Pharmacovigilance

APLASTIC ANEMIA FOLLOWING VARICELLA VACCINE.

2009-07-29T09:46:00.000+05:30

A Publication in the Pediatrics Infectious Diseases Journal describe an immunocompetent child who developed transient severe aplastic anemia concomitant with a typical clinical and laboratory-proven chickenpox syndrome 3 weeks after immunization. A causative association between the vaccine and the hematologic disease is possible, and pediatricians should be aware of this severe although rare adverse event.

Reference: Pediatr Infect Dis J. 2009 Aug;28(8):746-748.

Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use

2009-03-22T13:43:00.001+05:30

The FDA notified healthcare providers and patients that insulin pens and insulin cartridges are never to be shared among patients. Sharing of insulin pens may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user. The FDA is working with the Centers for Disease Control and Prevention, professional societies and healthcare organizations to reinforce patient and healthcare provider education about proper and safe use of insulin pens.
Source: http://www.fda.gov/cder/drug/InfoSheets/HCP/insulin_pensHCP.htm

Transdermal Drug Patches with Metallic Backings

2009-03-22T13:41:00.000+05:30

FDA notified healthcare professionals and patients that certain transdermal patches (medicated patches applied to the skin), containing aluminum or other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch. FDA is in the process of reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan. Until this review is complete, FDA recommends that healthcare professionals referring patients to have an MRI scan identify those patients who are wearing a patch before the patients have the MRI scan. The healthcare professional should advise these patients about the procedures for removing and disposing of the patch before the MRI scan, and replacing the patch after the MRI scan. MRI facilities should follow published safe practice recommendations concerning patients who are wearing patches.
FDA has evaluated the composition of available patches to determine which of them contain metal components and to assure that this information is included in their labeling. Based on current information from this evaluation, FDA is working with the manufacturers of the following patches to update the labeling to include adequate warnings to patients about the risk of burns to the skin if the patch is worn during an MRI scan. It should be noted that some of the drugs listed may have a generic equivalent and more than one size and strength of patch.
Source: http://www.fda.gov/cder/drug/advisory/transdermalpatch.htm

Metoclopramide-Containing Drugs

2009-03-22T13:40:00.000+05:30

FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment. Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. Manufacturers will be required to implement a risk evaluation and mitigation strategy [REMS] to ensure patients are provided with a medication guide that discusses this risk. Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment.
Source: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01963.html

Zonisamide

2009-03-22T13:39:00.000+05:30

FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk for developing metabolic acidosis and the risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in younger patients. FDA recommends that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with zonisamide, even in the absence of symptoms and is working with the makers of zonisamide to revise the product labeling to reflect this new safety information. The notification includes recommendations for healthcare providers, information for patients, and a data summary.
Source: http://www.fda.gov/cder/drug/InfoSheets/HCP/zonisamideHCP.htm

Raptiva (efalizumab)

2009-03-22T13:37:00.001+05:30

FDA issued a Public Health Advisory to notify healthcare professionals of three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva. In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva. The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML. The Public Health Advisory provides recommendations for healthcare providers and patients when treatment with this product is considered.
Source: http://www.fda.gov/cder/drug/advisory/efalizumab.htm

Xigris (Drotrecogin alfa [activated])

2009-03-22T13:35:00.000+05:30

FDA is aware of a recently published study, a retrospective medical record review of 73 patients who receive Drotrecogin alfa (activated), marketed as Xigris, indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (Gentry et al.; Crit Care Med 2009).The study reported an increased risk of serious bleeding events and of death in patients with sepsis and baseline bleeding risk factors who received this product. Serious bleeding events occurred in 7 of 20 patients (35%) who had a bleeding risk factor vs. only 2 of 53 (3.8%) patients without any bleeding risk factors. The finding by Gentry et al. of an increased risk of death and serious bleeding events in patients treated with Xigris who also have baseline bleeding risk factors is consistent with the information in the current product label. Prescribers should refer to the product label for the specific contraindications, warnings, and, precautions and carefully weigh the increased risk of bleeding against the benefits of Xigris. FDA is working with the manufacturer to further evaluate the incidence of serious bleeding events and mortality in patients who received Xigris. FDA will communicate its conclusions and any resulting recommendations to the public when the review is completed, which may take several months.The FDA urges both healthcare professionals and patients to report side effects from the use of Xigris to the FDA's MedWatch Adverse Event Reporting program.
Source: http://www.fda.gov/cder/drug/early_comm/drotrecogin_alfa.html

