A case of acute stroke in a 43 years old female patient who was receiving high-dose intravenous immune globulin (IVIG) for dermatomyositis has been published in the American Journal of Health System Pharmacy.
Although rare, stroke associated with thrombosis caused by the administration of IVIG has been reported in the literature. On the basis of the Naranjo probability scale, this adverse drug event was calculated as a probable reaction due to the administration of IVIG.
Source: American Journal of Health-System Pharmacy, Vol. 64, Issue 15, 1611-1614
http://www.ajhp.org/cgi/content/abstract/64/15/1611
Thursday, August 30, 2007
Elevated serum transaminase levels resulting from concomitant use of rosuvastatin and amiodarone
The case of a 73 years old female patient whose serum transaminase levels became elevated after concomitant use of rosuvastatin and amiodarone has been published in the current issue of American Journal of Health System Pharmacy.
Source: American Journal of Health-System Pharmacy, Vol. 64, Issue 17, 1818-1821
http://www.ajhp.org/cgi/content/abstract/64/17/1818
Source: American Journal of Health-System Pharmacy, Vol. 64, Issue 17, 1818-1821
http://www.ajhp.org/cgi/content/abstract/64/17/1818
Wednesday, August 29, 2007
Indian Drug Regulator to get serious about Pharmacovigilance
The Indian drug regulator is planning a major overhaul in the country’s drug adverse reaction monitoring system.
The Central Drugs Standard Control Organisation is now planning to appoint a team of about 100 clinical pharmacologists across the country, on a contract basis, to collect adverse drug reaction reports and patient complaints from hospitals, clinics and practising clinicians.
“We are not taking any chances now, because the domestic pharma market is growing and a host of new drugs are being launched by domestic as well as foreign companies,” said M. Venkateswarlu, India’s drug controller general. “Though the new drugs are approved after verifying the clinical trial data, this will not be enough to establish the absolute safety of a drug as these are conducted in limited number of volunteers or patients, which are only indicative. So a regular post-marketing study will only provide the actual response (effects and side effects) of the drug as it has been practically used in a wider patient pool.”
Though it is the responsibility of drug manufacturers to do these studies on newly marketed drugs and submit the data to the regulator, the system has been a failure in India as most companies flout the law.
As a result, the country had hardly any drug recalls, even though several drugs marketed here are alleged to have a doubtful safety profile. The system could also be an early-warning system unlike recent cases, including recall controversies over GlaxoSmithKline Plc.’s Avandia diabetes drug and the voluntary recall of cardiac stents by Johnson & Johnson, where Indian authorities are still seeking information from their Western counterparts and the multinational drug companies.
Source and detailed report: http://www.livemint.com/2007/08/27004814/Drug-regulator-to-monitor-side.html
The Central Drugs Standard Control Organisation is now planning to appoint a team of about 100 clinical pharmacologists across the country, on a contract basis, to collect adverse drug reaction reports and patient complaints from hospitals, clinics and practising clinicians.
“We are not taking any chances now, because the domestic pharma market is growing and a host of new drugs are being launched by domestic as well as foreign companies,” said M. Venkateswarlu, India’s drug controller general. “Though the new drugs are approved after verifying the clinical trial data, this will not be enough to establish the absolute safety of a drug as these are conducted in limited number of volunteers or patients, which are only indicative. So a regular post-marketing study will only provide the actual response (effects and side effects) of the drug as it has been practically used in a wider patient pool.”
Though it is the responsibility of drug manufacturers to do these studies on newly marketed drugs and submit the data to the regulator, the system has been a failure in India as most companies flout the law.
As a result, the country had hardly any drug recalls, even though several drugs marketed here are alleged to have a doubtful safety profile. The system could also be an early-warning system unlike recent cases, including recall controversies over GlaxoSmithKline Plc.’s Avandia diabetes drug and the voluntary recall of cardiac stents by Johnson & Johnson, where Indian authorities are still seeking information from their Western counterparts and the multinational drug companies.
