Pharmacovigilance

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Acute hepatitis attack after exposure to telithromycin
2007-09-06 07:37:00
A case of 25 years old male patient having been prescribed 400 mg of Telithromycin for an upper respiratory tract infection and presenting with Jaundice, nausea and malaise has been published in Clinical Therapeutics.Pathological Examination revealed 'drug induced toxic hepatitis' and the Naranjo adverse drug reaction probability scale had a score of 8 for this case.Source: Clin Ther 2007;29:1725-1729.http://www.clinicalther apeutics.com/articles/1725_onu.pdf
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High-Dose Prexige (Lumiracoxib) Withdrawn in New Zealand
2007-09-03 14:21:00
New Zealand ’s drug regulatory authority, Medsafe, has canceled the registration of 200- and 400-mg tablets of the Cox-2 inhibitor Prexige after reviewing local and international reports of severe liver damage in patients taking high doses of the drug.The move comes just over a week after Australia’s Therapeutic Goods Administration (TGA) withdrew Novartis’ pain killer altogether. The TGA’s decision was in response to eight serious reactions, including two deaths and two liver transplants.The 100-mg Prexige (lumiracoxib) tablet remains on the market in New Zealand. The drug is used for the management of osteoarthritis.Source: http://www.medsafe.govt.nz/hot/media/2007 /Prexige.asp
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Acute stroke with high-dose intravenous immune globulin
2007-08-30 07:25:00
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, 1611-1614http://www.ajhp.org/cgi/content/ abstract/64/15/1611
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Elevated serum transaminase levels resulting from concomitant use of rosuva
2007-08-30 07:21:00
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, 1818-1821http://www.ajhp.org/cgi/content/ abstract/64/17/1818
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Indian Drug Regulator to get serious about Pharmacovigilance
2007-08-29 06:24:00
The Indian drug regulator is planning a major overhaul in the country’s drug adverse reaction monitoring system.The Central Drug s 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 ...
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Eli Lilly to Cease Sale of Pergolide Due to Risk of Cardiac Valvulopathy
2007-08-27 06:37:00
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?Ope nDocument&id=48DDE4A73E09A96985256888 0078C249&c=Parkinson&count=10
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Risperidone- and Quetiapine-Induced Cholestasis
2007-08-16 17:40:00
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: An...
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Pegfilgrastim-Induced Hyperleukocytosis
2007-08-16 17:34:00
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;...
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Amlodipine-Induced Bilateral Upper Extremity Edema
2007-08-16 17:23:00
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 bi...
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Thiazolidinediones (Glitazones)
2007-08-16 17:20:00
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/N EW01683.html
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Nonprescription Cough and Cold Medicine Use in Children
2007-08-16 17:16:00
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 ...
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Lopinavir/ Ritonavir Oral Solution (Kaletra)
2007-08-14 19:09:00
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/s afety07.htm#kaletraDear Healthcare Professional Letter - Abbot [PDF]: http://www.fda.gov/medwatch/safety/2007/K aletra_DHCP.pdf
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Australian Medicines Regulator cancels registration of Lumiracoxib
2007-08-14 18:32:00
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 clin...
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Avandia to stay on Market
2007-07-31 06:25:00
A federal drug advisory committee voted overwhelmingly on Monday to recommend that the diabetes drug Avandia remain on the market, even after finding that it raised the risks of heart attacks.Panel members said that studies concerning Avandia were too murky to merit drastic regulatory action and that other diabetes medicines might have similar risks.Source: http://www.nytimes.com/2007/07/31/health/ 31drug.html?hp
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Bisphosphonate induced Osteonecrosis of the Jaw [BONJ]
2007-07-28 09:06:00
Bisphosphonate associated osteonecrosis of the jaws (BONJ) has been well documented recently in relation to intravenous preparations of the drug. These are most commonly used as part of the management of hypercalcaemia of malignancy and metastatic bone disease but BONJ can also occur in association with oral bisphosphonate use. The oral preparations can also be prescribed in the management of metastatic bone disease but are more commonly used for the prevention and treatment of osteoporosis. Three case reports have been published in the British Dental Journal in which alendronate, risedronate and ibandronate have been associated with osteonecrosis of the jaws.The authors conclude, in agreement with other published authors, that prevention and early detection could be improved to reduce the occurrence and severity of this condition. However when BONJ is diagnosed, the early application of a closely monitored conservative regimen, with consideration given to discontinuation of the bis...
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Antidepressant induced Liver injury
2007-07-27 06:35:00
Antidepressant-induced liver injury described in published cases were of the idiopathic type and, by definition, cannot be predicted based on dose or specific risk factors. Paroxetine had the largest number of cases within the selective serotonin-reuptake inhibitor class. Nefazodone, a serotonin-norepinephrine reuptake inhibitor, appeared to have the most serious cases and is the only antidepressant agent that carries a Food and Drug Administration Black Box Warning regarding hepatotoxicity. The tricyclic antidepressants and monoamine oxidase inhibitors are capable of producing hepatotoxicity, but fewer cases with these agents have been reported in the past 15 years, possibly due to a decline in their use. Causality has not been well established in all reports due to the concurrent use of other drugs and/or underlying liver disease.Most antidepressant agents have the potential to produce idiopathic liver injury. There is no way to prevent idiopathic DILI, but the severity of the rea...
