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Drug Information Bulletin (Electronic)

Volume: 4

Drug Information Centre (DIC) Indian Pharmaceutical Association, Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

1st December 2010 World AIDS Day

Number: 33

27th November 2010

Content Propoxyphene: Withdrawal from US market due to Risk of Cardiac Toxicity Dextropropoxyphene: withdrawal Sodium valproate and carbapenems: interaction Pregabalin: suicidal ideation World AIDS Day GSK Transfers Ownership of U.S. Penicillin Facility and Products to Dr. Reddy's Suspension of import/manufacture of sibutramine & R-sibutramine and their formulations in India

Propoxyphene: Withdrawal from US market due to Risk of Cardiac Toxicity ISSUE: FDA notified healthcare professionals that Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene, an opioid pain reliever used to treat mild to moderate pain, from the U.S. market at the request of the FDA, due to new data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses. FDA requested that the generic manufacturers of propoxyphene-containing products remove their products as well. BACKGROUND: FDA's recommendation is based on all available data including data from a new study that evaluated the effects that increasing doses of propoxyphene have on the heart (see Data Summary in Drug Safety Communication). The results of the new study showed that when propoxyphene was taken at therapeutic doses, there were

significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes can increase the risk for serious abnormal heart rhythms. RECOMMENDATION: FDA recommends that healthcare professionals stop prescribing and dispensing propoxyphene-containing products to patients, contact patients currently taking propoxyphene-containing products and ask them to discontinue the drug, inform patients of the risks associated with propoxyphene, and discuss alternative pain management strategies. Patients were advised to dispose of unused propoxyphene in household trash by following the recommendations outlined in the Federal Drug Disposal Guidelines.
Source: e-drug

Dextropropoxyphene: withdrawal New Zealand Healthcare professionals are reminded that the consent to distribute dextropropoxyphene containing medicines

2 (Capadex, Paradex) was revoked on 1 August 2010. From this date it is no longer legal to sell, distribute or advertise these medicines unless exempted under the Medicines Act 1981 (1). This decision follows a review by the Medicines Adverse Reactions Committee (MARC), which concluded that the risks of these medicines outweigh benefit (2). The Best Practice Advocacy Centre (bpacNZ) has issued advice for transferring patients from dextropropoxyphene (3). Oxycodone should not be prescribed in place of dextropropoxyphene unless there has been an inadequate response to a weak opioid. Oxycodone is a strong opioid and is only indicated as an alternative to morphine on step three of the WHO analgesic ladder. References 1. Medsafe. DHCPL dated 26 March 2010. Available at:http://www.medsafe.govt.nz/ LtrtoHPCapadexandParadex.pdf 2. MARC minute item for dextropropoxyphene, December 2009. Available at: www.medsafe. govt.nz/profs/adverse/Minutes140.htm#3.1 bpacNZ. 2010. 3. Dextropropoxyphene containing medicines to be withdrawn. Best Practice Journal. 26: 44. http://www.medsafe.govt.nz/profs/PUArticles / DextropropoxypheneWithdrawalReminder.ht m 4. Dextropropoxyphene withdrawal a reminder. Prescriber Update. 2010; 31(2):11 at http://www.medsafe.govt.nz Sodium valproate and carbapenems: interaction New Zealand Prescribers are reminded of the clinically significant interaction between carbapenem antibiotics (such as imipenem, meropenem and ertapenem) and sodium valproate. international reports suggest it is more severe than initially thought. The interaction has been reported to result in a 60100% decrease in valproate plasma concentration within two days and reduced therapeutic effect. The underlying mechanism of action is yet to be explained (1). Monitoring valproate plasma levels or adjusting the dose is unlikely to manage this interaction given its extent and rapid onset. Prescribers are therefore advised to avoid the use of carbapenem antibiotics in patients taking sodium valproate. References 1. European Medicines Agency. 28 January 2010. Monthly Report Pharmacovigilance Working Party, January 2010 Plenary Meeting. http://www.ema.europa.eu/pdfs/human/phv wp/3313810en.pdf 2. Sodium valproate and carbapenems Interaction. Prescriber Update, 2010; 31(2):14 Pregabalin: suicidal ideation Canada Health Canada has received 16 reports of suicidal ideation and one report of suicide attempt suspected of being associated with the use of pregabalin (Lyrica). The Canadian product monograph for Lyrica lists suicide attempt under less common clinical trial adverse drug reactions and describes it as being infrequent. Seven of the 16 cases included a positive dechallenge, and one case included a positive rechallenge. Pregabalin has analgesic, antiepileptic and anxiolytic activity (1). Marketed in Canada since July 2005, pregabalin is indicated for the management of neuropathic pain associated with diabetic neuropathy, postherpetic neuralgia and pain associated with fibromyalgia in adults, and it may be useful in the management of central neuropathic pain. The Canadian product monograph for Lyrica lists suicide attempt under less common clinical trial adverse drug reactions and describes it as being infrequent (1). Patients with chronic pain are

3 at increased risk of depression, which may lead to suicidal ideation and attempt, so the indication for taking pregabalin in these patients may also be a confounding factor (2). In the United States, pregabalin is also indicated as adjunctive therapy in adults with partial onset seizures (3). It is not approved for this indication in Canada. In December 2008 and April 2009, the US Food and Drug Administration communicated safety notices concerning the increased risk of suicidal behaviour and ideation in patients taking antiepileptic drugs, including pregabalin, for any indication (4, 5). Extracted from Canadian Adverse Reaction Newsletter, Volume 20(3), July 2010 References 1. Lyrica (pregabalin) [product monograph]. Kirkland (QC): Pfizer Canada Inc; 2009. 2. Gilbert JW, Wheeler GR, Storey BB, et al. Suicidality in chronic noncancer pain patients. Int J Neurosci 2009; 119(10):1968-79. 3. Lyrica (pregabalin) capsules [prescribing information]. New York (NY): Pfizer Inc.; 2009. 4. Suicidal behaviour and ideation and antiepileptic drugs. Rockville (MD): US Food and Drug Administration; December 2008. http://www.fda.gov 5. Lyrica (pregabalin) capsules detailed view: safety labelling changes approved by FDA Center for Drug Evaluation and Research (CDER). Rockville (MD): US Food and Drug Administration; April 2009. http://www.fda.gov World AIDS Day (1 December 2010) World AIDS Day on 1 December draws together people from around the world to raise awareness about HIV/AIDS and demonstrate international solidarity in the face of the pandemic. The Day is one of the most visible opportunities for public and private partners to spread awareness about the status of the pandemic and encourage progress in HIV/AIDS prevention, treatment and care in high prevalence countries and around the world. There are now 33.4 million people living with HIV, according to 2008 figures released by WHO. An estimated 2.7 million were newly infected with the virus and 2 million died of AIDS the same year. Sub-Saharan Africa remains the region most heavily affected by HIV. In 2008, sub-Saharan Africa accounted for 67% of HIV infections worldwide, 68% of new HIV infections among adults and 91% of new HIV infections among children. The region also accounted for 72% of the worlds AIDS-related deaths in 2008. GSK Transfers Ownership of U.S. Penicillin Facility and Products to Dr. Reddy's Britain's GlaxoSmithKline (GSK) and India's Dr. Reddy's Laboratories said yesterday that they signed an agreement in which GSK will transfer ownership of its U.S. penicillin manufacturing site and rights for Augmentin and Amoxil brands in the United States to Dr. Reddy's. The transaction is expected to close during the first half of 2011. Additional details were not disclosed.

4 Suspension of import/manufacture of sibutramine & R-sibutramine and their formulations in India