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Prescriber Update Vol.36 No.1 March 2015

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Prescriber Update Vol.36 No.1 March 2015 Prescriber Update Vol. 36 No. 1 March 2015 www.medsafe.govt.nz ISSN 1172-5648 (print) ISSN 1179-075X (online) Contents A Topical Issue – Serious Hypersensitivity and Burning Reactions 2 Atomoxetine and Raynaud’s Phenomenon 3 Check INR after Starting Roxithromycin for Patients on Warfarin 3 Fruit Interactions with Common Medicines 4 Sexual Dysfunction Associated with Antidepressants and Antipsychotics 5 Rotavirus Vaccination – Summary of Adverse Event Reports Received in the First Six Months of Funding 8 MARC’s Remarks: December 2014 Meeting 8 Risk of Stroke with Ranibizumab (Lucentis), Bevacizumab (Avastin) and Aflibercept (Eylea), Administered by Intravitreal Injection 9 Medicine Labels – Rubbing Salt into the Wound 10 Domperidone – At the Heart of the Matter 10 Adverse Reaction Reporting in New Zealand – 2014 12 Spontaneous Reports: Seasonal Influenza Vaccination 2014 13 MEDICINES MONITORING 13 Preventing Paediatric Medication Errors 14 A Topical Issue — Serious Hypersensitivity and Burning Reactions There have been reports internationally Key Messages of chemical skin burns in premature neonates who were treated with chlorhexidine solution z Serious hypersensitivity reactions before central venous catheterisation3. This risk including anaphylaxis have been reported has been associated with both alcohol-based and following the use of topical acne products water-based solutions. that contain benzoyl peroxide or salicylic acid. According to these reports and the published literature, the risk appears to be higher z There is a risk of chemical skin burns with in premature neonates, especially those born the use of chlorhexidine solution for skin before 32 weeks of gestation and within the first disinfection in premature neonates. two weeks of life. To reduce the risk of chemical skin burns, use Topical acne products containing benzoyl the minimum amount of chlorhexidine solution peroxide or salicylic acid required and do not allow the solution to pool Benzoyl peroxide and salicylic acid are used in in skin folds or under the patient. Remove any topical acne products available from pharmacies, excess solution and any soaked materials from the supermarkets and other retail stores. These skin. Monitor patients frequently to ensure that products include gels, creams and face washes. cutaneous side effects are detected and managed Local skin irritation reactions such as redness, at an early stage3. burning, dryness, itching, peeling, or slight There have also been reports of severe allergic swelling are known to occur particularly with reactions including anaphylaxis following benzoyl peroxide1. Serious hypersensitivity chlorhexidine use. Medsafe has previously reactions including anaphylaxis have also been notified healthcare professionals of this risk reported following the use of these topical acne (www.medsafe.govt.nz/profs/PUArticles/ products2. June2013Chlorhexidine.htm). The Centre for Adverse Reactions Monitoring (CARM) has received reports of angioedema, References 1. Galderma Australia Pty Ltd. 2011. Benzac AC Gel consumer periorbital oedema, bronchospasm and syncope medicine information. 4 August 2011. URL: www. with the use of topical acne products that contain medsafe.govt.nz/consumers/cmi/b/benzacACgel.pdf benzoyl peroxide or salicylic acid. (accessed 7 January 2015). 2. The Food and Drug Administration. 2014. FDA warns Consumers should be advised to stop using these of rare but serious hypersensitivity reactions with products and to seek emergency medical attention certain over-the-counter topical acne products. Drug immediately if they experience throat tightness, Safety Communications 25 June 2014. URL: www.fda. gov/Drugs/DrugSafety/ucm400923.htm (accessed 7 difficulty breathing, feeling faint, or swelling of January 2015). the eyes, face, lips or tongue. These are symptoms 3. Medicines and Healthcare products Regulatory Agency. of a serious hypersensitivity reaction. 2014. Chlorhexidine solutions: risk of chemical burn injury to skin in premature infants. Drug Safety Update June 2014. URL: www.mhra.gov.uk/home/groups/dsu/ Use of chlorhexidine in premature neonates documents/publication/con428334.pdf (accessed 7 Chlorhexidine solution is used as a January 2015). skin disinfectant prior to invasive procedures in neonates. It is available in both alcohol-based and water-based solutions. 