Source and detailed report: http://www.livemint.com/2007/08/27004814/Drug-regulator-to-monitor-side.html
Monday, August 27, 2007
Eli Lilly to Cease Sale of Pergolide Due to Risk of Cardiac Valvulopathy
Eli Lilly Canada Inc., in collaboration with Health Canada, has informed healthcare professionals that sales of Permax will cease in Canada as of August 30, 2007.
Subsequent to new post-market safety information coming from two papers published in the January 4, 2007 issue of the New England Journal of Medicine (NEJM) that provided further evidence consistent with previous reports of valvulopathy cases in patients taking pergolide,1 2 Health Canada considers that there is insufficient evidence to support the continued safe use of Permax under the current recommendations outlined in the Product Monograph.
Source and detailed report: http://www.docguide.com/news/content.nsf/news/852571020057CCF685257339005C676C?OpenDocument&id=48DDE4A73E09A969852568880078C249&c=Parkinson&count=10
Subsequent to new post-market safety information coming from two papers published in the January 4, 2007 issue of the New England Journal of Medicine (NEJM) that provided further evidence consistent with previous reports of valvulopathy cases in patients taking pergolide,1 2 Health Canada considers that there is insufficient evidence to support the continued safe use of Permax under the current recommendations outlined in the Product Monograph.
Source and detailed report: http://www.docguide.com/news/content.nsf/news/852571020057CCF685257339005C676C?OpenDocument&id=48DDE4A73E09A969852568880078C249&c=Parkinson&count=10
Thursday, August 16, 2007
Risperidone- and Quetiapine-Induced Cholestasis
The Annals of Pharmacotherapy describes a case of a patient who developed drug-induced cholestasis after being on risperidone maintenance therapy for 8 years.
A 30-year-old male with schizoaffective disorder, bipolar type, and insulin-dependent diabetes mellitus had been stable on risperidone 6 mg at night for 8 years. His other medications included lithium 900 mg twice daily and enalapril 5 mg daily, as well as regular insulin and NPH insulin as needed. The patient developed cholestasis that resolved once risperidone was discontinued. Over the next 11 months, he tolerated trials of ziprasidone and olanzapine. When quetiapine was initiated, the patient developed signs and symptoms of cholestasis within 3 weeks after starting this medication. The signs and symptoms of cholestasis resolved with removal of quetiapine. The Naranjo probability scale indicated that these atypical antipsychotics (risperidone and quetiapine) were the probable cause of cholestasis in this patient.
Source: Annals of Pharmacotherapy 2007;41(9):1518-1523.
http://www.theannals.com/cgi/content/abstract/41/9/1518
A 30-year-old male with schizoaffective disorder, bipolar type, and insulin-dependent diabetes mellitus had been stable on risperidone 6 mg at night for 8 years. His other medications included lithium 900 mg twice daily and enalapril 5 mg daily, as well as regular insulin and NPH insulin as needed. The patient developed cholestasis that resolved once risperidone was discontinued. Over the next 11 months, he tolerated trials of ziprasidone and olanzapine. When quetiapine was initiated, the patient developed signs and symptoms of cholestasis within 3 weeks after starting this medication. The signs and symptoms of cholestasis resolved with removal of quetiapine. The Naranjo probability scale indicated that these atypical antipsychotics (risperidone and quetiapine) were the probable cause of cholestasis in this patient.
Source: Annals of Pharmacotherapy 2007;41(9):1518-1523.
http://www.theannals.com/cgi/content/abstract/41/9/1518
Pegfilgrastim-Induced Hyperleukocytosis
Annals of Pharmacotherapy has reported a pediatric case of pegfilgrastim-induced hyperleukocytosis.
