Pharmacovigilance

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Zanamivir
2008-04-13 10:50:00
GlaxoSmithKline informed healthcare professionals of changes to the WARNINGS AND PRECAUTIONS sections of prescribing information for Relenza regarding information from postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who are receiving neuraminidase inhibitors, including Relenza. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Relenza to these events has not been established. Influenza can be associated with a variety of neurologic and behavioral symptoms which can include seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits...

Exubera (insulin human rDNA origin) Inhalation Powder
2008-04-13 10:48:00
Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes. There have been 6 newly diagnosed cases of primary lung malignancies in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control. Source: http://www.fda.gov/medwatch/safety/2008/E xubera_DHCP.pdf
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Mycophenolate mofetil, Mycophenolate acid
2008-04-13 10:45:00
FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. PML is a rare disorder that affects the central nervous system usually occurring in patients with immune systems suppressed by disease or medicines. FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information. FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revisions to the prescribing info...
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Bortezomib
2008-03-28 06:09:00
The European Medicines Agency (EMEA) has recommended that Velcade (bortezomib) should not be used in patients with certain severe pulmonary or heart problems (acute diffuse infiltrative pulmonary and pericardial disease). Velcade is used to treat progressive multiple myeloma in patients who have failed to respond to at least one other treatment and who have already undergone or are unsuitable for bone marrow transplantation.Source: http://www.emea.europa.eu/humandocs/PDFs/ EPAR/velcade/Q&A_Velcade_13838708en.p df

Montelukast
2008-03-28 05:59:00
FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of Montelukast and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Montelukast is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking Montelukast before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking Montelukast for suicidality (suicidal thinking and behavior) and changes in behavior and mood. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and r...

Becaplermin Gel
2008-03-28 05:57:00
The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and benefits of using Regranex with their patients.This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. Source: http://www.fda.gov/cder/drug/early_comm/b ecaplermin.htm

Abacavir and Didanosine
2008-03-28 05:54:00
The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA’s review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking. This early communication is in keeping with FDA’s commitment to inform the public about its ongo...

Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoe
2008-03-17 16:28:00
Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL. Source: http://www.fda.gov/medwatch/safety/2008/e po_DHCP_03102008.pdf
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Darunavir
2008-03-17 16:26:00
FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of Prezista/ritonavir treatment. Source: http://www.fda.gov/medwatch/safety/2008/p rezista_DHCP.pdf

Denture Cleanser Allergic Reactions and Misuse
2008-03-05 10:34:00
FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers. These adverse events, including abdominal pain, vomiting, seizures, hypotension and difficulty breathing, have occurred both when the product has been used properly as well as from improper use. These events can occur soon after first use or after years of use. FDA believes that the ingredient responsible for these reactions is persulfate, a known allergen. Persulfates are used in most denture cleansers to help clean and bleach the dentures. FDA is recommending that all manufacturers of denture cleansers modify their labeling to include warning information that the product contains persulfates and recommends improving the directions for use on their labeling in order to reduce misuse.Source: http://www.fda.gov/cdrh/safety/022508-den turecleansers.html
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Natalizumab
2008-03-05 10:31:00
Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury. Source: http://www.fda.gov/medwatch/safety/2008/T ysabri_PI.pdf

Tamiflu (oseltamivir phosphate)
2008-03-05 10:28:00
Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu , in patients with influenza.The label has been revised as follows: Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving Tamiflu. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on Tamiflu usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution...

Gardasil
2008-02-10 06:18:00
The European Medicines Agency (EMEA) has received reports of deaths in women who hadpreviously received Gardasil , including two reports concerning the sudden and unexpected deaths of two young women in the European Union (EU). Gardasil is a vaccine approved in the EU for the prevention of cervical cancer and other diseases caused by human papillomavirus (HPV) types 6, 11, 16 and 18. It is estimated that about 1.5 million patients have been vaccinated with this HPV vaccine in Europe.The two European cases were reported as part of the continuous monitoring of the safety of medicines. One of the cases occurred in Austria and the other in Germany. In both cases, the cause of death could not be identified. No causal relationship has been established between the deaths of the young women and the administration of Gardasil.On the basis of the currently available evidence, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) is of the opinion that the benefits of Gardasil cont...

EMEA recommends new warnings and contraindications for rosiglitazone
2008-02-10 06:16:00
The European Medicines Agency (EMEA) has recommended updating the product information for rosiglitazone-containing antidiabetic medicines. Rosiglitazone is available in the European Union as Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin) and Avaglim (rosiglitazone maleate/glimepiride).During its January 2008 meeting, the Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a scientific opinion recommending the inclusion of a new warning stating that the use of rosiglitazone in patients with ischemic heart disease and/or peripheral arterial disease is not recommended.The CHMP also adopted an opinion recommending the addition of a new contraindication stating that rosiglitazone must not be used in patients with an acute coronary syndrome, such as angina or some types of myocardial infarction, because the medicine has not been studied in controlled trials in this specific patient group.Source: http://www.emea.europa.eu/pdfs/human/pres s/...
More About: Warnings

Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Ty
2008-02-10 06:12:00
FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic . FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. Source: http://www.fda.gov/cder/drug/early_comm/b otulinium_toxins.htm
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Injectable Colchicine (including drugs containing colchicine)
2008-02-10 06:10:00
FDA announced its intention to take enforcement action against companies marketing unapproved, injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure. This action does not affect colchicine products that are dispensed in tablet form. Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action. After these dates, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate. Source: http://www.fda.go...
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Enalaprilat Induced Acute Parotitis
2008-02-02 03:15:00
A case of Enalaprilat induced acute parotitis has been published in the latest issue of the Journal of Association of Physicians of India. A female patient developed acute bilateral parotitis within minutes of i.v. enalaprilat injection and recovered within 24 hours of stopping the drug and with symptomatic treatment.This adverse reaction was tested on Naranjo’s algorithm and a score of 8 was obtained which puts this reaction as probable in the algorithm.Reference: J Assoc Physc India 2008;56:128-129.Source: http://www.japi.org/february2008/CR-128.h tm

