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"FDA informed healthcare professionals that dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. [more...] December 4, 2007 : Medication Adverse Event Alert about desmopressin "FDA notified healthcare professionals and patients of the Agency's request that manufacturers update the prescribing information for desmopressin to include important new safety information about severe hyponatremia and seizures. [more...] November 29, 2007 : Medication Discontinuation Alert for Roferon-A® "[The] production of ROFERON-A(Interferon alfa-2a, recombinant) has been discontinued for the United States market and sale of ROFERON-A will be discontinued when existing supply for the U.S. is depleted, which is estimated to be early to mid-2008. [more...] November 27, 2007 : Medication Label Change Alert for Myfortic® "Novartis and FDA informed healthcare professionals and patients that use of Myfortic Delayed- Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. [more...] November 20, 2007 : Medication Safety Alert for Varenicline (Chantix®) "FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. [more...] November 14, 2007 : Medication Safety Alert for Avandia® (rosiglitazone) "FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. [more...] November 5, 2007 : Medication Discontinuation Alert for Exubera® "On Thursday Oct 18th, Pfizer announced that it will be returning the worldwide rights for Exubera (insulin human [rDNA origin]) Inhalation Powder back to Nektar, the company from which we licensed the inhaled insulin technology. [more...] October 29, 2007 : Medication Label Change Alert for CellCept® (mycophenolate mofetil) "Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney [more...] October 24, 2007 : Medication Safety Review Alert about Modafinil (Provigil®) "FDA and Cephalon notified healthcare professionals of updates to the WARNINGS section of the prescribing information for Provigil (modafinil). [more...] October 16, 2007 : Medication Adverse Event Alert about Byetta® (exenatide) "FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. [more...] October 1, 2007 : FDA Action Item Alert about Hydrocodone Products "FDA informed healthcare professionals and consumers of its intent to take action against companies that market unapproved prescription products containing hydrocodone, a narcotic widely used as a cough suppressant and to treat pain. [more...] September 18, 2007 : Medication Adverse Event Alert about Haldol® "Johnson and Johnson and FDA informed healthcare professionals that the WARNINGS section of the prescribing information for haloperidol has been revised to include a new Cardiovascular subsection regarding cases of sudden death, QT prolongation and Torsades de Pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. [more...] September 14, 2007 : Medication Adverse Event Alert about Fentora® "Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora. [more...] September 11, 2007 : Glucometer Event Alert "Abbott is initiating a worldwide medical device correction for users of its Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid®and Kroger® blood glucose meters manufactured after January 31, 2007. [more...] September 11, 2007 : Medication Adverse Event Alert about Viracept® "Viracept was recently recalled from the European market due to unacceptably high levels of an impurity known as ethyl methanesulfonate (EMS). [more...] August 21, 2007 : Medication Labeling Alert about Coumadin® "FDA approved updated labeling to include pharmacogenomics information to the CLINICAL PHARMACOLOGY, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for the widely used blood-thinning drug, Coumadin. [more...] August 15, 2007 : Medication Safety Alert about Thiazolidinedione Class of Antidiabetic Drugs "After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. [more...] July 27, 2007 : Medication Re-release Alert about Zelnorm® "The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines. [more...] July 5, 2007 : Medication Recall Alert about Invanz® "Merck and FDA informed healthcare professionals that 3 lots of Invanz (0803930, 0803940, and 0803950), a product indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated microorganisms, were recalled. [more...] July 3, 2007 : Medication Adverse Event Alert about Xolair® "Genetech and FDA informed healthcare professionals and asthmatic patients that the prescribing information for Xolair was revised to include a new BOXED WARNING, and updated WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections that address the risk of anaphylaxis (the onset of action can be delayed for 24 hours or more) when taking this medication. [more...] May 22, 2007 : Medication Labeling Change Alert about Exjade® "Novartis and FDA notified healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the product labeling for Exjade, a drug used to treat chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. [more...] May 21, 2007 : Medication Safety Alert about Avandia® "FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes mellitus. [more...] May 2, 2007 : Medication Recall Alert about Colchicine "ApothéCure and FDA notified all healthcare professionals of recent deaths associated with the use of compounded injectable Colchicine 0.5mg/ml, 4ml vials, lot number 20070122@26. [more...] May 2, 2007 : Updated