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
EU Approves Cipralex for Obsessive Compulsive Disorder
Cipralex (escitalopram, manufactured by Lundbeck; in the US the drug is called Lexapro) has been approved in Europe for treating obsessive-compulsive disorder (OCD). OCD is a chronic disorder characterized by recurrent thoughts and impulses (obsession) and/or repetitive behavior (compulsion). A 24-week study of Cipralex in OCD showed that the 10 mg/day and 20 mg/day dosage of Cipralex were effective in terating OCD. A placebo comparison showed that the 20 mg/day dose of Cipralex showed reduction of symptoms and increase in remission rates. A comparison with paroxetine (brand name Paxil in US and Seroxat in EU) showed that Cipralex had fewer withdrawal symptoms. Given that Cipralex is a member drug of the SSRI class, patients should be aware of the safety profiles and risk relating to this class of drug. Side effects may include nausea, insomnia, problems with ejaculation, somnolence, increased sweating, fatigue, decreased libido, and anorgasmia. Source for side effect information: Cipralex and Lexapro websites.