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Rabeprazole induced Neuropsychiatric Symptoms
2007-07-24 12:51:00
A case of a patient who developed marked anxiety associated with episodes of panic attacks after starting rabeprazole therapy has been reported in The Annals of Pharmacotherapy.An otherwise healthy 55-year-old woman was prescribed rabeprazole 20 mg/day administered in the morning for persistent symptoms of dyspepsia. Ten days later, she presented with a 7 day history of marked anxiety associated with panic attacks, night terror (pavor nocturnus), episodic mental confusion, and attention deficit. Within 2 days of discontinuing rabeprazole, the patient recovered completely from the neuropsychiatric manifestations. Subsequent esomeprazole therapy did not cause psychiatric symptoms.Source: http://www.theannals.com/cgi/content/abst ract/41/7/1315
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Elevation of LDL cholesterol concentration with Over the Counter Fish oil p
2007-07-24 12:48:00
A case of elevated low-density lipoprotein cholesterol (LDL-C) concentration in a patient taking fish oil supplements for hypertriglyceridemia has been reported in the Annals of Pharmacotherapy.A 63-year-old white woman had been taking 2.7 g of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) daily in 9 g of over-the-counter (OTC) fish oil capsules for triglyceride lowering. Prior to the adverse event, she had baseline fasting triglyceride (TG) and LDL-C concentrations of 278 mg/dL and 106 mg/dL, respectively. After 6 weeks of treatment with fish oil, fasting TG levels decreased by 47.5% (-132 mg/dL) and the LDL-C increased by 75% (+80 mg/dL). Discontinuation of therapy for 6 weeks resulted in TG returning to high concentrations (334 mg/dL; +56 mg/dL change from baseline) and LDL-C decreasing toward baseline (143 mg/dL; +37 mg/dL change from baseline).This case documents a much higher LDL-C elevation associated with OTC fish oil supplementation than has been previously ide...
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China stops sale of Methotrexate
2007-07-09 13:10:00
China's drug safety agency has suspended sales of Methotrexate, a drug used to treat acute leukemia and rheumatoid arthritis. Sale s of methotrexate produced by Shanghai Hualian Pharmaceutical Co. Ltd. have been suspended because it caused an adverse reaction in several child leukemia patients in three hospitals in Shanghai and the southern province of Guangxi.Some children felt pain in their legs while others experienced difficulty in walking after being injected with methotrexate numbered 070403A and 070403B.Source: Reutershttp://www.reuters.com/article/hea lthNews/idUSPEK1476920070707
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Ceftriaxone Sodium
2007-07-06 11:12:00
Roche and FDA informed healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections of the prescribing information for Rocephin for Injection. The revisions are based on new information that describes the potential risk associated with concomitant use of Rocephin with calcium or calcium containing solutions or products. Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys in both term and premature neonates were reported. Hyperbilirubinemic neonates, especially prematures, should not be treated with Rocephin. The drug must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines. Additionally, calcium-containing solutions or products must not be administered within 48-hours of the last administration of ceftriaxone.Source: FDA MedWatch July 5th 2007.http://www.fda.gov/medwatch/safety/2 007/safety07.ht...
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Unusual side effects with Acamprosate
2007-07-04 12:26:00
A case report of a subject reporting with Extra Pyramidal Symptoms after adminstration of Acamprosate for treatment of Alcohol dependence has been reported.Source: Indian J Psychiatry 2007;49:143.http://www.indianjpsychiatry. org/article.asp?issn=0019-5545;year=2007; volume=49;issue=2;spage=143;epage=143;aul ast=Sidana
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Escitalopram induced Mania
2007-07-04 12:18:00
A report of a case of recurrent depression with hypertension, ischemic heart disease and diabetes mellitus which switched to mania while on escitalopram. Escitalopram, one of the newer selective serotonin reuptake inhibitors (SSRIs), is considered to have fewer adverse effects and a lower propensity for drug interactions. However, escitalopram may induce mania at a maximum dose of 20 mg especially when given with Alprazolam which is known to boost efficacy of SSRIs.Source: Indian J Psychiatry 2007;49:121-122.http://www.indianjpsychia try.org/article.asp?issn=0019-5545;year=2 007;volume=49;issue=2;spage=121;epage=122 ;aulast=Parker
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Sanofi-Aventis Withdraws New Drug Application for Rimonabant
2007-07-03 19:20:00
Sanofi-aventis announced it would withdraw its new drug application for Zimulti (Rimonabant) after an FDA advisory committee recommended against approving the drug over concerns it increased the risk of suicide. The agency’s Endocrinological and Metabolic Drug s Advisory Committee voted unanimously that available safety data was insufficient to evaluate Zimulti’s (rimonabant) risk profile. The committee held the meeting over concerns of potential safety signals for psychiatric adverse events and suicidality. Sanofi-aventis also said it plans to submit an update of rimonabant’s safety data to the European Medicine’s Agency (EMEA) Committee for Medicinal Products for Human Use. The agency announced it will review data on psychiatric events as part of its continuous monitoring of the drug’s safety. The EMEA announced it would re-examine the drug after the FDA advisory committee voted against its approval. Source: American College of Clinical Pharmacology eNews group dated 3rd ...
