The number of Serious Adverse Events doubles in seven years in the US

The number of reported serious adverse events from drug treatment more than doubled in the United States from 1998 to 2005, rising from 34,966 to 89,842.

Over the same period the number of deaths relating to drugs nearly tripled, from 5519 to 15 107, show data from the US Food and Drug Administration's adverse event reporting system, which collects all reports of adverse events submitted voluntarily to the agency either directly or through drug manufacturers.

Source: Archives of Internal Medicine 2007;167:1752-9.

BMJ 2007;335:585 (22 September), doi:10.1136/bmj.39339.624711.DB

http://www.bmj.com/cgi/content/extract/335/7620/585-a

Oral Aloe Vera induced Hepatitis

A case of a 73-year-old female admitted to the hospital for acute hepatitis has been published in the Annals of Pharmacotherapy. Extensive laboratory testing did not reveal the cause of the patient's disease. She was asked multiple times whether she was taking any home medications, which she initially denied. It was only after an extensive medication history done by a clinical pharmacist that the patient admitted to using oral aloe vera capsules for constipation. Upon discontinuation of the oral aloe vera, liver markers of hepatotoxicity returned to normal levels.

Using the Roussel Uclaf Causality Assessment Method for determining drug hepatotoxicity, the patient's symptoms were scored as probably caused by oral aloe vera.

Source: The Annals of Pharmacotherapy 2007;41(10):1740-1743.

http://www.theannals.com/cgi/content/abstract/41/10/1740

Visual Loss associated with Povidone-Iodine Pleurodesis

Three cases of bilateral severe loss of vision (ranging from 20/800 vision to the perception of hand motions only) after thoracoscopic surgery involving resection of parts of one lung and instillation of 200 to 500 ml of Jodobac, a 10% povidone–iodine solution, into the thoracic cavity for disinfection and to cause scarring of the pleura for prophylaxis against pneumothorax have been reported in the latest issue of the New England Journal Of Medicine.

Source: NEJM 2007;357(12):1264-65.

http://content.nejm.org/cgi/content/full/357/12/1264

Aplastic Anemia associated with Temozolomide

A safety review of temozolomide identified cases of aplastic anemia, some fatal, associated with use of the drug. Healthcare professionals should be alert to the possibility of aplastic anemia in the setting of refractory or prolonged myelosuppression in patients receiving temozolomide and report cases to FDA's MedWatch.

From August 11, 1999, to November 3, 2006, FDA received 18 (domestic-14, foreign-4) reports of aplastic anemia among patients receiving temozolomide. Product labeling currently includes a warning regarding myelosuppression and describes pancytopenia among reported adverse events.

Source: http://www.fda.gov/cder/dsn/2007_fall/postmarketing.htm#Temozolomide

Serious Skin Reactions Associated with Modafinil

Modafinil (Provigil) is an oral wakefulness-promoting agent to treat patients with excessive sleepiness (ES) associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep disorder (SWSD).

FDA has been monitoring cases of serious skin reactions, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), in its postmarketing reviews of adverse event reports associated with the use of modafinil. The product labeling for modafinil has been recently updated to include a bolded warning for serious rash, including SJS.

Source: http://www.fda.gov/cder/dsn/2007_fall/postmarketing.htm#modafinil

Progressive Multifocal Leukoencephalopathy (PML) associated with Rituximab

A safety review on rituximab identified an association of the drug with a serious adverse event, progressive multifocal leukoencephalopathy (PML), a viral infection of the central nervous system. The product labeling has been updated to reflect this new safety information, and a public health advisory and information for healthcare professionals have been posted on FDA's Web site.
As of December 2006, FDA has received a total of 24 reports of PML in patients who received rituximab treatment.

Source: http://www.fda.gov/cder/dsn/2007_fall/postmarketing.htm#Rituximab

Cardiovascular Risk with Haloperidol

Johnson and Johnson and FDA informed healthcare professionals that the WARNINGS section of the prescribing information for haloperidol has been revised to include a new Cardiovascular subsection regarding cases of sudden death, QT prolongation and Torsades de Pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. Although injectable haloperidol is only approved by the FDA for intramuscular injection, there is considerable evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice.

There are at least 28 case reports of QT prolongation and TdP, some with fatal outcome in the context of off-label intravenous haloperidol. Healthcare professionals should consider this new risk information when making individual treatment decisions for their patients.

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

Potential Risk Associated With Concomitant Use Of Ceftriaxone With Calcium Containing Products

Roche informed healthcare professionals about revisions made to the prescribing information for Rocephin (Ceftriaxone Sodium) to clarify the potential risk associated with concomitant use of Rocephin with calcium or calcium-containing solutions or products.

Healthcare professionals are advised that Rocephin and calcium-containing solutions including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites. Rocephin and IV calcium-containing solutions should not be administered within 48 hours of each other in any patient. No data are available on the potential interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).

Source: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rocephin

valproate-induced hyperammonemic encephalopathy

A case of valproate-induced hyperammonemic encephalopathy in a 18 years old female being prescribed valproate 750mg per day for temporal lobe epilepsy and having normal liver function has been published in Canadian Medical Association Journal.

Source: CMAJ. September 11, 2007; 177 (6). doi:10.1503/cmaj.061272.

http://www.cmaj.ca/cgi/content/full/177/6/568

Viracept (nelfinavir mesylate) and guidance on use in pregnant women and pediatric patients

Pfizer issued a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate (EMS), a process-related impurity in Viracept and to provide guidance on the useof Viracept in pregnant women and pediatric patients.

EMS is a potential human carcinogen. Data from animal studies indicate EMS is teratogenic, mutagenic and carcinogenic; however, no data from humans exist. FDA has asked Pfizer to implement new specifications to limit the presence ofEMS in Pfizer-manufactured Viracept products marked in the UnitedStates.

For pediatric patients who are stable on Viracept-containing regimens, FDA and Pfizer agree that the benefit-risk ratio remains favorable and those patients may continue to receive Viracept. Pediatric patients who need to begin HIV treatment should not start regimens containingViracept until further notice. Pregnant women who need to begin antiretroviral therapy should not be offered regimens containingViracept until further notice. As a precautionary measure, pregnant women currently receiving Viracept should be switched to an alternative antiretroviral therapy while Pfizer and FDA work to implement the longterm EMS specification for Viracept. For pregnant women with no alternative treatment options, FDA and Pfizer agree that therisk-benefit ratio remains favorable for the continued use of Viracept.

Source: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Viracept

Acute hepatitis attack after exposure to telithromycin

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.clinicaltherapeutics.com/articles/1725_onu.pdf

High-Dose Prexige (Lumiracoxib) Withdrawn in New Zealand

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