Mental Health Blogs

The FDA today put out a list of drugs for which it ordered new warnings and other labeling changes in August. Among the drugs was Pristiq, Wyeth’s newish anti-depressant that is a metabolite of Effexor.

Under “warnings” on the drug’s package insert, the agency ordered the following update:

“Elevated Blood Pressure:

“Has occurred with Pristiq. hypertension should be controlled before initiating treatment. Monitor blood pressure regularly during treatment.”

Under “adverse reactions,” the agency ordered the following update:

“Clinical Studies Experience:

“Adverse reactions in patients in short-term fixed-dose studies (incidence ≥ 5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.

The FDA adverse events database lists four reports of sexual dysfunction to date.

Sounds like yet another lovely anti-depressant.

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