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October 25, 2004

Black box warnings to be added to all antidepressants

Black box warnings to be added to all antidepressants A Public Health Advisory has been issued by the FDA announcing its multipronged strategy to warn the public about the increased risk of suicidality in children and adolescents being treated with antidepressant medications. The agency is directing all manufacturers to add a black box warning to the labels of all antidepressants to describe this risk and stress the need for close monitoring of patients started on these medications. The second element of the strategy is to develop a Patient Medication Guide intended to be distributed by the pharmacist with each prescription or refill of such a medication. In addition, the FDA will work with the manufacturers to implement unit-of-use packaging for all antidepressants to ensure patients receive the MedGuide. The labeling changes apply to all antidepressants because the currently available data are not adequate to exclude any single medication from the increased risk of suicidality.

Pharmacists laud CDC flu vaccine strategy Pharmacists around the country have been generally supportive of CDC's plan to get the flu vaccine to high-risk patients in the wake of a manufacturing debacle that has left the nation with only half of its scheduled doses. CDC announced that 14.2 million doses of the vaccine out of the 22.4 million that Aventis Pasteur hasn't yet shipped would be allocated to pediatricians, nursing homes, and long-term care facilities. VA medical centers as well as the Department of Defense are also considered high-priority targets. CDC expects to keep about 4.5 million doses in its stockpile.

Survey shows some wholesalers price gouging A survey of more than 2,800 hospital pharmacy directors conducted by ASHP found that opportunistic vendors offering to sell the flu vaccine at highly inflated prices have contacted more than 55% of the respondents. Of these, more than 80% reported being offered the vaccine at more than four times the original market value and nearly 20% have been offered the vaccine at $800 or more per 10-dose vial (more than 10 times the original market value). ASHP is advising R.Ph.s to stay vigilant regarding the potential for counterfeit or diverted flu vaccine.

Independents fight compounding standards NCPA is lobbying to strike down language in an FDA appropriations bill directing the agency to partner with U.S. Pharmacopeia to develop national, enforceable standards for all compounded human drugs. Such standards would limit compounding to USP monographs and would usurp the rights of state pharmacy boards to regulate pharmacy practice, according to a resolution unanimously adopted by delegates at the recent NCPA annual meeting in Boston.

New warning added to Centocor label In a Dear Healthcare Professional letter, Centocor detailed revisions made to the label of its TNF-alpha blocker, infliximab (Remicade), indicated for the treatment of rheumatoid arthritis and Crohn's disease. In controlled studies of all TNF-alpha blockers, more cases of lymphoma have been observed among patients receiving the agents than among the control groups. In open-label, uncontrolled studies, malignancies have been observed at a rate several times higher than expected in the general population. Patients with Crohn's disease or RA, especially those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk than the general population for the development of lymphoma. In response, a warning concerning malignancy has been added to infliximab's labeling.

Abilify OK'd for acute bipolar mania Aripiprazole (Abilify, Bristol-Myers Squibb/Otsuka Pharmaceuticals) has been approved for the treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar disorder. Aripiprazole was approved by the FDA in 2002 for the treatment of schizophrenia.

FDA gives Caduet new indication Amlodipine/atorvastatin (Caduet, Pfizer) has been approved to prevent cardiovascular disease and lower the risk of myocardial infarction in those with hypertension and other risk factors. Amlodipine/ atorvastatin was previously approved for the treatment of hypertension and dyslipidemia.