A 3-year-old boy with medulloblastoma therapy presented with white blood cell (WBC) count 0.1 x 103/µL and absolute neutrophil count (ANC) 0.014 x 103/µL on day 27 following a course of induction chemotherapy. The patient received pegfilgrastim 200 µg/kg the following day. On his return 6 days later for the next planned course of chemotherapy, hyperleukocytosis was determined, with WBC 149 x 103/µL and ANC 110 x 103/µL ("neutrophil overshoot"). No sources of the elevated WBC count other than administration of pegfilgrastim (eg, steroids, antiepileptics, infection) were present. Chemotherapy was delayed until the WBC count had fallen to 35.2 x 103/µL (ANC 28.9 x 103/µL). No sequelae from this adverse effect occurred.
Use of the Naranjo probability scale suggested that pegfilgrastim was the probable cause of hyperleukocytosis in the patient.
Source: Annals of Pharmacotherapy 2007;41(9):1524-1530.
http://www.theannals.com/cgi/content/abstract/41/9/1524
A 3-year-old boy with medulloblastoma therapy presented with white blood cell (WBC) count 0.1 x 103/µL and absolute neutrophil count (ANC) 0.014 x 103/µL on day 27 following a course of induction chemotherapy. The patient received pegfilgrastim 200 µg/kg the following day. On his return 6 days later for the next planned course of chemotherapy, hyperleukocytosis was determined, with WBC 149 x 103/µL and ANC 110 x 103/µL ("neutrophil overshoot"). No sources of the elevated WBC count other than administration of pegfilgrastim (eg, steroids, antiepileptics, infection) were present. Chemotherapy was delayed until the WBC count had fallen to 35.2 x 103/µL (ANC 28.9 x 103/µL). No sequelae from this adverse effect occurred.
Use of the Naranjo probability scale suggested that pegfilgrastim was the probable cause of hyperleukocytosis in the patient.
Source: Annals of Pharmacotherapy 2007;41(9):1524-1530.
http://www.theannals.com/cgi/content/abstract/41/9/1524
Amlodipine-Induced Bilateral Upper Extremity Edema
A case of bilateral upper extremity edema associated with Amlodipine use has been reported in the latest issue of The Annals of Pharmacotherapy.
A previously well and normotensive 6-year-old girl presented with a generalized vasculitis of unknown origin and severe hypertension. Large vessels predominantly affecting the neck, chest, and abdomen were found to be involved, resulting in abnormal arterial circulation and significant blood pressure differences between the upper and lower extremities. Multiple antihypertensive agents were initially required to control blood pressure. She was stabilized and discharged on amlodipine 10 mg each evening, atenolol 50 mg/day, and warfarin. Three days later she was noted to have facial and bilateral upper extremity pitting edema. Laboratory and radiologic assessments for possible etiologies were negative. Discontinuation of amlodipine resulted in resolution of edema. According to the Naranjo probability scale, amlodipine was a probable cause of bilateral upper extremity edema in this child.
Source: The Annals of Pharmacotherapy 2007;41(9):1536-38.
http://www.theannals.com/cgi/content/abstract/41/9/1536
A previously well and normotensive 6-year-old girl presented with a generalized vasculitis of unknown origin and severe hypertension. Large vessels predominantly affecting the neck, chest, and abdomen were found to be involved, resulting in abnormal arterial circulation and significant blood pressure differences between the upper and lower extremities. Multiple antihypertensive agents were initially required to control blood pressure. She was stabilized and discharged on amlodipine 10 mg each evening, atenolol 50 mg/day, and warfarin. Three days later she was noted to have facial and bilateral upper extremity pitting edema. Laboratory and radiologic assessments for possible etiologies were negative. Discontinuation of amlodipine resulted in resolution of edema. According to the Naranjo probability scale, amlodipine was a probable cause of bilateral upper extremity edema in this child.
Source: The Annals of Pharmacotherapy 2007;41(9):1536-38.
http://www.theannals.com/cgi/content/abstract/41/9/1536
Thiazolidinediones (Glitazones)
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. These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Manufacturers of certain drugs have agreed to the upgraded warning.
