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Risedronate induced transient ocular myasthenia
2007-12-28 12:24:00
A case of ocular myasthenia gravis induced by risedronate therapy for osteoporosis in a 81 years old lady has been reported in The Journal of Postgraduate Medicine. On Applying the Naranjo's adverse drug reactions (ADR) probability scale, a causality assessment was made which categorized this reaction as probable with a score of 7.Source: J Postgrad Med 2007;53:274-5http://www.jpgmonline.com/te xt.asp?2007/53/4/274/37525
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Drug rash with eosinophilia and systemic symptoms syndrome due to quinine
2007-12-28 12:19:00
A case of a 58 years old male patient with drug rash with eosinophilia and systemic symptoms (DRESS) syndrome due to quinine has been published in the Journal of Postgraduate Medicine.On Naranjo scale it scored 5, classifying it as a probable adverse drug reaction.Source: J Postgrad Med 2007;53:272-3http://www.jpgmonline.com/te xt.asp?2007/53/4/272/37523
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Tobramycin induced Hepatotoxicity
2007-12-26 12:31:00
A case of a hepatotoxicity occuring as a result of tobramycin adminstration has been published in the December issue of the Annals of Pharmacotherapy.Liver enzymes rose when tobramycin therapy was initiated, markedly increased when the tobramycin dose was increased, then resolved upon discontinuation of therapy. Other medication-related causes were ruled out by temporal relationship or rechallenge (aztreonam). Use of the Naranjo probability scale indicated a possible relationship between hepatotoxicity and tobramycin therapy. Other adverse reaction scales specific for evaluation of drug-induced liver disease were also used. Both the Council for International Organizations of Medical Sciences and Maria and Victorino scales indicated a probable likelihood of tobramycin-induced hepatotoxicity.Reference: The Annals of Pharmacotherapy 2007;41(12): 2061-2065.http://www.theannals.com/cgi/co ntent/abstract/41/12/2061

Lumiracoxib
2007-12-26 12:23:00
The European Medicines Agency (EMEA) has recommended the withdrawal of the marketing authorisations for all lumiracoxib-containing medicines, because of the risk of serious side effects affecting the liver. Lumiracoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group ‘COX-2 inhibitors’. It is used for symptomatic relief in the treatment of osteoarthritis of the hip and knee.Source: http://www.emea.europa.eu/pdfs/human/pres s/pr/PR_Lumiracoxib_57930107en.pdf

Carbamazepine
2007-12-19 05:40:00
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. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from areas in which HLA-B*1502 is present should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine. If these individuals test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is true for patients of any ethnicity or genotype, including patients positive f...
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Radio Frequency Ablation Devices
2007-12-19 05:38:00
FDA alerted healthcare professionals of reports of patient deaths associated with the use of radio frequency (RF) ablation devices during lung tumor ablation. Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities. While RF ablation devices have been cleared for general indications- ablation of soft tissue by thermal coagulation necrosis- the devices have not been cleared specifically for lung tumor ablation. Healthcare professionals should use caution when operating RF ablation devices, adhering strictly to information contained in the labeled operating instructions, Operators Manual, the Manufacturer's Instructions for Use and any training provided. Additionally, if healthcare professionals plan to use RF ablation devices to treat patients with lung tumors, they should consider enrolling patients in an approved clinical study, where training is available. Source: http://www.fda.gov/cdr...
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Electric Dental Handpieces
2007-12-19 05:34:00
FDA informed healthcare professionals about serious patient injuries, including third degree burns, associated with the use of poorly maintained electric dental handpieces during dental procedures. Some patients had third degree burns which required plastic surgery. Burns may not be apparent to the operator or the patient until after the tissue damage occurred, because the anesthetized patient cannot feel the tissue burning and the handpiece housing insulates the operator from the heated attachment. Although the reported burns occurred during the cutting of tooth and bone, tooth extraction and other dental surgical procedures, overheating can also occur during any dental procedure. This problem is not limited to dentistry. Rotary surgical handpieces can cause patient burns during orthopedic procedures, as reported in the July 2003 edition of FDA Patient Safety News (http://www.fda.gov/cdrh/psn/show17-burns .html). Read the FDA Public Health Notification for specific actions to preven...
