a prescription drug to help adults stop smoking. You may have also seen ads during prime time TV. I’ve seen them as sponsors to ABC’s web episodes, which requires you to watch a Chantix ad before you could watch the episode.
According to the FDA website, “An Early Communication reflects FDA’s current analysis of available data concerning these drugs and does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue.”
Based on FDA’s request for information from the manufacturer, Pfizer, Inc., the company recently submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.
FDA’s Center for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.
In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
FDA also advises that, due to reports of drowsiness, patients should use caution when driving or operating machinery until they know how using Chantix may affect them.
Full text of the Early Communication about the Ongoing Safety Review can be found at: http://www.fda.gov/cder/drug/early_comm/varenicline.htm.
FDA Proposes Suicide Ideation Warnings for Antidepressant Use in Young Adults
According to the FDA, it is proposing drug companies to update their antidepressant product labeling to include warnings of increased suicidality, defined as “increased risks of suicidal thinking and behavior” in adults ages 18 to 24 during the first two months of treatment. On the other hand, data suggests that adults ages 65 and older have reduced suicidality with antidepressants. This proposal will affect the entire category of antidepressants, and that available information could not exclude a single medication from this increased suicidality risk.
Here’s what one of my (pharma industry) colleagues Steve thinks about the black box warning.
Unsafe Psych Meds from Internet Pharmacies
The FDA is warning consumers about unsafe drugs from internet “pharmacies”. The drugs listed from the FDA alert page includes psychiatric medications like Ambien, Xanax, Lexapro, and Ativan, which were not the drugs that the customer received, but were substances containing a powerful anti-psychotic called haloperidol. This has resulted in ER visits by consumer victims, who suffered from breathing problems, muscle spasms and muscle stiffness. Other haloperidol side effects include agitation, and sedation. Haloperidol is used to treat schizophrenia.
FDA became aware of this problem after a consumer complaint was brought to a U.S. drug company making the branded product. These tablets were packaged with a Greece postmark.
The origin of these tablets is unknown but the packages were postmarked in Greece and looks like this.
Consumers bought these from different websites selling prescription medications.
Source: FDA website