Recalls for arrhythmia drug, infusion pumps, defibrillators
A summary of approvals, recalls, warnings and alerts from the Food and Drug Administration.
Recalls, alerts, reminders
A recall of one lot of cardiac arrhythmia drug propafenone HCl 225 mg (Rythmol) due to oversized tablets that could cause arrhythmias and low blood pressure in sensitive patients. Affected lot 112680A was shipped to customers between Oct. 15, 2008 and Nov. 26, 2008.
A Class I recall of several models of Colleague Single and Triple Channel Volumetric Infusion Pumps, manufactured by Baxter, due to software and battery usage failures which can delay or interrupt infusion and cause serious injury or death. The model numbers are: Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161 and 2M9163.
A Class I recall of 14,054 Welch Allen AED 10 and MRL JumpStart external defibrillators. The products may experience low energy shock, unexpected shutdown and/or susceptibility to electromagnetic noise interference that could lead to death.
An alert that some medicated skin patches contain metal in the backing that can overheat during MRI scans and cause burns. Providers who refer patients to have the scans should check whether they are wearing a patch, advise them how to remove the patch before the scan, then tell them how to replace it after the scan. MRI facilities should follow published safe practice recommendations about patients wearing patches, the FDA said. The affected products include nicotine patches, and may be brand name, generic or over-the-counter.
A reminder not to share insulin pens or cartridges among patients, even if the needles are changed each time, because the practice can transmit blood-borne pathogens. Insulin pens may have been shared among 2,000 patients at a U.S. hospital in 2007-2009, some of whom have subsequently tested positive for hepatitis C.
A recall of Zencore Plus supplements, as they may contain PDE5 inhibitor benzamidenafil. The latter can interact with organic nitrates and pose a sudden, life-threatening drop in blood pressure.
An expanded weight loss product alert to include Herbal Xenicol, Slimbionic and Xsvelten, which may contain the undeclared, active ingredients cetilistat or sibutramine. The alert list now includes 72 products, whose undeclared ingredients like fenproporex, fluoxetine and furosemide may cause high blood pressure, seizures, tachycardia, palpitations, heart attack and stroke.
A Class I recall of 21 lots of the Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube, made by Covidien Inc, due to reports about difficulty inserting the obturator and catheter. The problem may require the tracheostomy tube to be removed and replaced. Affected lot numbers are online.
A voluntary recall of 39 lots of ADHD patch methylphenidate (Daytrana) because patients and caregivers may have trouble removing the liners. Lots affected by the recall are online. The recall isn't due to safety issues.
Approvals
The FC2 Female Condom, a second generation female condom made from a nitrile polymer instead of polyurethane. The new condom will cost about 30% less than the current, first-generation version, which ranges from $1.15 to $2.75 per condom. A randomized, double-blind trial of more than 200 women compared the new and original versions, and found the new version equally safe and effective.
Cervista HPV 16/18, the first DNA test that identifies the two types of human papillomavirus (HPV) that cause the majority of cervical cancers in the U.S. Also approved was the Cervista HPV HR test, which detects high-risk HPV types in cervical cell samples using a method similar to the Cervista HPV 16/18. Taken together with cytology, the tests will help providers determine a patient's risk of cervical disease.
Symbicort (budesonide/formoterol fumarate dihydrate), 160/4.5 mcg twice daily, to treat chronic obstructive pulmonary disease (COPD). The drug, delivered by inhaler, is approved to treat asthma. The most common side effects were common cold, oral candidiasis, bronchitis, sinusitis and viral upper respiratory tract infection.
Antidepressant escitalopram (Lexapro), to treat major depressive disorder in adolescents aged 12 to 17. The drug is already approved for adults.
