FDA Drug Safety Communication: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin)

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary     Safety Announcement [07-29-2010] The U.S. Food and Drug Administration (FDA) is informing patients and healthcare professionals about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug. Cubicin was first approved in September 2003 to treat serious skin…

FDA Drug Safety Communication: Aseptic meningitis associated with use of Lamictal (lamotrigine)

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [08-12-2010] The U.S. Food and Drug Administration (FDA) is informing the public that Lamictal (lamotrigine)†, a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic meningitis. FDA is revising the Warnings and…

FDA Drug Safety Communication: Update: Follow up to the Public Health Alert about Changes to the Heparin Sodium USP Monograph

Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data Summary Table to Distinguish Between “New” and “Old” Heparin Safety Announcement [04-07-2010] Laboratory studies performed at the request of the U.S. Food and Drug Administration (FDA) have shown that Heparin Sodium, USP (heparin) made under the new United States Pharmacopeia (USP) Monograph (“new…

FDA Drug Safety Communication: New Boxed Warning on severe liver injury with propylthiouracil

Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data Summary Safety Announcement [04-21-2010] The United States Food and Drug Administration (FDA) has added a Boxed Warning to the label for propylthiouracil, a drug used to treat hyperthyroidism (overactive thyroid), to include information about reports of severe liver injury and acute liver failure,…

FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate)

Safety Announcement Additional Information for Patients  Additional Information for Healthcare Professionals Data Summary   Safety Announcement  [07-08-2010] Due to continued reports of serious side effects in patients using Qualaquin “off-label” (a non-FDA-approved use) for night time leg cramps, the U.S. Food and Drug Administration (FDA) has approved a risk management plan to warn against the…

FDA Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines; requires label changes

FDA investigated several safety issues associated with the class of opioid pain medicines: Serotonin syndrome Adrenal insufficiency Androgen deficiency Serotonin syndrome A search of the FDA Adverse Event Reporting System (FAERS) database for the period January 1, 1969, to June 12, 2013, identified 43 cases of serotonin syndrome in which opioids were used concomitantly with…

FDA Statement on Avandia TIDE Trial

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