The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their healthcare providers to discuss alternative treatments.
Source: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01683.html
The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their healthcare providers to discuss alternative treatments.
Source: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01683.html
Nonprescription Cough and Cold Medicine Use in Children
FDA announced that on October 18 - 19, 2007, the Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under two years of age. In preparation for the meeting, FDA is reviewing safety and efficacy data for the ingredients of these products.
Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the “Drug Facts” box on the package label. The Public Health Advisory offers parents and caregivers of children recommendations when using cough and cold products in children.
Complete Advisory: http://www.fda.gov/cder/drug/advisory/cough_cold.htm
Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the “Drug Facts” box on the package label. The Public Health Advisory offers parents and caregivers of children recommendations when using cough and cold products in children.
Complete Advisory: http://www.fda.gov/cder/drug/advisory/cough_cold.htm
Tuesday, August 14, 2007
Lopinavir/ Ritonavir Oral Solution (Kaletra)
Abbott Laboratories disseminated a Dear Healthcare Provider Letter throughout the world to physicians and pharmacists that prescribe/distribute Kaletra Oral Solution. The letter informed healthcare professionals of an accidental overdose that occurred with a pediatric patient taking Kaletra Oral Solution. The infant received a significantly large dose of Kaletra and subsequently died. Healthcare professionals should pay special attention to accurate calculation of the dose of Kaletra, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors.
Source: http://www.fda.gov/medwatch/safety/2007/safety07.htm#kaletra
Dear Healthcare Professional Letter - Abbot [PDF]: http://www.fda.gov/medwatch/safety/2007/Kaletra_DHCP.pdf
Source: http://www.fda.gov/medwatch/safety/2007/safety07.htm#kaletra
Dear Healthcare Professional Letter - Abbot [PDF]: http://www.fda.gov/medwatch/safety/2007/Kaletra_DHCP.pdf
Australian Medicines Regulator cancels registration of Lumiracoxib
Australia's medicines Regulator, the Therapeutic Goods Administration (TGA) has cancelled the registration of the osteoarthritis drug, Lumiracoxib because of serious liver side effects associated with the use of the drug.
Lumiracoxib, marketed by Novartis Pharmaceuticals under the brand name of Prexige, is a Cox 2 inhibitor belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDS).
As of 10 August 2007, the TGA had received eight reports of serious liver adverse reactions associated with use of lumiracoxib, including two deaths and two patients requiring liver transplants. All these reports have been received since March 2007, with 6 reports received in the last 6 weeks. The TGA has urgently investigated these reports and as a result has acted to deregister the drug to prevent further cases of liver damage related to lumiracoxib.
Although there is limited data on the natural history of the hepatic side effects of lumiracoxib, the pre-registration clinical trial data suggested that if a patient developed elevated liver function tests while on the drug, they were likely to normalise their biochemistry when the lumiracoxib was ceased. However, in the 8 serious Australian reports studied, some patients have not improved on cessation of the medicine, due to the severity of the hepatic injury.
The TGA and its expert advisory committee, the Adverse Drug Reactions Advisory Committee (ADRAC), have urgently investigated these reports. ADRAC has today recommended the cancellation of the registration of Lumiracoxib due to the severity of the reported side effects associated with this drug.
The regulator has labelled it as a Class I defect. Class I defects are potentially life-threatening or could cause a serious risk to health.
The TGA has thus advised that all patients cease taking lumiracoxib immediately, and are assessed by their doctor for any clinical or biochemical evidence of liver damage.
Recall letters are expected to be dispatched by the sponsor within the next week.
Source: http://www.tga.gov.au/alerts/prexige.htm
http://www.tga.gov.au/recalls/2007/lumiracoxib.htm
http://www.tga.gov.au/media/2007/070811-lumiracoxib.htm
Lumiracoxib, marketed by Novartis Pharmaceuticals under the brand name of Prexige, is a Cox 2 inhibitor belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDS).
