Peggy Peck

ROCKVILLE, Md -- The FDA has taken steps to ensure that clinicians and patients are aware of rare bizarre effects associated with sedative hypnotics, including driving or eating while sleeping.

ROCKVILLE, Md. -- The FDA today approved lapatinib (Tykerb), an oral kinase inhibitor that targets HER2-positive tumors, for treatment-refractory metastatic breast cancer, to be used in combination with capectabine (Xeloda).

ROCKVILLE, Md. -- For the second time in two weeks, the FDA has informed physicians of an excess fracture risk in women taking an oral diabetes drug in the thiazolidinedione class. This time the drug is pioglitazone (Actos).

ROCKVILLE, Md. -- More than 40,000 automatic external defibrillators in schools, health clubs, and other public sites have been recalled because of a potentially faulty low-battery signal, the FDA reported.

ROCKVILLE, Md. -- The FDA said today it has approved aliskiren (Tektuma), the first oral direct renin inhibitor for treatment of hypertension.

ROCKVILLE, Md. -- The FDA has licensed an automated nucleic acid test to screen donor blood for West Nile virus.

ROCKVILLE, Md. -- The FDA has warned about a norovirus outbreak linked to raw oysters harvested in San Antonio Bay, on the Texas Gulf coast north of Corpus Christi.

ROCKVILLE, Md. -- The FDA has approved lisdexamfetamine dimesylate (Vyvanse), formerly known as NRP104, for attention deficit hyperactivity disorder.

KISSISSIMEE, FLA. -- Escalated-dose conformal radiotherapy for localized prostate cancer was associated with a 34% reduction in the relative risk of biochemical failure in a randomized trial of 843 men also with treated with androgen deprivation therapy.

ROCKVILLE, Md. -- Anaphylaxis reports associated with the asthma drug omalizumab (Xolair) led the FDA today to order Genentech to add a black box warning to the agent's label.

ROCKVILLE, Md. -- The FDA informed physicians today of a report by GlaxoSmithKline of an increased number of arm, hand, and foot fractures among women taking rosiglitazone (Avandia) for newly diagnosed type 2 diabetes.

ATLANTA -- In West Virginia, every 10th adult has had a heart attack or suffers from coronary artery disease, with or without symptoms of angina, according to a CDC survey. No state has a worse record.

ROCKVILLE, Md. -- The FDA said today it has had reports of Americans needing emergency medical treatment after taking what's been identified as the antipsychotic drug haloperidol sent by shady Internet sites instead of the drugs that were ordered.

ROCKVILLE, Md. -- Two brands of peanut butter manufactured in a single Georgia facility may be contaminated with Salmonella serotype Tennessee, according to the FDA.

ROCKVILLE, Md. -- The FDA has notified physicians that the year since RotaTeq, an oral rotavirus vaccine, was approved, there have been 28 reported post-marketing cases of intussusception. It is not known whether the cases were causal or coincidental, the agency said.

ROCKVILLE, Md. -- The FDA today approved over-the-counter sale of a low-dose version of Xenical (orlistat), a prescription diet drug that works by blocking the absorption of fat in the intestine. The OTC version will be called Alli.

ROCKVILLE, Md. -- The FDA said today it has approved the first microarray genetic analysis designed to aid in predicting the risk of stage I or II breast cancer recurrence or metastasis.

ROCKVILLE, Md. -- The FDA has approved Alphanate (antihemophilic factor/von Willebrand factor complex) for von Willebrand's disease in surgery.

ROCKVILLE, Md. -- Four months after the Institute of Medicine scolded the FDA for its regulation of drug safety, the FDA countered with a response that sidestepped some of the key recommendations for reform.

ROCKVILLE, Md. -- For cancer patients with anemia not caused by chemotherapy, the off-label use of Aranesp (darbepoetin alfa) is ineffective and also boosts mortality, the FDA reported.

ORLANDO -- For predicting survival after pancreatic cancer surgery, the ratio of metastatic to examined nodes might be more accurate than the absolute number metastatic nodes sampled, researchers reported here.

SPRINGFIELD, Mass. -- Offering hospitals a relatively small financial incentive improved their quality of care for acute myocardial infarction, heart failure, and pneumonia, researchers here reported.

ROCKVILLE, Md. -- An FDA advisory panel has recommended that the agency expand post-marketing surveillance of oral contraceptives and require that their manufacturers study safety and efficacy in wide-ranging populations.

ORLANDO -- A genetic signature related to telomerase has been strongly associated with an increased risk of death in patients with gastrointestinal stromal tumors (GIST), researchers reported here.

PHILADELPHIA -- The FDA has approved a once-daily formulation of Lialda (mesalamine) for active mild-to-moderate ulcerative colitis, Shire PLC announced.

ATLANTA -- For the second year in a row, the absolute number of cancer deaths edged downward in the United States, the American Cancer Society said today.

GAITHERSBURG, Md. -- Despite the sturm and drang over the thrombosis threats posed by the two first generation drug-eluting coronary stents, there is unflagging enthusiasm for new and improved devices.

GAITHERSBURG, Md. -- Although the problem of stent thrombosis has been acknowledged, it is not at all certain what the circumstances are that trigger formation of a thrombus.

GAITHERSBURG, Md. -- The issues surrounding drug-eluting coronary stents remain white hot. The core question is whether they will emerge, in the end, as a great boon to coronary patients or as a lethal insult of major magnitude.

WINSTON-SALEM, N.C. -- Cells harvested from amniotic fluid express embryonic and adult stem cell markers, researchers here reported.