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    December 20, 2006 : Medication Adverse Event Alert about rituximab (Rituxan®) "The Food and Drug Administration (FDA) is alerting health care professionals and patients treated with Rituxan (rituximab) to reports of an emerging risk of a serious side effect in patients receiving or who have used Rituxan. [more...] November 30, 2006 : Medication Adverse Event Alert about Methadone HCl "FDA notified healthcare professionals of reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone. These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone's cardiac toxicities (QT prolongation and Torsades de Pointes). [more...] November 20, 2006 : Medication Adverse Event Alert about Erythropoiesis Stimulating Agents "FDA notified healthcare professionals of a newly published clinical study showing that patients treated with an erythropoiesis-stimulating agent (ESA) and dosed to a target hemoglobin concentration of 13.5 g/dL are at a significantly increased risk for serious and life threatening cardiovascular complications, as compared to use of the ESA to target a hemoglobin concentration of 11.3 g/dL. [more...] November 14, 2006 : Medication Adverse Event Alert about Tamiflu® "Roche and FDA notified healthcare professionals of revisions to the PRECAUTIONS/Neuropsychiatric Events and Patient Information sections of the prescribing information for Tamiflu, indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days and for the prophylaxis of influenza in patients 1 year and older. [more...] November 10, 2006 : Medication Recall Alert about ACETAMINOPHEN 500MG CAPLETS "FDA Informs Public of Nationwide Recall of 500mg Strength Store-Brand Acetaminophen Caplets The U.S. Food and Drug Administration (FDA) is alerting the public to a voluntary recall being conducted by Perrigo Company (Perrigo) of Allegan, Michigan for 383 lots of acetaminophen 500mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets. [more...] October 25, 2006 : Medication Adverse Event Alert about Venlafaxine Hydrochloride Postmarketing surveillance of venlafaxine has revealed reports of overdosage resulting in an increased risk of fatal outcome compared to SSRI antidepressant agents, but the risk was lower than that for tricyclic antidepressants. [more...] October 20, 2006 : Medication Adverse Event Alert about Imatinib Mesylate Under FDA direction, Novartis has revised the PRECAUTIONS section of the prescribing information for imatinib and has sent out a "Dear Healthcare Professional" letter to warn about the potential for severe congestive heart failure and left ventricular dysfunction that has been reported in patients taking imatinib. [more...] October 10, 2006 : Medication Adverse Event Alert about Lamotrigine The FDA announced that recent data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry suggest a possible link between lamotrigine use during the 1st trimester of pregnancy and cleft lip and/or cleft palate. It reported that the total prevalence reported for oral cleft cases among lamotrigine-exposed infants is 8.9 per 1000 as compared to 0.50 to 2.16 in studies with non-exposed infants (Holmes et.al). [more...] October 10, 2006 : National Provider ID Number to Become Standard Health Identifier Beginning May 23, 2007, the National Provider Identifier (NPI) number will become the standard unique identifier for all health care providers. [more...] September 29, 2006 : Medication Adverse Event Alert about bevacizumab (Avastin) The FDA has announced that in post marketing surveillance, the use of bevacizumab has resulted in several cases of reversible posterior leukoencephalophathy syndrome (RPLS) and nasal septal perforation. [more...] September 26, 2006 : Medication Adverse Effect Alert about ORTHO EVRA The FDA announced that of the 2 recent epidemiological studies conducted evaluating the risk of a serious blood clot in women using Ortho Evra compared to using an oral contraceptive, the first study show similar risk while the second study showed that the Ortho Evra group had a 2-fold increase in venous thromboembolism (VTE) over the oral contraceptive group. [more...] September 11, 2006 : Medication Interaction Alert about IBUPROFEN and ASPIRIN When taken together, ibuprofen can decrease the antiplatelet effect of aspirin and potentially decrease the cardioprotection and stroke prevention activity of aspirin. [more...] August 25, 2006 : New Warnings about Dexedrine (dextroamphetamine sulfate) The FDA and GlaxoSmithKline notified healthcare professionals of changes to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the prescribing information for Dexedrine (dextroamphetamine sulfate), approved for the treatment of Attention-Deficit Hyperactivity Disorder and narcolepsy. [more...] The FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. [more...] July 21, 2006 : New Warnings about triptans. (Axert, Amerge, Imitrex, Frova, Zomig, Relpax, Maxalt) The FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). [more...] May 