FDA Makes Safety Labeling Changes to Prevacid
May 2012 Safety Labeling Changes includes 41 products with revisions to Prescribing Informatio n
Prevacid is one of the 41 labels being changed as per the FDA. The change will be in the Precautions and Warnings section of the Prevacid label.
Added to the Precautions and Warnings sections is: Concomitant Use of PREVACID with Methotrexate (5.4)
It was added to the label because according to the new label, “Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients”.
Also added to the new label is a Drug Interactions warning: Methotrexate: PREVACID may increase serum levels of methotrexate. (7.6)
The new label will now state under Drug Interactions, “Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of high dose methotrexate with PPIs have been conducted [see Warnings and Precautions (5.4)].”
Click Here For More Information on Prevacid.
Generic Prevacid (lansoprazole) Recall
On April 15, 2011, the U.S. Food & Drug Administration (FDA) announced that lansoprazole was being recalled after numerous reports that the pills had clogged and jammed medical equipment despite being designed to dissolve when suspended in liquid. A number of patients have even required emergency care after their feeding tubes became clogged by the pills. But despite the nationwide recall, FDA is warning the public that hospitals and pharmacies are not being asked to return the drug and may still have it in stock.
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