Rx Shorts provides PCPs with brief, timely updates on a wide variety of matters surrounding prescription drugs. Label changes, supplemental NDAs, FDA advisories, recalls, black box additions, patent expirations, off label uses—the topics are as varied as the pharma news itself. Rx Shorts for August cover:
Reduced opioid manufacturing
Epipen expiration dates extended
Ongoing Shingrix shortage
More insulin/plus combinations
Thyroid meds pulled; is China to blame?
Author Matthew Baker, PharmD, of Lufkin, TX, serves as the Patient Care eyes and ears in the pharmaceutical realm.
The DEA will reduce manufacturing levels of hydrocodone, oxycodone, fentanyl, morphine, oxymorphone, and hydromorphone in 2019. Though circulating levels of these opioids will be lower, the DEA projects that supplies will still be adequate to meet demand while reducing the risk of diversion that comes with excess product. Once manufacturing levels are dictated, the DEA reserves the right to change production quotas for individual manufacturers during the year due to circumstances that might affect supply (eg, recall). Next year will be the third in a row in which the DEA has limited production of these opioids.
GSK is still experiencing difficulties in keeping up with demand for the uber-effective herpes zoster vaccine, Shingrix. Estimates have been given for periodic product releases, but a full recovery is expected in early 2019. Shingrix is a 2-shot vaccine series with the second dose coming 2 to 6 months following initial inoculation. If a patient has received the first dose, but is unable to complete the series in the recommended time due to the shortage, the series need not be restarted. The patient should simply complete the series as soon as possible.
A new product called Xultophy 100/3.6 combines insulin degludec (Tresiba) with liraglutide (Victoza). The once-daily combination injection aims to lower A1c vs insulin or liraglutide alone. Because degludec is combined with liraglutide, an initial starting dose of 16 units should be observed with all patients new to the product (even those starting from higher doses of other basal insulins); 16 units of Xultophy is equivalent to 16 units of degludec and approximately 0.6 mg of liraglutide. Despite a decrease in insulin dose, Novo Nordisk has shown maintenance of fasting blood glucose control when switching to Xultophy from other basal products. A comparable product, Soliqua, is available from Sanofi and combines glargine (Lantus, Basaglar) and lixisenatide (Adlyxin).
Pfizer is working with the FDA in order to extend the expiration dates of specific lots of Epipen 0.3mg in an effort to increase drug availability during the current shortage. The extended expiration dates cover Epipen and its authorized generic (Mylan), but not Epipen Jr. Patients who are unable to locate Epipen 0.3mg at local pharmacies or those whose current prescription is from a lot to which the extended expiration date does not apply should contact Pfizer at 1-800-796-9526 for help finding other pharmacies.
Just weeks after several manufacturers of the hypertension drug valsartan experienced a consumer level recall due to the presence of NMDA, a probable human carcinogen, Westminster Pharmaceuticals is recalling its combination levothyroxine/liothyronine (thyroid tablets) 15mg, 30mg, 60mg, 90mg, and 120 mg due to quality and manufacturing concerns with Chinese supplier Sichuan Friendly Pharmaceutical Co. The FDA had previously issued an import alert in March 2018 that listed concerns with the manufacturing practices of Sichuan Friendly. It is important to note that several manufacturers of levothyroxine and liothyronine are still producing medication so there is no shortage anticipated. Another Chinese company, Zhejiang Huahai Pharmaceuticals, was at the center of the valsartan recall.
Monthly Reminder: Ciprofloxacin, a fluoroquinolone antibiotic, is ubiquitous and diverse in its uses treating everything from uncomplicated cystitis to diverticulitis to inhalational anthrax. Despite its widespread use, important precautions should still be observed when prescribing ciprofloxacin. One such precaution is a drug interaction with the muscle relaxer tizanidine that can often be overlooked. This contraindicated combination may lead to increased plasma concentrations of tizanidine resulting in potential dizziness, bradycardia, and hypotension. If possible, patients should hold tizanidine therapy while taking ciprofloxacin or alternative antibiotic therapy should be considered. Likewise, alternative muscle relaxers like baclofen or cyclobenzaprine can be used in place of tizanidine in those patients for whom ciprofloxacin therapy is necessary. Levofloxacin does not interact with tizanidine and is safe to use in combination with the muscle relaxer.
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