Drug Updates: Lorcaserin, Acetaminophen, and More

The combination of phentermine and topiramate has been FDA approved for overweight or obese patients who have at least one weight-related condition, including hypertension, diabetes, or dyslipidemia.⁸ This combination product, known as Qysmia, is approved with a REMS. It is the second weight-loss product to be approved in more than ten years.

Lorcaserin was FDA approved in late June as an adjunct to a reduced-calorie diet and exercise for chronic weight management in obese (body mass index [BMI]>30) or overweight (BMI>27) adults with at least one of the weight-related conditions noted above.⁹ Lorcaserin activates the serotonin 2C receptor in the brain, which may help patients eat less and feel sated after eating smaller food amounts. Lorcaserin can cause serotonin syndrome if used with other medications that increase serotonin levels or activate serotonin receptors. These agents include migraine therapies and antidepressants. Lorcaserin can also cause memory and attention disturbances. Both Lorcaserin and Qysmia can cause headaches, nausea, dizziness, and fatigue, and the FDA is requiring that the manufacturers of both agents conduct longer-term studies to evaluate stroke and heart risks.¹⁰

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. U.S. Food and Drug Administration. Organ-specific warnings: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use—Labeling for products that contain acetaminophen. Published July 2012. Available at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM310477.pdf. Accessed August 7, 2012.
2. Meier RPH, Perneger TV, Stern R, Rizzoli R, Pete RE. Increasing occurrence of atypical femoral fractures associated with bisphosphonate use. Arch Intern Med. 2012;172:930-936.
3. Zhang J, Xie F, Delzell E, et al. Association between vaccination for herpes zoster and risk of herpes zoster infection among older patients with selected immune-mediated diseases. JAMA. 2012;308:43-49.
4. Liscinsky M. FDA introduces new safety measures for extended-release and long-acting opioid medications. Published July 9, 2012. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310870.htm. Accessed July 19, 2012.
5. Lowes R. FDA puts 16 drugs on watch list. Published April 17, 2012. Available at www.medscape.com/viewarticle/762205. Accessed July 17, 2012.
6. FDA Drug Safety Communication. Prescription acetaminophen products to be limited to 325 mg per dosage unit; boxed warning will highlight potential for severe liver failure. Published January 13, 2011. Available at www.fda.gov/Drugs/DrugSafety/ucm239821.htm. Accessed August 7, 2012.
7. Abbott Pharmaceuticals. Vicodin: Health professionals FAQs. Published May 2012. Available at www.vicodin.com/hcp/faq.cfm. Accessed August 7, 2012.
8. Dane L. FDA approves Vivus’ weight loss drug Qsymia. Published July 12, 2012. Available at www.firstwordpharma.com/node/1002971. Accessed July 19, 2012.
9. U.S. Food and Drug Administration. FDA approves Belviq to treat some overweight or obese adults. Published June 27, 2012. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309993.htm. Accessed August 7, 2012.
10. Kotz D. Should you take one of the new weight loss drugs? Published July 19, 2012. Available at www.boston.com/dailydose/2012/07/19/should-you-take-one-the-new-weight-loss-drugs/BwVXJevZ7FutoFttOQiKlM/story.html. Accessed July 20, 2012.