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PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate
2007-12-19 05:23:00
Merck & Co. and FDA informed healthcare professionals and consumers of a voluntary recall of eleven lots of PedvaxHIB and two lots of COMVAX vaccines. The vaccines were recalled because the manufacturer cannot assure sterility of the affected lots. Routine testing of the vaccine manufacturing equipment used to produce PedvaxHIB and COMVAX identified the presence of Bacillus cereus bacteria. Sterility tests of the vaccine lots themselves have not found any contamination. The affected doses were distributed in the U.S. starting in April 2007. Healthcare professionals should immediately discontinue use of any of the affected lots and follow the manufacturer's instructions for returning recalled vaccines. See the FDA Consumer Update (link given below) for a list of the specific lots of each vaccine recalled. Source: http://www.fda.gov/consumer/updates/hib12 1307.html
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Cardiac Risks associated with Omeprazole
2007-12-19 05:19:00
FDA informed healthcare professionals of the issuance of the Agency's follow-up communication regarding its review of safety data for the drugs omeprazole and esomeprazole that raised concerns about a potential increased risk of heart problems for patients treated with these drugs. The Agency conducted a comprehensive review of the data from two studies that were submitted to FDA. FDA continues to believe that long-term use of omeprazole or esomeprazole is not likely to be associated with an increased risk of heart problems and recommends that healthcare providers continue to prescribe and patients continue to use these products in the manner described in the labeling for the two products. Source: http://www.fda.gov/cder/drug/early_comm/o meprazole_esomepazole_update.htm

Cefepime
2007-11-30 11:12:00
FDA issued an early communication about the ongoing review of new safety data and the request for additional data to further evaluate the risk of death in patients treated with cefepime. An article in the May 2007 issue of The Lancet Infectious Diseases (Efficacy and safety of cefepime: a systematic review and meta-analysis) raised the question about increased mortality with the use of cefepime, a broad spectrum B-lactam antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. The article describes a higher all-cause mortality in patients treated with cefepime compared to other B-lactam antibiotics. Until FDA's evaluation is completed, healthcare professionals who are considering the use of cefepime should be aware of the risks and benefits described in the product's prescribing information and the new information from this meta-analysis.Source: http://www.fda.gov/cder/drug/early_comm/c efepime.htm

Varenicline and Neuropsychiatric disorders
2007-11-30 11:03:00
FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking. Healthcare professionals should monitor patients taking Chantix for behavio...
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Myfortic (mycophenolic acid) Delayed-Release Tablets
2007-11-30 10:56:00
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. The pregnancy category for Myfortic has been changed to Category D (Positive evidence of fetal risk). This change is a result of postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil (MMF) during pregnancy. MMF is converted to the active ingredient in Myfortic, following oral or intravenous administration. A patient who is planning a pregnancy should not use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs. Healthcare professionals should discuss the risks and benefits of Myfortic as well as alternative immunosuppressant therapy with the patient. Female patients of childbearing potential must receive contraceptive c...
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Flu drugs and neuropsychiatric changes.
2007-11-30 10:43:00
The FDA’s Pediatric Advisory Committee has recommended changing the label of Roche’s flu medication Tamiflu to reflect the potential for neuropsychiatric adverse events, but it did not specify what changes should be made. The relationship between Tamiflu (oseltamivir phosphate) and neuropsychiatric adverse events, including suicides, cannot be determined, the FDA said. Committee members proposed including an indication that the adverse events are sometimes fatal and adding language showing the uncertainty over the drug’s causal effect. The committee also voted to change the labeling of GlaxoSmithKline’s (GSK) Relenza (zanamivir) to reflect an increase in adverse event reports but did not determine what the changes should be or whether the label should be the same as Tamiflu’s. Last year, Roche revised its Tamiflu package insert to add warnings about the potential for self-injury and confusion, particularly in pediatric patients. Twenty-five patients younger than 21 years...
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Teratogenicity associated with mycophenolate mofetil
2007-10-30 09:11:00
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. Based on postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil during pregnancy, the pregnancy category for CellCept has been changed from Category C (risk of fetal harm cannot be ruled out) to Category D (positive evidence of fetal risk). Within one week of beginning CellCept therapy, women of childbearing potential should have a negative serum or urine pregnancy test. In addition, women of childbearing potential (including pubertal girls and peri-menopausal woman) taking CellCept must receive contraceptive couns...
