Topical Anesthetics

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

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

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

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

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

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

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

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

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

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)

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

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

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