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Piroxicam
2007-07-03 19:11:00
The European Medicines Agency (EMEA) has recommended restrictions on the use of piroxicam containing medicinal products because of the risk of gastrointestinal side effects and serious skin reactions. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that piroxicam should no longer be used for treatment of short-term painful and inflammatory conditions. Piroxicam can still be prescribed for the symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. However it should not be the first choice of non-steroidal anti-inflammatory drug (NSAID) treatment in these conditions.Prescription of piroxicam should always be initiated by a physician experienced in the treatment of patients with inflammatory or degenerative rheumatic diseases and treatment should be used in the lowest dose (no more than 20 mg per day) and for the shortest duration possible. In any case, the treatment should be reviewed after the first 14 days of starting.So...

Omalizumab
2007-07-03 19:09:00
Genetech and FDA informed healthcare professionals and asthmatic patients that the prescribing information for Xolair (Omalizumab) 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. In addition, a new MEDICATION GUIDE was developed and will be provided to patients when a prescription for Xolair is filled or refilled at the pharmacy. Due to the risk of anaphylaxis, Xolair should only be administered to patients in a healthcare setting under direct medical supervision. Patients should be observed for an appropriate period of time following each Xolair injection. Source: FDA MedWatch http://www.fda.gov/medwatch/safety/2007/s afety07.htm#Xolair
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Hypopigmentation associated with Imatinib Mesylate
2007-07-01 19:43:00
Three cases of hypopigmentation in patients of CML (Chronic Myelogenous Leukemia) being treated with Imatinib have been reported in Journal of Association of Physicians of India JAPI.Source and Detailed Report: JAPI 2007;55:527.http://www.japi.org/july2007/ Corr1.pdf
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Colistimethate
2007-07-01 12:29:00
FDA notified healthcare professionals and cystic fibrosis patients that the Agency is investigating the possible connection between the use of a liquid solution of Colistimethate that was premixed for inhalation with a nebulizer and the death of a patient with cystic fibrosis (CF). Colistimethate is FDA approved for intravenous or intramuscular injection for the treatment of acute or chronic infections due to sensitive strains of certain Gram-negative bacilli, particularly sensitive strains of Pseudomonas aeruginosa which are a significant problem for patients with CF and for patients with neutropenia, and/or immune system compromise. The product is not FDA approved for use as a liquid to be inhaled via nebulizer. In this case, the drug was prepared by a pharmacy and dispensed as prescribed in premixed unit dose ready-to-use vials. Once Colistimethate is mixed into a liquid form, the product breaks down into other chemicals that can damage lung tissue. Healthcare professionals who c...

Propofol
2007-07-01 12:27:00
FDA informed healthcare professionals about several clusters of patients who experienced chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia. Multiple vials and several lots of propofol used in patients who experienced these symptoms were tested and there was no evidence that the propofol vials or prefilled syringes used were contaminated with bacteria or endotoxins. Prop ofol is an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. To minimize the potential for bacterial contamination, propofol vials and prefilled syringes should be used within six hours of opening and one vial should be used for one patient only. Patients who develop fever, chills, body aches or other symptoms of acute febrile reactions shortly after receiving propofol should be evaluated for bacterial sepsis. Healthcare professionals who administer propofol for sedation or general anesthesia should carefully follow t...

FDA Updates RotaTeq Label
2007-06-22 20:18:00
The FDA has added information about Kawasaki disease to the label for the rotavirus vaccine (RotaTeq), but has not issued new warnings or precautions about the vaccine's use and maintains that it is safe. The updated label includes information about six cases of Kawasaki disease that occurred during the drug's clinical trials and three cases reported since the vaccine was licensed in February 2006. The number of cases reported is no greater than the number that would be expected by chance. There is no known cause-and-effect relationship between the vaccine and the disease.The FDA will monitor for additional cases of Kawasaki disease, but says that the vaccine is safe and effective and the "best way to protect a child against rotavirus disease."Source: Physician's First Watch June 18th 2007Detailed FDA report: http://www.fda.gov/cber/label/rotateqLBin fo.htm
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FDA Advisory Panel Rejects Obesity Drug
2007-06-22 14:17:00
An FDA advisory panel has voted unanimously not to recommend sale in the U.S. of rimonabant, a widely anticipated antiobesity drug, the New York Times reports.The drug, available in 37 countries, was rejected "because of worries that it causes neurological and psychiatric problems and increases the risk of suicide," according to the newspaper.Rimonabant is a cannabinoid-receptor blocker. In clinical studies, it had shown favorable effects not only on weight loss but also on fasting glucose, HDL cholesterol, and triglycerides.Source: Physician’s First Watch June 15th 2007Link: http://www.nytimes.com/2007/06/14/busines s/14drugs.html?ex=1182657600&en=1879e8c6b 01830c7&ei=5070
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