As of 10 August 2007, the TGA had received eight reports of serious liver adverse reactions associated with use of lumiracoxib, including two deaths and two patients requiring liver transplants. All these reports have been received since March 2007, with 6 reports received in the last 6 weeks. The TGA has urgently investigated these reports and as a result has acted to deregister the drug to prevent further cases of liver damage related to lumiracoxib.
Although there is limited data on the natural history of the hepatic side effects of lumiracoxib, the pre-registration clinical trial data suggested that if a patient developed elevated liver function tests while on the drug, they were likely to normalise their biochemistry when the lumiracoxib was ceased. However, in the 8 serious Australian reports studied, some patients have not improved on cessation of the medicine, due to the severity of the hepatic injury.
The TGA and its expert advisory committee, the Adverse Drug Reactions Advisory Committee (ADRAC), have urgently investigated these reports. ADRAC has today recommended the cancellation of the registration of Lumiracoxib due to the severity of the reported side effects associated with this drug.
The regulator has labelled it as a Class I defect. Class I defects are potentially life-threatening or could cause a serious risk to health.
The TGA has thus advised that all patients cease taking lumiracoxib immediately, and are assessed by their doctor for any clinical or biochemical evidence of liver damage.
Recall letters are expected to be dispatched by the sponsor within the next week.
Source: http://www.tga.gov.au/alerts/prexige.htm
http://www.tga.gov.au/recalls/2007/lumiracoxib.htm
http://www.tga.gov.au/media/2007/070811-lumiracoxib.htm
Sunday, August 12, 2007
European Commission Suspends Roche's License To Market Antiretroviral Viracept (Nelfinavir)
The European Commission has suspended Swiss drugmaker Roche's licence to market the HIV drug Viracept (Nelfinavir) in the European Union.
"The suspension is due to the contamination of certain lots of Viracept with ethyl mesilate, a genotoxic substance," the EU executive said in a statement.
The suspension follows the withdrawal of the drug from the market in June when Roche said its licence for Viracept was being temporarily suspended pending a review by authorities.
The Commission said Tuesday's announcement was based on the scientific conclusions from the European Medicines Agency (EMEA) and consultations with EU member states.
"The suspension could only be lifted by a further decision by the Commission, after the evaluation of new data given by the Agency," the EU executive said.
In June, Roche said it had identified a chemical impurity in the product, leading to the recall in Europe and some other regions.
Source: http://www.reuters.com/article/companyNewsAndPR/idUSL0734726920070807
"The suspension is due to the contamination of certain lots of Viracept with ethyl mesilate, a genotoxic substance," the EU executive said in a statement.
The suspension follows the withdrawal of the drug from the market in June when Roche said its licence for Viracept was being temporarily suspended pending a review by authorities.
The Commission said Tuesday's announcement was based on the scientific conclusions from the European Medicines Agency (EMEA) and consultations with EU member states.
"The suspension could only be lifted by a further decision by the Commission, after the evaluation of new data given by the Agency," the EU executive said.
In June, Roche said it had identified a chemical impurity in the product, leading to the recall in Europe and some other regions.
Source: http://www.reuters.com/article/companyNewsAndPR/idUSL0734726920070807
Friday, August 10, 2007
Early Communication About an Ongoing Safety Review - Omeprazole and Esomeprazole
FDA issued an early communication about the ongoing review of new safety data for the proton pump inhibitors, Prilosec (Omeprazole) and Nexium (Esomeprazole). The new safety data was from two small long-term clinical studies in patients with severe gastroesophageal reflux disease (GERD). In both studies, patients were randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their GERD.
The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. After reviewing these and other data submitted by the company, FDA's preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.
Source: http://www.fda.gov/cder/drug/early_comm/omeprazole_esomeprazole.htm
The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. After reviewing these and other data submitted by the company, FDA's preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.
