Drug Updates

Quinine sulfate (Qualaquin) continues to be used off label to manage night-time leg cramps and restless leg syndrome, yet quinine is only approved by the FDA to treat uncomplicated malaria.¹⁸ Use of quinine sulfate can cause serious and life-threatening hematologic reactions including thrombocytopenia and hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura (TTP), which can result in permanent kidney damage. There have been at least 38 cases of serious adverse events, most requiring hospitalization. The median time to onset of hematologic adverse reactions was 13.5 days after starting quinine sulfate. Two deaths were reported, one due to TTP and one due to hemolysis. The risk management plan for quinine sulfate required that a patient receive a medication guide as part of the FDA’s Risk Evaluation and Mitigation Strategy (REMS). A Dear Healthcare Professional letter was also issued for this product.

Michele Kaufman is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Gever J. EULAR: Anakinra may stop early JIA in its tracks. www.medpagetoday.com/tbprint.cfm?tbid=20818. Published June 22, 2010. Accessed October 13, 2010.
2. De Jager W, Vastert SJ, Holzinger D, et al. Anakinra treatment prior to steroids in newly diagnosed systemic onset JIA; changing the biology? Ann Rheum Dis. 2010; 69 (Suppl. 3): 624.
3. GlaxoSmithKline, Human Genome Sciences’ lupus drug Benlysta granted FDA priority. Published August 19, 2010. www.firstwordplus.com/Fws.do?articleid=6BEDBD6542D945A5BD3F67E123196775#. Accessed October 13, 2010.
4. GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus. www.gsk.com/media/pressreleases/2010/2010_pressrelease_10083.htm. Published August 19, 2010. Accessed October 13, 2010.
5. Phase 3 study of oral calcitonin for the treatment of postmenopausal osteoporosis. www.empr.com/phase-3-study-of-oral-calcitonin-for-the-treatment-of-postmenopausal-osteoporosis/article/175232/. Published July 23, 2010. Accessed October 13, 2010.
6. Susman E. EULAR: Canakinumab prevents flares in gout patients. www.medpagetoday.com/MeetingCoverage/EULAR/20776. Published June 20, 2010. Accessed August 24, 2010.
7. US Food and Drug Administration. Ilaris: Highlights of prescribing information. www.accessdata.fda.gov/drugsatfda_docs/label/2009/125319s000lbl.pdf. Published June 17, 2009. Accessed October 13, 2010.
8. Chelsea Therapeutics announces FDA approval of CH-4501 Phase II protocol. www.irconnect.com/chtp/pages/news_printer.html?d=200159&print=1. Published August 26, 2010. Accessed October 13, 2010.
9. Walker E. Equivocal message on duloxetine for pain from panel. www.medpagetoday.com/ProductAlert/Prescriptions/21784. Published August 19, 2010. Accessed September 7, 2010.
10. Phase 3 study of Ketotransdel for pain. www.empr.com/phase-3-study-of-ketotransdel-for-pain/article/178206/. Published September 3, 2010. Accessed September 7, 2010.
11. Progenics Pharmaceuticals initiates oral methylnaltrexone Phase 3 trial in patients with chronic non-cancer pain. www.progenics.com/releasedetail.cfm?ReleaseID=505503. Published September 8, 2010. Accessed October 13, 2010.
12. Susman E. EULAR: Experimental compound helps gout patients, lowers uric acid. www.medpagetoday.com/tbprint.cfm?tbid=20775. Published June 20, 2010. Accessed October 13, 2010.
13. Susman E. EULAR: Novel hyperuricemia drug promising. www.medpagetoday.com/tbprint.cfm?tbid=20843. Published June 23, 2010. Accessed August 24, 2010.
14. New patient safety alliance launches tools to fight pain medication misuse and abuse. www.caresalliance.com/Resources/CARES%20Alliance%20launch%20release_FINAL.pdf. Published September 8, 2010. Accessed September 8, 2010.
15. Cares Alliance website. www.caresalliance.com/. Accessed September 8, 2010.
16. Cares Alliance Professional website www.caresalliance.org/. Accessed September 8, 2010.
17. Gever J. FDA warns of meningitis linked to lamotrigine. www.medpagetoday.com/tbprint.cfm?tbid=21647. Published August 12, 2010. Accessed October 13, 2010.
18. FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate). www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm218202.htm?sms_ss=email. Published July 8, 2010. Accessed October 13, 2010.
19. Dane L. FDA panel votes that benefits of Jazz’s fibromyalgia drug don’t outweigh risks. www.firstwordplus.com/Fws.do?articleid=14A27AE78A45416FB350D07DA9437484. Published August 20, 2010. Accessed September 7, 2010.
20. Jazz Pharmaceuticals provides update on FDA Advisory Committee Meeting for JZP-6 (sodium oxybate) in fibromyalgia. http://investor.jazzpharma.com/phoenix.zhtml?c=210227&p=irol-newsArticle&ID=1462055&highlight= Published August 20, 2010. Accessed September 8, 2010.
21. Antipolis S. FDA provides Complete Response Letter to NicOx’s New Drug Application for naproxcinod. www.nicox.com/upload/PR_CRL_22072010_EN.pdf. Published July 22, 2010. Accessed October 13, 2010.
22. Antipolis S. NicOx to close US headquarters. www.nicox.com/upload/PR_Warren_030810_EN.pdf. Published August 4, 2010. Accessed September 8, 2010.
23. MonoSol Rx Announces Reckitt Benckiser FDA Approval of Suboxone Sublingual Film for Treatment of Opioid Dependence. www.prnewswire.com/news-releases/monosol-rx-announces-reckitt-benckiser-fda-approval-of-suboxone-sublingual-film-for-treatment-of-opioid-dependence-101874388.html. Published August 31, 2010 Accessed August 31, 2010.
24. First-time generic approvals August 2010. http://formularyjournal.modernmedicine.com/formulary/Modern+Medicine+Now/First-time-generic-approvals-August-2010/ArticleStandard/Article/detail/683182?contextCategoryId=44276. Published August 1, 2010. Accessed October 13, 2010.