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Intramuscular Methotrexate-Induced Aseptic Meningitis
2007-10-26 11:27:00
A case of a 62-year-old male presenting on 3 separate occasions with symptoms consistent with aseptic meningitis: 2 requiring hospitalization and 1 noted during a subsequent ambulatory care visit, has been published in the latest issue of Annals of Pharmacotherapy.Methotrexate-induced aseptic meningitis has been reported in the literature; however, in those cases, the effect occurred only when methotrexate was given via the intrathecal route. The Naranjo probability scale indicates a probable relationship between the development of the condition and the methotrexate use in this patient.Source: The Annals of Pharmacotherapy 2007;41(11):1906-1911.http://www.theannal s.com/cgi/content/abstract/41/11/1906

FDA Advisory Committees Recommend Against Cough and Cold Medications in Chi
2007-10-24 06:21:00
Citing a lack of proven effectiveness and a need for clinical trials in children, the FDA’s Nonprescription Drugs and Pediatric Advisory Committees recommended the ingredients in cough and cold medications not be used in children younger than 6.The agency convened a two-day meeting in response to a citizen petition requesting the FDA not allow the drugs to be marketed for children younger than 6. The petition was filed by the Baltimore City Health Department on behalf of several hospitals and universities. Although the petitioners’ request applies to children younger than 6, the agency told the committees any actions it takes could apply to children younger than 12.The FDA is not required to accept advisory committee recommendations but usually does. Petitioners testifying to the committees argued, based on review of published studies, that cough and cold products intended for use in children have not been proven effective. Therefore, any adverse events associated with their use...
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Sildenafil, Tadalafil and Vardenafil.
2007-10-22 11:32:00
FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors Viagra (Sildenafil ), Levitra (Vardenafil ), Cialis (Tadalafil) for the treatment of erectile dysfunction, and Revatio (Sildenafil) for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for Viagra, Levitra, and Cialis were revised. FDA is working with the manufacturer to revise the labeling for Revatio.Source: http://www.fda.gov/medwatch/safety/2007/s afety07.htm
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Acute Pancreatitis Associated with Exenatide
2007-10-18 13:18:00
FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking exenatide, a drug used to treat adults with type 2 diabetes. An association between Exenatide and acute pancreatitis is suspected in some of these cases. Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Exenatide to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Exenatide should be discontinued. If pancreatitis is confirmed, Exenatide should not be restarted unless an alternative etiology is identified. Source: http://www.fda.gov/cder/drug/infopage/exe natide/default.htm
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Atrial Fibrillation associated with Bisphosphonates
2007-10-03 06:23:00
FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer. FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation.In addition, as part of the data review for the recent approval of once-yearly Reclast (Zoledronic Acid) for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast. Most cases of atrial fibrillation occurred more than a month...
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FDA Takes Action To Stop Marketing Of Unapproved Hydrocodone Products
2007-10-01 06:58:00
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 coughsuppressant and to treat pain.The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death,if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills andjudgment. The FDA has received reports of medication errors associated withformulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products. Most of the hydrocodone formulations now marketed to suppress coughs have not been approved. The agency isparticularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants (also known as antitussives), and the risk of medication error involving the una...
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The number of Serious Adverse Events doubles in seven years in the US
2007-09-22 20:11:00
The number of reported serious adverse events from drug treatment more than doubled in the United States from 1998 to 2005, rising from 34,966 to 89,842.Over the same period the number of deaths relating to drugs nearly tripled, from 5519 to 15 107, show data from the US Food and Drug Administration's adverse event reporting system, which collects all reports of adverse events submitted voluntarily to the agency either directly or through drug manufacturers.Source: Archives of Internal Medicine 2007;167:1752-9.BMJ 2007;335:585 (22 September), doi:10.1136/bmj.39339.624711.DB http://www.bmj.com/cgi/content/extract/33 5/7620/585-a
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Oral Aloe Vera induced Hepatitis
2007-09-22 20:06:00
A case of a 73-year-old female admitted to the hospital for acute hepatitis has been published in the Annals of Pharmacotherapy. Extensive laboratory testing did not reveal the cause of the patient's disease. She was asked multiple times whether she was taking any home medications, which she initially denied. It was only after an extensive medication history done by a clinical pharmacist that the patient admitted to using oral aloe vera capsules for constipation. Upon discontinuation of the oral aloe vera, liver markers of hepatotoxicity returned to normal levels. Using the Roussel Uclaf Causality Assessment Method for determining drug hepatotoxicity, the patient's symptoms were scored as probably caused by oral aloe vera.Source: The Annals of Pharmacotherapy 2007;41(10):1740-1743.http://www.theannal s.com/cgi/content/abstract/41/10/1740
