News Brief for August 2016

Black-Box Warnings for Abuse, Addiction to Be Added to Opioid Painkillers
The Food and Drug Administration (FDA) in March announced it will require stronger warnings on immediate-release opioid medications.[1] These powerful painkillers — examples include hydrocodone (ANEXSIA, NORCO, REPREXAIN) and oxycodone (OXAYDO, PERCOCET, ROXICODONE) — will be given a black-box warning about the risks of abuse, addiction, overdose and death. The FDA has issued the warnings in response to what Commissioner Robert Califf calls "epidemic levels" of pain drug addiction and overdose. Worst Pills, Best Pills News has written extensively on the dangers of these medications[2] and reported in March[3] that the epidemic of opioid abuse had led the Centers for Disease Control and Prevention to issue guidelines for prescribing these drugs.

FDA: Consumers Should Avoid Over-the-Counter Chelation Products
The Food and Drug Administration (FDA) on Feb. 1 issued a drug safety alert reminding consumers not to purchase over-the-counter (OTC) products marketed for chelation.[4] Chelation is a process of removing toxic metals from the body using chemicals for treatment of metal poisoning and other conditions. The FDA has never approved any OTC chelation products, but OTC products are often illegally marketed to give the impression that they are FDA-approved. Some are sold as dietary supplements. Companies claim these products can prevent or treat a wide range of conditions, including autism, heart disease and Alzheimer’s disease. All FDA-approved chelation products require a prescription because they have dangerous side effects and are safe only when used under the supervision of a health care provider, the FDA warned.

One Major Drugmaker Abandons Inhaled Insulin Product AFREZZA
Citing poor sales, drug marketer Sanofi has terminated its involvement in the marketing of the inhaled insulin product AFREZZA.[5] The drug had not met sales expectations since being introduced in the U.S. in February 2015. Worst Pills, Best Pills News published an article in December 2015 warning against use of AFREZZA, stating that it was ineffective and caused unique side effects including coughing, shortness of breath and possibly lung cancer.[6] AFREZZA is not the first inhaled insulin to have disappointing results on the market; Pfizer’s drug EXUBERA was withdrawn a year after its 2006 launch.[7] MannKind, AFREZZA’s owner, plans to reintroduce the drug at a lower price.

References

[1] Food and Drug Administration. FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death. March 22, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491739.htm. Accessed April 12, 2016.

[2] See, for example, Long-acting opioids: Extra caution needed. Worst Pills, Best Pills News. December 2015. /newsletters/view/1003. Accessed April 12, 2016; and The FDA must restrict the use of prescription narcotic hydrocodone. Worst Pills, Best Pills News. March 2013. /newsletters/view/838. Accessed April 12, 2016.

[3] CDC seeks to rein in overprescribing of opioids for chronic pain. Worst Pills, Best Pills News. March 2016. /newsletters/view/1020. Accessed April 12, 2016.

[4] Food and Drug Administration. Medication health Fraud: Questions and answers on unapproved chelation products. Last updated February 2, 2016. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm229313.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed May 2, 2016.

[5] Hirschler B. Poor sales prompt Sanofi to pull plug on Mannkind inhaled insulin. Medscape (Reuters). January 6, 2016. http://www.medscape.com/viewarticle/856761. Accessed May 17, 2016.

[6] Inhaled insulin AFREZZA ineffective, can damage lungs. Worst Pills, Best Pills News. December 2014. /newsletters/view/1000. Accessed May 17, 2016.

[7] Mack GS. Pfizer dumps Exubera. Nat Biotechnol. 2007;25(12):1331-2. http://www.nature.com/nbt/journal/v25/n12/full/nbt1207-1331.html. Accessed June 6, 2016.