FDA Review: phosphate binders, drug-eluting stents
By Jessica Berthold
An FDA advisory committee will meet October 16 on extending the use of phosphate binders from the dialysis to the pre-dialysis population. A separate panel will meet in October to review the drug-eluting stent Endeavor; no meeting date had been set as of press time.
Alerts, warnings, label changes
Doctors should discuss the signs of morphine overdose in infants when prescribing codeine-containing drugs to nursing women. Mothers with a rare metabolic genotype who take codeine may convert the drug to morphine faster than most people, which can lead to high breast milk morphine levels and overdose in infants. Doctors should prescribe the lowest effective dose for the shortest period of time to nursing mothers, and advise them to watch their infants for signs of unusual sleepiness, difficulty breast-feeding or breathing, or limpness.
New prescribing information for warfarin says that doctors may want to consider adjusting initial doses for patients with variants of the genes CYP2C9 and VKORC1. These gene variants can indicate how a patient will respond to the drug. Medicare covers the costs of the $300-$500 genetic test, but some large insurers may not.
Due to a case report, hepatitis B drug Entecavir (Baraclude) will carry a black box warning for its potential to cause HIV resistance in patients with both HIV and hepatitis B unless those patients are also taking active anti-retroviral therapy.
The thiazolidinedione class of diabetes drugs will carry black-box warnings about heart failure risk. The warning will apply to rosiglitazone (Avandia), pioglitazone (Actos), as well as combination drugs Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin) and Duetact (pioglitazone and glimepiride). The warning advises health care professionals to observe patients for signs of heart failure, such as shortness of breath, edema and rapid weight gain, after starting the drugs. People with serious or severe heart failure also shouldn’t use the drug.
A new smallpox vaccine, ACAM2000, meant to inoculate those at high risk of exposure. Derived from the nation’s old smallpox vaccine, Dryvax, the new vaccine can be made quickly to protect people during a bioterrorist attack. In studies, about 1 in 175 healthy adults who received ACAM2000 for the first time developed myocarditis and/or pericarditis.
An intravenous injection of zoledronic acid (Reclast), the first once-a-year treatment for women with postmenopausal osteoporosis. The drug, already used to treat Paget disease, will be given as a 15-minute infusion. In a three-year trial, zoledronic acid reduced the risk of spine fractures by 70% and hip fractures by 41%, and increased bone mineral density. Serious atrial fibrillation was more common in women on the drug vs. placebo.
The Senographe Essential mobile mammogram, which has the largest digital detector in the mammography market, to bring screening to remote areas with limited medical technology.
A generic version of famciclovir (Famvir), a genital herpes drug, to be sold in 125 mg, 250 mg and 500 mg doses. Also, a generic version of the hypertension drug quinapril (Accupril) to be sold in 5 mg, 10 mg, 20 mg and 40 mg doses.
Human thrombin (Evithrom), a blood-clotting protein that helps control bleeding from capillaries and small veins during surgery. A clinical trial found Evithrom comparable to cattle-derived thrombin in safety and effectiveness.
The cobas TaqScreen test to screen for West Nile virus in donated blood and organs. The automated test detects the genetic material of the virus early in the infection, before the donor's body has started producing antibodies against the virus.
Lanreotide acetate injection (Somatuline Depot) to treat acromegaly, a rare and possibly life-threatening disease caused by abnormal secretion of growth hormone, in patients for whom other therapies are inadequate.
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