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Visual Loss associated with Povidone-Iodine Pleurodesis
2007-09-20 06:45:00
Three cases of bilateral severe loss of vision (ranging from 20/800 vision to the perception of hand motions only) after thoracoscopic surgery involving resection of parts of one lung and instillation of 200 to 500 ml of Jodobac, a 10% povidone–iodine solution, into the thoracic cavity for disinfection and to cause scarring of the pleura for prophylaxis against pneumothorax have been reported in the latest issue of the New England Journal Of Medicine.Source: NEJM 2007;357(12):1264-65.http://content.nejm. org/cgi/content/full/357/12/1264
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Aplastic Anemia associated with Temozolomide
2007-09-19 07:51:00
A safety review of temozolomide identified cases of aplastic anemia, some fatal, associated with use of the drug. Healthcare professionals should be alert to the possibility of aplastic anemia in the setting of refractory or prolonged myelosuppression in patients receiving temozolomide and report cases to FDA's MedWatch.From August 11, 1999, to November 3, 2006, FDA received 18 (domestic-14, foreign-4) reports of aplastic anemia among patients receiving temozolomide. Product labeling currently includes a warning regarding myelosuppression and describes pancytopenia among reported adverse events.Source: http://www.fda.gov/cder/dsn/2007_fall/pos tmarketing.htm#Temozolomide
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Serious Skin Reactions Associated with Modafinil
2007-09-19 07:48:00
Modafinil (Provigil) is an oral wakefulness-promoting agent to treat patients with excessive sleepiness (ES) associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep disorder (SWSD).FDA has been monitoring cases of serious skin reactions, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), in its postmarketing reviews of adverse event reports associated with the use of modafinil. The product labeling for modafinil has been recently updated to include a bolded warning for serious rash, including SJS.Source: http://www.fda.gov/cder/dsn/2007_fall/pos tmarketing.htm#modafinil
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Progressive Multifocal Leukoencephalopathy (PML) associated with Rituximab
2007-09-19 07:44:00
A safety review on rituximab identified an association of the drug with a serious adverse event, progressive multifocal leukoencephalopathy (PML), a viral infection of the central nervous system. The product labeling has been updated to reflect this new safety information, and a public health advisory and information for healthcare professionals have been posted on FDA's Web site.As of December 2006, FDA has received a total of 24 reports of PML in patients who received rituximab treatment.Source: http://www.fda.gov/cder/dsn/2007_fall/pos tmarketing.htm#Rituximab
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Cardiovascular Risk with Haloperidol
2007-09-18 17:35:00
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. Although injectable haloperidol is only approved by the FDA for intramuscular injection, there is considerable evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice. There are at least 28 case reports of QT prolongation and TdP, some with fatal outcome in the context of off-label intravenous haloperidol. Healthcare professionals should consider this new risk information when making individual treatment decisions for their patients.Source: http://www.fda.gov/cder/drug/InfoSheets/H CP/haloperidol.htm
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Potential Risk Associated With Concomitant Use Of Ceftriaxone With Calcium
2007-09-12 06:04:00
Roche informed healthcare professionals about revisions made to the prescribing information for Rocephin (Ceftriaxone Sodium) to clarify the potential risk associated with concomitant use of Rocephin with calcium or calcium-containing solutions or products. Healthcare professionals are advised that Rocephin and calcium-containing solutions including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites. Rocephin and IV calcium-containing solutions should not be administered within 48 hours of each other in any patient. No data are available on the potential interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral). Source: http://www.fda.gov/medwatch/safety/2007/s afety07.htm#Rocephin
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valproate-induced hyperammonemic encephalopathy
2007-09-11 06:24:00
A case of valproate-induced hyperammonemic encephalopathy in a 18 years old female being prescribed valproate 750mg per day for temporal lobe epilepsy and having normal liver function has been published in Canadian Medical Association Journal.Source: CMAJ. September 11, 2007; 177 (6). doi:10.1503/cmaj.061272.http://www.cmaj.c a/cgi/content/full/177/6/568
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Viracept (nelfinavir mesylate) and guidance on use in pregnant women and pe
2007-09-11 06:07:00
Pfizer issued a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate (EMS), a process-related impurity in Viracept and to provide guidance on the useof Viracept in pregnant women and pediatric patients. EMS is a potential human carcinogen. Data from animal studies indicate EMS is teratogenic, mutagenic and carcinogenic; however, no data from humans exist. FDA has asked Pfizer to implement new specifications to limit the presence ofEMS in Pfizer-manufactured Viracept products marked in the UnitedStates. For pediatric patients who are stable on Viracept-containing regimens, FDA and Pfizer agree that the benefit-risk ratio remains favorable and those patients may continue to receive Viracept. Pediatric patients who need to begin HIV treatment should not start regimens containingViracept until further notice. Pregnant women who need to begin antiretroviral therapy should not be offered regimens containingViracept until further ...
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