Neuropathy Medicine Recall
On November 21, pharmaceutical manufacturer Aurobindo Pharma USA voluntarily recalled one lot of 300-milligram capsules of the antiepileptic medicine gabapentin because some of the capsules have been found to be empty. Gabapentin is used for the treatment of pain caused by diabetic neuropathy (nerve damage), in addition to a variety of other conditions.
The recalled lot is GESB14011-A, which has an expiration date of December 2015 and is packaged in 100-count bottles. The National Drug Code (NDC) is 16714-662-01. The product was distributed under the Northstar label and can be distinguished by the imprint “D” on the yellow cap and “03” on the yellow body with black edible ink.
No adverse events related to the recall have been reported, but four complaints of empty capsules have been received to date.
“Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening,” noted a company press release.
Consumers are advised not to use medicines from the affected lot and to return the product to the place of purchase. They are asked to contact Aurobindo Pharma USA Pharmcovigilance by phone Monday through Friday from 8:30 AM to 5 PM Eastern time at (732) 839-9400 (option 2) or by e-mail at PVG@aurobindousa.com with any questions about the recall.
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Approval of New Pump and CGM Combination System
On November 25, the US Food and Drug Administration (FDA) announced the approval of the Animas Vibe, a combination insulin pump and continuous glucose monitoring (CGM) system that is the first to include Dexcom G4 Platinum CGM technology.
The system provides users with their glucose readings (taken automatically every five minutes) and directly on the high-contrast, color pump screen, meaning that no separate CGM receiver is needed. The CGM sensor is approved for up to seven days of continuous wear. Other key features of the system include a nonadjustable hypoglycemia (low blood glucose) alert set at 55 mg/dl, personalized audio alerts, a basal rate increment of .025 units/hour, a bolus rate increment of 0.05 units, and waterproof capabilities at up to 12 feet for up to 24 hours.
The Animas Vibe is approved for people with diabetes ages 18 and up who require insulin to manage their condition. The manufacturer is now taking orders, with the system scheduled to become available in January 2015. The retail price (prior to factoring in insurance) is $7,150 for the vibe, $799 for the CGM transmitter, and $499 for each four-pack of sensors. The system will be covered by insurance like other pumps, and according to website diaTribe, Animas can inform prospective users what they will pay based on the insurance plan they have.
Current Animas OneTouch Ping users with a pump that is still in warranty and that was purchased prior to December 1, 2014, can upgrade to the Animas Vibe for $99 via the “ezAccess Upgrade Program.”