Patients with insulin-dependent diabetes; pharmacists
WalMart "ReliOn" insulin syringe recall due to potential for serious overdose
Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile,
single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles.
The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times
the intended dose, with serious health consequences, low blood sugar, and even death.
These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name.
The recall applies only to lot number 813900. The product was distributed from
Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes.
FDA urges patients and health care professionals to check syringe packaging carefully for
products with this lot number, not to use the product, and return the product to the pharmacy
for replacement. The lot number can be found on the back panel of the 100 count syringe
carton, or on the white paper backing of each individual syringe “peel-pack”.


Products Recalled Due To The Potential For Oversized Tablets
Audience: Pharmacists, other healthcare professionals, patients
Propafenone HCl, Isosorbide Mononitrate Extended Release,
Morphine Sulfate Immediate and Extended Release, Dextroamphetamine Sulfate-
Propafenone HCl Tablets 150 mg, 225 mg, and 300 mg
Isosorbide Mononitrate Extended Release Tablets 30 mg and 60 mg
Morphine Sulfate Extended Release Tablets 15 mg
Morphine Sulfate Immediate Release Tablets 15 mg and 30 mg
Dextroamphetamine Sulfate Tablets 10 mg
 
Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products
(Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended
Release Tablets, Morphine Sulfate Immediate Release Tablets, and Dextroamphetamine Sulfate Tablets).
The products were recalled because they may contain oversized tablets. Oversized tablets may
contain more than the intended levels of the active drug ingredient that could result in patients
receiving as much as twice the expected dosage of these drugs, which could cause serious
or life-threatening consequences.
Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low
blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with
Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate.
Patients who experience any adverse reactions to these drugs should contact their healthcare
professional immediately. See the manufacturer's recall notice for specific lot numbers of the
products affected by this recall.


Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)-
Product Recalled Due To Possible Metal Fragments In The Bottle
Audience: Consumers, pediatricians, other healthcare professionals
Johnson & Johnson- Merck Consumer Pharmaceuticals Company and FDA notified consumers
and healthcare professionals of a voluntary recall of Infants' Mylicon Gas Relief Dye Free Drops
( Lot No. SMF007 and SMF008) sold in 1 oz plastic bottles that were distributed after October 5, 2008,
nationwide. The product was recalled because some bottles could include metal fragments
that were generated during the manufacturing process. Parents who have given the product
to their infant and are concerned should contact their healthcare professional.


Bisphosphonates-Update To The Early Communication Issued Regarding
Atrial Fibrillation With Bisphosphonates
Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D)
Etidronate (Didronel)
Ibandronate (Boniva)
Pamidronate (Aredia)
Risedronate (Actonel, Actonel W/Calcium)
Tiludronate (Skelid)
Zoledronic acid (Reclast, Zometa)
Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals
FDA issued an update about the Agency's review of safety data regarding the potential increased
 risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates
are a class of drugs used primarily to increase bone mass and reduce the risk for fracture
in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone,
and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer.
FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated
patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was
rare within each study, with most studies containing 2 or fewer events. Across all studies,
no clear association between overall bisphosphonate exposure and the rate of serious or
non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of
 bisphosphonate therapy was not associated with an increase rate of atrial fibrillation.
Healthcare professionals should not alter their prescribing patterns for bisphosphonates
and patients should not stop taking their bisphosphonate medication.