Source: http://www.fda.gov/cder/drug/early_comm/omeprazole_esomeprazole.htm
Tuesday, August 7, 2007
Potential Drug Interactions with Tizanidine
Acorda Therapeutics recently alerted healthcare professionals about new contraindications for Zanaflex. Zanaflex (tizanidine) is used to treat spasticity.
New labeling says that this drug should not be used concomitantly with either of two CYP1A2 inhibitors: fluvoxamine, which is used to treat depression and anxiety disorders, or the antibiotic ciprofloxacin. Taking either of these drugs together with tizanidine can cause dangerously elevated serum levels of tizanidine, which can lead to side effects such as severe hypotension and sedation. The company says that other CYP1A2 inhibitors may also lead to substantial increases in tizanidine blood concentrations, although there have been no clinical studies to substantiate this. Therefore, using tizanidine with other CYP1A2 inhibitors should ordinarily be avoided. These drugs include zileuton, other fluoroquinolones, antiarrythmics, H-2 blockers, oral contraceptives, acyclovir and ticlopidine.
Source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=66#7
New labeling says that this drug should not be used concomitantly with either of two CYP1A2 inhibitors: fluvoxamine, which is used to treat depression and anxiety disorders, or the antibiotic ciprofloxacin. Taking either of these drugs together with tizanidine can cause dangerously elevated serum levels of tizanidine, which can lead to side effects such as severe hypotension and sedation. The company says that other CYP1A2 inhibitors may also lead to substantial increases in tizanidine blood concentrations, although there have been no clinical studies to substantiate this. Therefore, using tizanidine with other CYP1A2 inhibitors should ordinarily be avoided. These drugs include zileuton, other fluoroquinolones, antiarrythmics, H-2 blockers, oral contraceptives, acyclovir and ticlopidine.
Source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=66#7
New Warnings on Defarasirox
Novartis has notified healthcare professionals that new warnings have been added to the labeling for Exjade (defarasirox). Exjade is used to treat transfusional hemosiderosis, the chronic iron overload that can result from blood transfusions.
Cases of acute renal failure, some of them fatal, have been reported in patients taking this drug. Most occurred in patients with multiple co-morbidities who were in advanced stages of their hematological disorders.
Before beginning therapy with Exjade, all patients should have their serum creatinine assessed in duplicate to establish a baseline level, and then creatinine should be monitored monthly during treatment. Patients who may be at increased risk of complications should be monitored weekly during the first month of Exjade therapy or when the treatment is modified, and then monthly thereafter. These high-risk patients include the elderly, people with pre-existing renal disease or other co-morbid conditions, and those receiving drugs that can depress renal function. There have also been reports of cytopenias in patients on Exjade, some of them fatal. The relationship between the drug and these effects is uncertain, since most of the patients had pre-existing hematological disorders that themselves are associated with bone marrow failure. Blood counts should be monitored regularly and treatment interrupted in patients who develop unexplained cytopenia.
Source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=66#4
Cases of acute renal failure, some of them fatal, have been reported in patients taking this drug. Most occurred in patients with multiple co-morbidities who were in advanced stages of their hematological disorders.
Before beginning therapy with Exjade, all patients should have their serum creatinine assessed in duplicate to establish a baseline level, and then creatinine should be monitored monthly during treatment. Patients who may be at increased risk of complications should be monitored weekly during the first month of Exjade therapy or when the treatment is modified, and then monthly thereafter. These high-risk patients include the elderly, people with pre-existing renal disease or other co-morbid conditions, and those receiving drugs that can depress renal function. There have also been reports of cytopenias in patients on Exjade, some of them fatal. The relationship between the drug and these effects is uncertain, since most of the patients had pre-existing hematological disorders that themselves are associated with bone marrow failure. Blood counts should be monitored regularly and treatment interrupted in patients who develop unexplained cytopenia.
Source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=66#4
Subscribe to:
Posts (Atom)