Blackbox Warning Alert for all Antidepressant Medications "FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. [more...] April 12, 2007 : Medication Interaction Alert about Zanaflex® "Acorda Therapeutics and FDA informed healthcare professionals of changes to the CONTRAINDICATIONS and WARNINGS Sections of the product labeling for Zanaflex, a drug used to treat spasticity. [more...] April 11, 2007 : Medication Recall Alert about Griseofulvin "Ortho-McNeil and FDA informed healthcare professionals and consumers of a nationwide recall of griseofulvin oral suspension, a prescription medication used to treat ringworm and other fungal infections. [more...] April 11, 2007 : Medication Tampering Alert about Combivir "GlaxoSmithKline and FDA informed healthcare professionals of an apparent third-party tampering that resulted in the misbranding of Ziagen as Combivir and employed counterfeit labels for Combivir Tablets. [more...] April 9, 2007 : Medication Event Alert about Trimethobenzamide "FDA notified healthcare professionals and consumers that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride. [more...] March 30, 2007 : Medication Withdrawal Alert about Zelnorm® (tegaserod) FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. [more...] March 29, 2007 : Medication Withdrawal Alert about Permax® (pergolide) FDA notified healthcare professionals and patients that companies that manufacture and distribute pergolide have agreed to withdraw the drug from the market. [more...] March 19, 2007 : Medication Adverse Event Alert about Zyvox® (linezolid), Pharmacia "FDA is issuing this alert to advise you of new emerging safety concerns about Zyvox (linezolid) from a recent clinical study. [more...] March 13, 2007 : Medication Adverse Event Alert about erythropoiesis-stimulating agents (ESAs) "FDA notified healthcare professionals of new safety information for erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa). [more...] March 9, 2007 : Medication Adverse Event Alert about pioglitazone "Takeda and FDA notified healthcare professionals of recent safety data concerning pioglitazone-containing products. The results of an analysis of the manufacturer's clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a comparator (either placebo or active). [more...] "Roche and FDA notified cardiac transplant healthcare practitioners about a clinical study (Heart Spare The Nephron) that was terminated due to an observed increased incidence of grade IIIA acute rejection in heart transplant patients switched from calcineurin inhibitor and CellCept to Rapamune (sirolimus) and CellCept at 12 weeks post heart transplantation. [more...] "FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the MICROBIOLOGY/Antiviral Activity and INDICATIONS AND USAGE/Description of Clinical Studies/Special Populations sections of the prescribing information for Baraclude. [more...] February 21, 2007 : Medication Adverse Event Alert about Xolair® (omalizumab) " FDA notified asthmatic patients and healthcare professionals of new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair (omalizumab). Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection. [more...] February 21, 2007 : Medication Adverse Event Alert about Rosiglitazone "Glaxo SmithKline (GSK) notified healthcare professionals of the results of a randomized, double-blind parallel group study [ADOPT] of 4,360 patients with recently diagnosed type 2 diabetes mellitus followed for 4-6 years to compare glycemic control with rosiglitazone relative to metformin and glyburide monotherapies. [more...] "FDA informed consumers and healthcare professionals regarding the possible dangers of buying prescription medications online. Individuals who ordered Ambien, Xanax, Lexapro, and Ativan over the internet received a product that contained haloperidol, a powerful anti-psychotic drug. [more...] February 14, 2007 : Medication Adverse Event Alert about Rotateq® (rotavirus vaccine) "The Food and Drug Administration (FDA) is notifying health care providers and consumers about 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (trade name RotaTeq), manufactured by Merck and Co., Inc. [more...] February 13, 2007 : Medication Adverse Event Alert about Ketek® (telithromycin), Sanofi Aventis "The Food and Drug Administration (FDA) today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients. [more...] February 7, 2007 : Medication Adverse Event Alert about topical anesthetics "FDA is issuing this advisory to alert you to the potential hazards of using skin numbing products, also known as topical anesthetics, for cosmetic procedures. These topical anesthetics contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. [more...] "Amgen notified the oncology medical community of the results of a large, multicenter, randomized, placebo-controlled study showing that Aranesp was ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who have anemia that is not due to concurrent chemotherapy. [more...] "The Centers for Disease Control and Prevention (CDC) issued a Morbidity and Mortality Weekly Report (MMWR) article describing three deaths in U.S. infants aged less than 12 months associated with cough and cold medications. These medications were determined by medical examiners or coroners to be the underlying cause of death. [more...]
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