Clopidogrel bisulfate

2009-03-22T13:30:00.001+05:30

FDA notified healthcare professionals that the makers of Plavix have agreed to work with FDA to conduct studies to obtain additional information that will allow a better understanding and characterization of the effects of genetic factors and other drugs (especially the proton pump inhibitors (PPIs)) on the effectiveness of clopidogrel. FDA is aware of published reports that clopidogrel (marketed as Plavix) is less effective in some patients than it is in others. Differences in effectiveness may be due to genetic differences in the way the body metabolizes clopidogrel or that using certain other drugs with clopidogrel can interfere with how the body metabolizes clopidogrel. These studies should lead to a better understanding about how to optimize the use of clopidogrel. The FDA recognizes the importance of obtaining these data promptly. The drug manufacturers have agreed to a timeline for completing the studies and FDA will review the new information expeditiously and will communicate its conclusions and any recommendations to the public at that time. It could take several months to complete the studies and analyze the results. Until further information is available FDA recommends the following:
• Healthcare providers should continue to prescribe and patients should continue to take clopidogrel as directed, because clopidogrel has demonstrated benefits in preventing blood clots that could lead to a heart attack or stroke.
• Healthcare providers should re-evaluate the need for starting or continuing treatment with a PPI, including Prilosec OTC, in patients taking clopidogrel.
• Patients taking clopidogrel should consult with their healthcare provider if they are currently taking or considering taking a PPI, including Prilosec OTC.

Source: http://www.fda.gov/cder/drug/early_comm/clopidogrel_bisulfate.htm

Convulsions with propofol

2009-03-02T17:43:00.002+05:30

A case report of convulsions after propofol administration has been published in Journal of Postgraduate Medicine.
Reference Article: J Postgrad Med 2009;55:69-71
Source: http://www.jpgmonline.com/text.asp?2009/55/1/69/48444

Rifampicin-Induced Thrombocytopenia

2009-03-02T17:39:00.003+05:30

A case of Rifampicin-Induced Thrombocytopenia in a 32 year old lady has been published in Journal of Association of Physicians of India
Reference Article: JAPI 2009;57:213.
Source: http://www.japi.org/march_2009/PC-1.html

Topical Anesthetics

2009-01-26T08:51:00.000+05:30

FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from mammography and other medical tests and conditions. FDA is concerned about the potential for these products to cause serious, life-threatening adverse effects, such as irregular heartbeat, seizures, breathing difficulties, coma and even death, when applied to a large area of skin or when the area of application is covered. FDA is working with healthcare professional organizations and other media that distribute healthcare information to spread the message about the potential hazards and safe use of topical anesthetics.
Source: http://www.fda.gov/cder/drug/advisory/topical_anesthetics2009.htm

Rhabdomyolysis Due to an Uncommon Interaction of Ciprofloxacin with Simvastatin

2009-01-18T16:49:00.002+05:30

A case report of a ciprofloxacin and simvastatin interaction has been published in the latest issue of Canadian Journal of Clinical Pharmacology. The addition of ciprofloxacin to chronic simvastatin therapy led to the development of rhabdomyolysis.
Reference: Can J Clin Pharmacol Vol 16 (1) Winter 2009:e78-e79; January 16, 2009
Source: http://www.cjcp.ca/hm/index.php?id=707

Prolonged intrahepatic cholestasis after Loxoprofen exposure

2009-01-18T16:41:00.001+05:30

A case of Prolonged intrahepatic cholestasis after Loxoprofen exposure has been published in the latest issue of Clinical Therapeutics
Reference: Clin Ther 2008;30:2402-2406
Source: http://clinicaltherapeutics.com/current.html

Esophageal Cancer with Oral Bisphosphonate use

2009-01-03T18:43:00.003+05:30

A series of cases of Esophageal cancer with alendronate as the suspect drug has been published in the latest issue of The New England Journal of Medicine.
Reference: NEJM 2009; 360(1):89-90.
Source: http://content.nejm.org/cgi/content/full/360/1/89

Isoniazid Toxicity Presenting As Status Epilepticus and Severe Metabolic Acidosis

