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New FDA Warnings and Alerts

Posted by 4love2love on June 19, 2011

FDA Medwatch Alert

June 13, 2011
ISSUE: Novo Nordisk reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy (REMS). The letter is being sent because a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza.
FDA Medwatch Alert

June 13, 2011
ISSUE: FDA notified healthcare professionals and the public of medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.


News Alert

Sleeptime Head-Cooling Cap Eases Insomnia, Study Finds

June 14, 2011

TUESDAY, June 14 — Not only do cooler heads prevail, they might also sleep better, according to researchers who say they have developed a cooling cap that, when worn during sleeptime, may help treat insomnia.

Read more…


FDA Medwatch Alert

June 15, 2011
[UPDATED 06/15/2011] Use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.


FDA MedWatch Alert

June 15, 2011
ISSUE: Bedford Laboratories, a division of Ben Venue Laboratories, Inc., initiated a nationwide voluntary recall of Indomethacin for Injection, USP, 1mg Single Dose Vial (NDC #55390-299-01, Lot 1948138, Exp. Date September 2011) as it may contain particulate matter. The particulate matter has been identified as active drug substance and not foreign material or contamination.  Particulate matter may provoke an immune reaction and/or lead to microinfarcts which could be serious and life threatening.

FDA MedWatch Alert

June 16, 2011
ISSUE: FDA notified healthcare professionals and patients that the Prescribing Information for this drug product will be strengthened to inform the public that use of varenicline may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section and the patient Medication Guide.



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