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Early Communication About Ongoing Safety Review of Spiriva
The FDA announced that it is investigating the results from several recent clinical studies involving Spiriva (tiotropium), including the UPLIFT trial that the FDA first notified the public about in March 2008. These studies raised concerns about an increased risk of stroke, heart complications, and death in patients taking Spiriva when compared to patients who were taking placebo. Spiriva is a medication that is indicated for the long-term treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. For more information please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070651.htm
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Important Information About Safe Use of Children's Cough and Cold Medicine
Based on consultations with the U.S. Food and Drug Administration (FDA), major over-the-counter (OTC) medicine makers are updating the labels on over-the-counter children's cough and cold medicines. These products often include one or more of the following medications: acetaminophen, chlorpheniramine, dextromethorphan, diphenhydramine, guaifenesin, or phenylephrine. The new labels advise parents to not use these products in children under age 4 (previously children under age 2). This safety alert may be applied to brand or generic versions of children's cough and cold medicine. Examples of some of the brand name products included in this safety alert can be found here: http://otcsafety.org/Media/128678607135956061.pdf In addition, certain antihistamines will also have updated labels, advising parents not to use them to make their children sleepy. Antihistamines, like diphenydramine (Benadryl) or chlorpheniramine (Chlor-Trimeton), are often used to treat runny noses, sneezing, itching and other allergic reactions. For more information please visit: http://otcsafety.org/Important_Information_about_Children%27s_Cough_and_Cold_Medicine.aspx
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Date Published Title Drug Source
2008-10-08 Early Communication About Ongoing Safety Review of Spiriva Tiotropium FDA
2008-10-08 Important Information About Safe Use of Children's Cough and Cold Medicine Acetaminophen Manufacturer
2008-10-03 First Reported Case of Progressive Multifocal Leukoencephalopathy (PML) in a Raptiva Patient Efalizumab Manufacturer
2008-09-23 Use Tarceva (Erlotinib) with Caution in Patients with Liver Problems Erlotinib Manufacturer
2008-09-18 FDA Stops Imports of Ranbaxy Products Acyclovir FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Amoxicillin FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Amoxicillin Sodium with Clavulanate Potassium FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Carbidopa / Levodopa FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Cefaclor FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Cefadroxil FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Cefpodoxime FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Cefprozil FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Cefuroxime FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Cephalexin FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Ciprofloxacin FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Clarithromycin FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Fenofibrate FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Fluconazole FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Fosinopril FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Gabapentin FDA