2 Prescriber Update 2015; 36(1) March Atomoxetine and Raynaud’s Phenomenon Disorder (ADHD) in adults and children six Key Messages years of age and older1. Raynaud’s phenomenon z Raynaud’s phenomenon is a very is a reversible vasospasm in parts of the rare (<0.1%) reaction associated with hand in response to cold, emotional stress or atomoxetine. vibration2. Symptoms of Raynaud’s phenomenon include sensations of coldness, burning pain, z Patients should be encouraged to seek paraesthesias or intermittent colour changes of medical attention if they experience one or more digits. If left untreated, Raynaud’s symptoms in their hands including phenomenon may result in tissue loss or digital sensations of coldness, burning pain, gangrene2. paraesthesias or intermittent colour changes of one or more digits. The primary treatments for Raynaud’s phenomenon are to avoid cold and other triggers. z If Raynaud’s phenomenon is diagnosed Medical treatment may include calcium channel then atomoxetine treatment may need to blockers for vasodilation. be withdrawn. Healthcare professionals should advise patients The Centre for Adverse Reactions Monitoring and caregivers to seek medical attention if they (CARM) has received a report of Raynaud’s experience symptoms of Raynaud’s phenomenon phenomenon in a very young patient who was in the first few months after starting atomoxetine. being treated with atomoxetine. The patient Please report all suspicions of medicine adverse exhibited severe Raynaud’s phenomenon that reactions to CARM. resolved as soon as atomoxetine was discontinued. This case report highlights a rare reaction to References atomoxetine which can be extremely painful for 1. Eli Lilly and Company (NZ) Limited. 2013. Strattera patients. The association between atomoxetine Data Sheet. 6 August 2013. URL: www.medsafe.govt. nz/profs/datasheet/s/Stratteracap.pdf (accessed 12 and Raynaud’s phenomenon is listed as very rare January 2015). 1 (<0.1%) in the data sheet . 2. Merck Manual Online. 2014. Raynaud Syndrome. URL: http://www.merckmanuals.com/ Atomoxetine is a non-stimulant treatment professional/cardiovascular_disorders/ indicated for Attention-Deficit/Hyperactivity peripheral_arterial_disorders/raynaud_syndrome. html?qt=raynaud&alt=sh (accessed 12 January 2015). Check INR after Starting Roxithromycin for Patients on Warfarin In the reports received by the Centre for Adverse Key message Reactions Monitoring (CARM), roxithromycin z Prescribers should monitor the INR three accounted for 44% of the adverse event reports days after (on day three) starting some of increased INR in patients taking antibiotics antibiotics in patients taking warfarin. and warfarin. The occurrence of an increased INR in association with the roxithromycin- Some antibiotics can interact with warfarin which warfarin combination was noted in a previous can increase the international normalised ratio article of Prescriber Update (www.medsafe.govt. (INR) and cause severe bleeding. nz/profs/PUArticles/watchingbriefsMay08. htm#Roxithromycin). Roxithromycin was recently associated with a bleeding episode in a patient taking warfarin for In a recent observational study, 3.2% of patients atrial fibrillation. The patient (whose INR had taking warfarin and an antibiotic experienced an been between 2 and 3) complained of abdominal INR of 5.0 or more1. pain three days after starting roxithromycin. An In contrast, rifampicin markedly reduces the abdominal bleed was diagnosed and the INR was anticoagulant effect of warfarin2. found to be greater than 7. Prescriber Update 2015; 36(1) March 3 Prescribers should monitor the INR three days from the intestine. Fever itself may increase the after (on day three)3 starting the following catabolism of clotting factors and exaggerate a antibiotics: potential antibacterial-warfarin interaction1, 4. macrolides (erythromycin, azithromycin, Please report all suspicions of medicine clarithromycin, roxithromycin) interactions to CARM. fluoroquinolones (nalidixic acid and References ciprofloxacin) 1. Clark NP, Delate T, Riggs CS, et al. Warfarin-Associated Research Projects and Other Endeavors Consortium. selected cephalosporins (eg, cefamandole) 2014. Warfarin interactions with antibiotics in co-trimoxazole. the ambulatory care setting. JAMA Internal Medicine. 174(3): 409–16. The mechanism of the interaction is not fully 2. Stockley IH. 2002. Stockley’s Drug Interactions. London: understood but may include inhibition of Pharmaceutical Press. cytochrome P450, displacement of protein-bound 3. Bryant L, Fishman T, et al. 2009. Drug interactions that matter and how to manage them. Journal of Primary warfarin, interference with platelet function, and Health Care 1(2). the elimination of vitamin-K producing bacteria 4. Sweetman SC (ed) 2011. Martindale: The Complete Drug Reference (37th Ed). Great Britain: Pharmaceutical Press. Fruit Interactions with Common Medicines Furanocoumarins can inhibit P-glycoproteins Key messages that are also involved in medicine metabolism z Medicines can interact with whole fruit, (www.medsafe.govt.nz/profs/PUArticles/P- fruit pulp or fruit extracts. glycoproteinSept2011.htm). z Fruit of concern include orange,
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