Drug Safety Communications (Q2 & Q3 2017)

1. EpiPen and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device

Released 3/31/2017

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.

While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Stericycle at 877-650-3494.

Both reports are related to the single lot that was previously recalled. The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty between December 2015 and July 2016. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.

2. Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women

Released 4/20/2017

FDA is restricting the use of codeine and tramadol medicines in children. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.

As a result, FDA is requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond the 2013 FDA restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.

3. Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength

Released: 5/8/2017

C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30 mg tablets.

This mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma or death.

4. Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations

Released: 5/16/2017

Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.

5. Urgent Medical Device Recall-Becton Dickinson

Released: 5/25/2017

BD is conducting a product removal recall of lot 6291768 of the BD Insulin Syringes with the BD Ultra-FineTM needle ½mL 12.7mm 30G, Catalog # 328466, because some polybags in the lot are incorrectly labeled as BD Ultra-FineTM needle ½mL 8mm 31G, Catalog # 328468. The shelf carton is correctly labeled as BD Insulin Syringes with the BD Ultra-FineTM needle ½mL 12.7mm 30G. The affected recalled lot was distributed from March 3rd to May 31st, 2017.

BD Insulin Syringes with the BD
Ultra-FineTM needle ½ mL 12.7mm
30G

6. Eliquis (apixaban) 5 mg tablets: Recall One Lot- Bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets

Released: 6/13/2017

Bristol-Myers Squibb Company is voluntarily recalling one lot (#HN0063) of Eliquis 5 mg tablets to the consumer level. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets.

7. Mibela 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.: Recall - Out of Sequence Tablets and Missing Expiry/Lot Information

Released: 5/29/2017

Lupin Pharmaceuticals Inc. announced a recall of lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets at the consumer level. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets.

As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy. The reversing the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the tablets out of order. For patients in whom a pregnancy is contraindicated or in whom concomitant medication(s) may have teratogenic effects, an unintended pregnancy may cause significant adverse maternal or fetal health consequences, including death.To date there have been no reports of such adverse events.

8. Paliperidone Extended-Release (INVEGA) Tablets 3mg by Teva Pharmaceuticals: Recall - Dissolution Test Failure

Released: 6/15/2017

Teva Pharmaceuticals USA, Inc. initiated a voluntary recall to retail-level on 05/31/2017 for one lot of Paliperidone Extended-Release Tablets, 3mg, 90 count bottles, lot 1160682A, expiration 6/2018, NDC 0591-3693-19, that was distributed under the Actavis Pharma Inc. label. In coordination with FDA, Teva is extending this recall to the consumer/user level.

This recall is being carried out due to failing test results for dissolution. Teva cannot at this time exclude the potential for additional tablets to be below specification.

Taking a product for the treatment of schizophrenia and schizoaffective disorders that has failed dissolution could result in less drug being absorbed. If two or more consecutive dosing regimens are with affected product, a failure to maintain therapeutic levels could occur, which could reduce effectiveness in treating a patient’s mental and/or mood symptoms, including suicidal thoughts and behavior, self-injurious behavior, mental hospitalizations, assaults, aggressive behavior, as well as vocal and motor tics.

Based on Teva’s investigation, the likelihood of consuming two or more consecutive doses with affected product is low. In addition, no post marketing adverse events have been received to date for lack of effectiveness for this recalled lot.