2009-01-03T18:33:00.002+05:30

A case of Isoniazid Toxicity Presenting As Status Epilepticus and Severe Metabolic Acidosis has been published in the latest issue of Journal of Association of Physicians of India.
Reference: JAPI 2009;57:70-71.
Source: http://www.japi.org/january_2009/C-2.pdf

A Probable Case of Oral Bisphosphonate-Associated Osteonecrosis of the Jaw

2009-01-03T18:24:00.002+05:30

A Probable Case of Oral Bisphosphonate-Associated Osteonecrosis of the Jaw and Recovery with Parathyroid Hormone Treatment has been published in Current Therapeutic Research.
Reference: Current Therapeutic Research 2008;69(4):356-362.
Source: http://www.currenttherapeuticres.com/current.html

Varenicline-Associated Acute Renal Failure

2009-01-03T18:20:00.002+05:30

A case highlighting the association between acute renal failure and varenicline has been published in the latest issue of The Annals of Pharmacotherapy.
Reference: The Annals of Pharmacotherapy: Vol. 42, No. 12, pp. 1908-1911.
Source: http://www.theannals.com/cgi/content/abstract/42/12/1908

Cushing's Syndrome Induced by Misuse of Moderate- to High-Potency Topical Corticosteroids

2009-01-03T18:17:00.002+05:30

A case of Cushing's syndrome caused by continuous use of moderate- to high-potency topical corticosteroids over several months has been reported in the latest issue of Annals of Pharmacotherapy.
Reference: The Annals of Pharmacotherapy: Vol. 42, No. 12, pp. 1903-1907.
Source: http://www.theannals.com/cgi/content/abstract/42/12/1903

Rash Associated with Pregabalin Use

2009-01-03T18:14:00.002+05:30

A case of extensive rash induced by orally administered pregabalin in a patient with neuropathic pain has been published in the latest issue of The Annals of Pharmacotherapy.
Reference: The Annals of Pharmacotherapy: Vol. 42, No. 12, pp. 1899-1902.
Source: http://www.theannals.com/cgi/content/abstract/42/12/1899

Syndrome of Inappropriate Secretion of Antidiuretic Hormone Associated with Imatinib

2009-01-03T18:09:00.002+05:30

A case of SIADH assocaited with Imatinib use has been reported in the latest issue of Annals of Pharmacotherapy
Reference: The Annals of Pharmacotherapy: Vol. 42, No. 12, pp. 1882-1886.
Source: http://www.theannals.com/cgi/content/abstract/42/12/1882

Innohep (tinzaparin sodium injection)

2009-01-03T18:06:00.001+05:30

Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to Innohep when treating these patients for deep vein thrombosis with or without pulmonary embolism.
FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed. In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.

Source: http://www.fda.gov/medwatch/safety/2008/Celgene_Innohep_DHCP_Letter.pdf

Ciprofloxacin induced nightmares

2009-01-01T08:09:00.002+05:30

A case of ciprofloxacin induced nightmares in an adult patient has been published in Indian Journal of Psychiatry.
Reference: Indian J Psychiatry 2008;50(4):305-306.
Source: http://www.indianjpsychiatry.org/text.asp?2008/50/4/305/44757

Weight Loss Pills

2009-01-01T08:07:00.000+05:30

FDA alerted consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. The undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant ( a drug not approved for marketing in the United States), phenytoin ( an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). The weight loss products, some of which are marked as "dietary supplements," are promoted and sold on various web sites and in some retail stores.
FDA advises consumers who use the products to stop taking them and consult their healthcare professional immediately as the health risks posed by these products can be serious (for example, high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke). FDA also encourages consumers to seek guidance from healthcare professional before purchasing weight loss products. See the FDA News Release for a listing of the names of the 25 referenced products.

Source: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html

Olanzapine induced Tardive Dystonia

2008-11-28T15:39:00.002+05:30

A case of a 32 years old male suffering from Olanzapine induced tardive dystonia has been reported in Indian Journal of Pharmacology.
Reference: Indian J Pharmacol 2008;40:237-8
Source: http://www.ijp-online.com/text.asp?2008/40/5/237/44158

Quetiapine induced myoclonus

2008-11-28T15:34:00.001+05:30

Cases of 2 young females who developed myoclonic jerks while on quetiapine have been reported in Indian Journal of Medical Sciences.
Reference: Indian J Med Sci 2008;62:422-3
Source: http://www.indianjmedsci.org/text.asp?2008/62/10/422/44024