24, 2006 : Recall of Insulin Syringes Boca Medical Products and the FDA notified consumers and healthcare professionals of an extension of an earlier recall of Ultilet insulin syringes and the additional recall of Closercare insulin syringes because of bacterial contamination with Paenibacillus. [more...] May 22, 2006 : Recall: tacrolimus for compounding Spectrum Laboratory Products and the FDA notified healthcare professionals of the recall of the active pharmaceutical ingredient tacrolimus, an immunosuppressive drug used to prevent rejections of transplanted solid organs such as heart or kidney, after learning that some lots of the ingredient are subpotent. [more...] May 19, 2006 : New Warnings about Tequin (gatifloxacin) Bristol-Myers Squibb has decided to discontinue the commercialization of Tequin (gatifloxacin) tablets and injection. They have decided to cease shipping the product to wholesalers in the United States effective June 2, 2006. [more...] May 15, 2006 : New Warnings about Paxil and Paxil CR (paroxetine) GlaxoSmithKline (GSK) and the FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the prescribing Information for Paxil and Paxil CR (paroxetine). [more...] May 5, 2006 : New Warnings for oral sodium phosphates The FDA notified healthcare professionals and consumers of reports of acute phosphate nephropathy, a type of acute renal failure, that is a rare, but serious adverse event associated with the use of oral sodium phosphates (OSP) for bowel cleansing. [more...] April 19, 2006 : Recall of Ultilet Insulin Syringe 30g 1/2cc Boca Medical Products and the FDA notified consumers and healthcare professionals of a recall of Ultilet Insulin Syringe 30g 1/2cc (Lot # - 5GEXI, NDC # - 08326-3002-50) because of possible bacterial presence of Bacillus Cereus and Staphylococcus Intermedius. [more...] April 11, 2006 : New Warnings about Macugen (pegaptanib sodium injection) Pfizer Pharmaceuticals notified healthcare professionals of important changes in the approved product labeling for Macugen (pegaptanib sodium injection), including changes to the CONTRAINDICATIONS, PRECAUTIONS, ADVERSE EVENTS Post-Marketing, and DOSAGE and ADMINISTRATION sections. [more...] March 31, 2006 : Drug Shortage/Discontinuation Notice for Pancrease (pancrelipase capsules) McNeil Consumer and Specialty Pharmaceuticals has announced the discontinuation of the drug Pancrease (pancrelipase). Other pancrelipase products will continue to be available. [more...] March 6, 2006 : Updated Drug Warnings on Tracleer (bosentan) Actelion and the FDA notified healthcare professionals of changes to the Tracleer (bosentan) prescribing information based on cases of hepatotoxity reported. Tracleer is indicated for the treatment of pulmonary arterial hypertension. [more...] February 17, 2006 : New Warnings about Tequin (gatifloxacin) Bristol-Myers Squibb Co. announced labeling changes for Tequin (gatifloxacin), an antibiotic indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections including infections of urinary tract, kidneys and skin. [more...] February 16, 2006 : New Warnings for Benzocaine Sprays The FDA issued a Public Health Advisory to notify healthcare professionals and patients about adverse events, including methemoglobinemia, associated with the use of benzocaine sprays used in the mouth and throat. [more...] February 14, 2006 : New Warnings for Coreg® (carvedilol) GSK has announced a temporary shortfall in the supply of Coreg® (carvedilol) in the US. During this time, patients may experience difficulty in filling their Coreg prescriptions. [more...] January 30, 2006 : New Warnings about Hydrea/Droxia (hydroxyurea) Bristol-Myers Squibb notified healthcare professionals about revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for Hydrea and Droxia (hydroxyurea capsules) to describe cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, in patients with myeloproliferative disorders during therapy with hydroxyurea, most often reported in patients with a history of or currently receiving interferon therapy. [more...] January 25, 2006 : New Warnings about Ketek (telithromycin) In the January 20, 2006, "Annals of Internal Medicine" an article was published reporting three patients who experienced serious liver toxicity following the administration of Ketek (telithromycin). These cases were also reported to FDA MedWatch. [more...] January 18, 2006 : New Warnings about Clozaril (clozapine) Novartis and the FDA notified healthcare professionals of revisions to the BOXED WARNING, WARNINGS, CONTRAINDICATIONS, PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information (PI) for Clozaril (clozapine) tablets. [more...] January 2, 2006 : New Warnings for Avandia® (rosiglitazone) GlaxoSmithKline and FDA notified healthcare professionals about post-marketing reports of new onset and worsening diabetic macular edema for patients receiving rosiglitazone. [more...]
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