Gabapentin Induced Hypersensitivity Syndrome

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;53:276-7

http://www.jpgmonline.com/text.asp?2007/53/4/276/37527

Risedronate induced transient ocular myasthenia

A case of ocular myasthenia gravis induced by risedronate therapy for osteoporosis in a 81 years old lady has been reported in The Journal of Postgraduate Medicine.

On Applying the Naranjo's adverse drug reactions (ADR) probability scale, a causality assessment was made which categorized this reaction as probable with a score of 7.

Source: J Postgrad Med 2007;53:274-5

http://www.jpgmonline.com/text.asp?2007/53/4/274/37525

Drug rash with eosinophilia and systemic symptoms syndrome due to quinine

A case of a 58 years old male patient with drug rash with eosinophilia and systemic symptoms (DRESS) syndrome due to quinine has been published in the Journal of Postgraduate Medicine.

On Naranjo scale it scored 5, classifying it as a probable adverse drug reaction.

Source: J Postgrad Med 2007;53:272-3

http://www.jpgmonline.com/text.asp?2007/53/4/272/37523

Tobramycin induced Hepatotoxicity

A case of a hepatotoxicity occuring as a result of tobramycin adminstration has been published in the December issue of the Annals of Pharmacotherapy.
Liver enzymes rose when tobramycin therapy was initiated, markedly increased when the tobramycin dose was increased, then resolved upon discontinuation of therapy. Other medication-related causes were ruled out by temporal relationship or rechallenge (aztreonam). Use of the Naranjo probability scale indicated a possible relationship between hepatotoxicity and tobramycin therapy. Other adverse reaction scales specific for evaluation of drug-induced liver disease were also used. Both the Council for International Organizations of Medical Sciences and Maria and Victorino scales indicated a probable likelihood of tobramycin-induced hepatotoxicity.

Reference: The Annals of Pharmacotherapy 2007;41(12): 2061-2065.

http://www.theannals.com/cgi/content/abstract/41/12/2061

Lumiracoxib

The European Medicines Agency (EMEA) has recommended the withdrawal of the marketing authorisations for all lumiracoxib-containing medicines, because of the risk of serious side effects affecting the liver. Lumiracoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group ‘COX-2 inhibitors’. It is used for symptomatic relief in the treatment of osteoarthritis of the hip and knee.

Source: http://www.emea.europa.eu/pdfs/human/press/pr/PR_Lumiracoxib_57930107en.pdf

Carbamazepine

FDA informed healthcare professionals that dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from areas in which HLA-B*1502 is present should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine. If these individuals test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is true for patients of any ethnicity or genotype, including patients positive for HLA-B*1502.

Source: http://www.fda.gov/cder/drug/InfoSheets/HCP/carbamazepineHCP.htm

Radio Frequency Ablation Devices

FDA alerted healthcare professionals of reports of patient deaths associated with the use of radio frequency (RF) ablation devices during lung tumor ablation. Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities. While RF ablation devices have been cleared for general indications- ablation of soft tissue by thermal coagulation necrosis- the devices have not been cleared specifically for lung tumor ablation. Healthcare professionals should use caution when operating RF ablation devices, adhering strictly to information contained in the labeled operating instructions, Operators Manual, the Manufacturer's Instructions for Use and any training provided. Additionally, if healthcare professionals plan to use RF ablation devices to treat patients with lung tumors, they should consider enrolling patients in an approved clinical study, where training is available.

Source: http://www.fda.gov/cdrh/safety/121107-rfablation.html

Electric Dental Handpieces

FDA informed healthcare professionals about serious patient injuries, including third degree burns, associated with the use of poorly maintained electric dental handpieces during dental procedures. Some patients had third degree burns which required plastic surgery. Burns may not be apparent to the operator or the patient until after the tissue damage occurred, because the anesthetized patient cannot feel the tissue burning and the handpiece housing insulates the operator from the heated attachment. Although the reported burns occurred during the cutting of tooth and bone, tooth extraction and other dental surgical procedures, overheating can also occur during any dental procedure. This problem is not limited to dentistry. Rotary surgical handpieces can cause patient burns during orthopedic procedures, as reported in the July 2003 edition of FDA Patient Safety News (http://www.fda.gov/cdrh/psn/show17-burns.html). Read the FDA Public Health Notification for specific actions to prevent or minimize serious patient injuries associated with using electric dental handpieces.

Source: http://www.fda.gov/cdrh/safety/121207-dental.html

PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] COMVAX [Haemophilus b Conjugate (Menigococcal Protein Conjugate)

Merck & Co. and FDA informed healthcare professionals and consumers of a voluntary recall of eleven lots of PedvaxHIB and two lots of COMVAX vaccines. The vaccines were recalled because the manufacturer cannot assure sterility of the affected lots. Routine testing of the vaccine manufacturing equipment used to produce PedvaxHIB and COMVAX identified the presence of Bacillus cereus bacteria. Sterility tests of the vaccine lots themselves have not found any contamination. The affected doses were distributed in the U.S. starting in April 2007. Healthcare professionals should immediately discontinue use of any of the affected lots and follow the manufacturer's instructions for returning recalled vaccines. See the FDA Consumer Update (link given below) for a list of the specific lots of each vaccine recalled.

Source: http://www.fda.gov/consumer/updates/hib121307.html

Cardiac Risks associated with Omeprazole

FDA informed healthcare professionals of the issuance of the Agency's follow-up communication regarding its review of safety data for the drugs omeprazole and esomeprazole that raised concerns about a potential increased risk of heart problems for patients treated with these drugs. The Agency conducted a comprehensive review of the data from two studies that were submitted to FDA. FDA continues to believe that long-term use of omeprazole or esomeprazole is not likely to be associated with an increased risk of heart problems and recommends that healthcare providers continue to prescribe and patients continue to use these products in the manner described in the labeling for the two products.

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