Warnings, recalls, label changes
A recall of fentanyl pain-relief patches sold by Actavis South Atlantic LLC and manufactured by Corium International Inc., due to a packaging defect that may bring patients or caregivers in direct contact with the potent opioid gel. The patches are double-branded with the name Actavis on the box and Abrika Pharmaceuticals, the company's former name, on the pouches. The recall includes 25-microgram-per-hour, 50-microgram-per-hour, 75-microgram-per-hour and 100-microgram-per-hour fentanyl patches with expiration dates between May and August 2009. Duragesic-brand fentanyl patches, sold by PriCara, are also recalled for a similar defect; the recall affects 25-microgram-per-hour patches that expire on or before December 2009.
Natalizumab (Tysabri) should be discontinued in patients with jaundice or other evidence of significant liver injury as it may cause elevated serum hepatic enzymes and elevated total bilirubin as early as six days after the first dose. These elevations could lead to severe liver injury that may cause death or the need for a liver transplant.
Botulinum toxin Type A (Botox and Botox Cosmetic) and botulinum toxin Type B (Myobloc) may cause adverse reactions, including respiratory failure and death, possibly due to overdosing. The most severe effects reported were in children with cerebral palsy who were treated for spasticity in their limbs—an unapproved use. The FDA is reviewing the matter and doesn't advise discontinuing prescriptions of these products.
A recall of several models of the Medtronic SynchroMed EL Implantable Infusion Pump. The recalled models are: 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. They were recalled because some pump motors may stall, stopping drug delivery suddenly and possibly leading to withdrawal, which can be fatal.
A recall of NuCel Labs eye drops and eye/ear wash products after tests showed the presence of bacteria and particulate matter that pose a risk of eye infections.
Bevacizumab (Avastin) to treat metastatic breast cancer. The drug, already approved to treat colon and lung cancer, was approved based on findings that it slowed tumor growth, though it didn't extend patients' lives.
The Endeavor zotarolimus-eluting coronary stent, the first drug-eluting stent approved since the FDA discussed evidence of blood clots in patients who receive these stents in 2006. Several studies showed Endeavor significantly reduced the number of major coronary events compared to a bare-metal stent and cut the restenosis rate by about half, though the restenosis rate was higher than with other approved drug-eluting stents. To reduce clotting risk, Endeavor patients will need to take blood-thinning medication for at least six months after implantation.
The first generic versions of alendronate sodium tablets (Fosamax) for treating osteoporosis. The tablets will be available in 5-mg, 10-mg, and 40-mg doses to be taken once daily, and 35-mg and 70-mg doses to be taken once weekly.
Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, a treatment for hemophilia A. Side effects may include headache or fever.
Patients taking rosiglitazone (Avandia) will receive a new medication guide that says the drug can cause or worsen heart failure, and increase the risk of myocardial infarction and angina.
The FDA has selected the following viral strains for the 2008-09 flu season vaccine: A-Brisbane/59, A-Brisbane/10 and B-Florida. It's the first time in 20 years that federal officials called for a total reformulation of the vaccine.