Antiepileptic Drugs
2008-02-02 03:09:00
FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions. Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that co...
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Varenicline
2008-02-02 03:06:00
FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy. Source: http://www.fda.gov/cder/drug/InfoSheets/H CP/vareniclineHCP.htmPublic Health Advisory

Ezetimibe/Simvastatin
2008-01-26 18:08:00
FDA provided healthcare professionals with an early communication about an ongoing data review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). This early communication is in keeping with FDA’s commitment to inform the public about ongoing postmarketing drug issues.Merck/Schering Plough Pharmaceuticals reported preliminary results from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial. This trial was designed to evaluate the amount of atherosclerotic plaque in blood vessels located in the neck based on images obtained through ultrasound in patients treated with Vytorin (ezetimibe plus simvastatin) or simvastatin alone. Merck/Schering Plough stated that there was no significant difference between Vytorin and simvastatin in the amount of atherosclerotic plaque in the inner wal...

Leukine (sargramostim)
2008-01-25 07:25:00
Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer. Source: http://www.fda.gov/medwatch/safety/2008/L eukine_DHCP_01-23-2008.pdf

Heparin Sodium Injection 1000 units/mL recalled due to multiple adverse rea
2008-01-21 06:21:00
Baxter Healthcare and FDA notified healthcare professionals of a voluntary recall of certain lots of Heparin as a precaution due to an increase in reports of adverse patient reactions associated with these lots. Baxter is in the process of an in-depth investigation to determine the root cause of the reported reactions. Reported adverse events include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. There have been no reports involving fatality. Source: http://www.fda.gov/medwatch/safety/2008/H eparin_recall_01-17-2008.pdf
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Ortho Evra Contraceptive Transdermal Patch
2008-01-21 06:08:00
FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for VTE.FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options. Source: http://www.fda.gov/bbs/topics/NEWS/2008/N E...

Cough and Cold Medications in Children Less Than Two Years of Age
2008-01-18 05:09:00
FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. Source: http://www.fda.gov/cder/drug/advisory/cou gh_cold_2008.htm
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Edetate Disodium (marketed as Endrate and generic products)
2008-01-17 06:03:00
FDA notified healthcare professionals and patients about important safety information concerning Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. Edetate Disodium was approved as an emergency treatment for certain patients with hypercalcemia (very high levels of calcium in the blood) or certain patients with heart rhythm problems as a result of very high amounts of digitalis in the blood. Edetate Calcium Disodium was approved to reduce dangerously high blood lead levels (severe lead poisoning). The two drugs have very similar names and are commonly referred to only as EDTA. As a result, the two products are easily mistaken for each other when prescribing, dispensing, and administering them. Edetate Disodium and Edetate Calcium Disodium w...
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Musculoskeletal Pain Associated with Bisphosphonate use
2008-01-09 13:07:00
FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown. Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculosk...
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Methotrexate-Induced Papular Eruption Following Treatment of Psoriasis
2008-01-09 12:59:00
A case of a 52-year-old woman presenting with an extensive flare of psoriasis associated with joint pain, especially in her knees and elbows on being treated with intramuscular injections of methotrexate 20 mg/wk has been published in the latest issue of The Annals of Pharmacotherapy. According to the Naranjo probability scale, the papular eruption was probably caused by methotrexate. The drug was discontinued and papular lesions gradually disappeared. Source: Annals of Pharmacotherapy 2007;42(1):138-141.http://www.theannals.c om/cgi/content/abstract/42/1/138
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Simultaneous Erythema Nodosum and Erythema Multiforme After Local Lidocaine
2008-01-09 12:55:00
A case of a 33-year-old female experiencing coexisting erythema nodosum and erythema multiforme after lidocaine spray whichwas used for upper gastrointestinal endoscopy has been published in the latest issue of The Annals of Pharmacotherapy. The reaction was exacerbated after localized injection of 2% lidocaine for a skin biopsy. An objective causality assessment revealed that an adverse drug reaction was highly probable. Source: Annals of Pharmacotherapy 2007;42(1):127-130.http://www.theannals.c om/cgi/content/abstract/42/1/127
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Clozapine-induced double incontinence
2008-01-04 08:29:00
A case of clozapine-induced double incontinence in a 23 years old male diagnosed with schizophrenia and started on clozapine 25 mg/day has been reported in the latest isuue of Indian Journal of Medical Sciences. On the Naranjo probability scale, the adverse drug reaction probability score for this patient to develop clozapine-induced double incontinence was nine, suggesting a definitive adverse reaction due to clozapine. Source: Indian J Med Sci 2007;61:665-6http://www.indianjmedsci.org /article.asp?issn=0019-5359;year=2007;vol ume=61;issue=12;spage=665;epage=666;aulas t=Mendhekar
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Gabapentin Induced Hypersensitivity Syndrome
2007-12-28 12:28:00
Hypersensitivity syndrome (HSS) is a rare condition that can occur with any drug. Diagnosis is clinically based, with variable symptoms appearing anywhere between one week to three months after the introduction of the implicated drug. A case of HSS due to gabapentin in a 35 years old lady has been published in the Journal of Postgraduate Medicine.Naranjo's algorithm, a systematic method of objectively determining the probability of adverse drug reaction having occurred, was applied to this case. A score of 6 was calculated, equating to a "probable" adverse reaction to gabapentin.Source: J Postgrad Med 2007;53:276-7http://www.jpgmonline.com/te xt.asp?2007/53/4/276/37527
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