Peggy Peck

LONDON -- The editors of The Lancet have cautioned against a rush to judgment in the face of a meta-analysis released Monday that linked the diabetes drug rosiglitazone (Avandia) to a 43% increase in relative risk of myocardial infarction.

ROCKVILLE, Md. -- The FDA today ordered black-box warnings for all gadolinium-based contrast agents for magnetic resonance imaging, detailing an increased risk for nephrogenic systemic fibrosis with kidney-disease patients.

ROCKVILLE, Md., May 23 -- The FDA has approved the first continuous-use oral contraceptive for prevention of pregnancy -- a pill that will eliminate a woman's monthly menstrual cycle.

The American College of Cardiology Board of Trustees said today that it would bar Martin Leon, M.D. of Columbia University from participation "as a presenter, reviewer, or panelist" at its 2008 meeting. The sanction, which was recommended by the ACC's ethics committee, was a response to Dr. Leon's premature disclosure of the embargoed findings of the COURAGE trial, which led to the "consequent premature lifting of the embargo". Related article: COURAGE Embargo Break: Slip of the Tongue or Sabotage?

BOHEMIA, N.Y. -- A maker of shark cartilage capsules has issued a nationwide recall after routine product testing revealed potential Salmonella contamination.

BALTIMORE -- Medicare has reacted to an FDA black box on erythropiesis stimulating agents by drawing a red line on the coverage of treatment for cancer patients.

ROCKVILLE, Md. -- The maker of oxycodone controlled-release tablets (OxyContin) has agreed to pay million in fines and civil penalties to resolve charges regarding the company's promotion of the drug as a less addictive pain-killer.

SEATTLE -- Immunogenicity from the live attenuated herpes zoster vaccine (Zostavax) -- unlike herpes -- is not forever, post-marketing data suggest.

ABBOTT PARK, Ill. -- A heart failure drug called levosimendan (Simdax), which has been in clinical trials, has been withdrawn from development by Abbott Laboratories and Finnish partners.

SILVER SPRING, Md. -- An FDA advisory panel has unanimously recommended accelerated approval of a novel antiretroviral drug as an add-on treatment for adult infected with CCR5-tropic HIV-1.

WHITEHOUSE STATION, N.J., April 27 -- Merck said today that the FDA has rejected the investigational Cox-2 inhibitor etoricoxib (Arcoxia) for marketing.

ROCKVILLE, Md. -- Some 300,000 home continuous positive airway pressure devices have been recalled by ResMed after short circuits from faulty wiring in electrical plugs, reported the FDA.

ROCKVILLE, Md. -- The FDA has approved the first generic versions of zolpidem tartrate, marketed for years as Ambien, for short-term treatment of insomnia.

NEW YORK -- More than half the states have tied payment to performance for Medicaid services for some of their health care programs, according to a survey just published.

BOSTON -- Hefty user fees from pharmaceutical companies account for some 40% of the FDA?s budget for new-drug reviews, but this scheme that spurs speedier approvals worries safety watchdogs.

GAITHERSBURG, Md. -- By a vote 20 to one, FDA advisers recommended today against approval of Merck's Cox-2 inhibitor etoricoxib (Arcoxia), declaring that the cardiovascular risks of the drug outweigh its benefits for easing arthritis pain.

ROCKVILLE, Md. -- The FDA and GlaxoSmithKline have warned pharmacies about a drug-tampering incident that resulted in misbranding of two drugs used to treat HIV.

ROCKVILLE, Md. -- The FDA said two reports of glass fragments in a liquid antifungal triggered a nationwide recall of griseofulvin (Grifulvin V), microsize 125 mg/5mL.

ROCKVILLE, Md. -- Guidant has recalled approximately 73,000 implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) because of a defect that shortened battery life, the FDA reported.

ROCKVILLE, Md. -- The FDA has approved the first type 2 diabetes treatment that includes a dipeptidyl peptidase-4 (DPP-4) inhibitor with metformin in a single tablet.

ROCKVILLE, Md. -- The FDA announced today that Novartis has agreed to withdraw Zelnorm (tegaserod), the only approved drug for irritable bowel syndrome (constipation), after a pooled analysis of 29 placebo-controlled, short-term trials found a small but statistically significant increase in ischemic events, including angina and stroke. The analysis identifed 13 such events, including one death, in more than 11,600 patients treated with tegaserod versus one event among a placebo group.

ROCKVILLE, Md. -- FDA advisers have recommended that the agency approve a therapeutic personalized vaccine for treatment of metastatic prostate cancer that may increase survival by several months.

ROCKVILLE, Md. -- The FDA today withdrew the Parkinson's drug pergolide -- a dopamine agonist sold as Permax and as a generic -- because of an increased risk of valvular heart disease.

NEW ORLEANS -- Among the blizzard of clinical trials to be presented at the American College of Cardiology meeting here over the next four days are 11 singled out for special treatment --simultaneous online publication in peer-reviewed journals.

ROCKVILLE, Md. -- In an effort to insulate the FDA and members of its advisory panels from suspicion of conflicts of interest, the agency said it will no longer solicit counsel from researchers who have received ,000 or more from a manufacturer with a product under review.

NEW YORK -- Minnesota and Vermont require pharmaceutical companies to disclose payments of or more to physicians and other health care providers, but both states have been accused of failing to deliver on that promise of transparency.

ROCKVILLE, Md. -- The FDA has issued a safety alert for linezolid (Zyvox) after clinical trial data suggested excess mortality when the drug was used to treat Gram-negative septicemia.

ROCKVILLE, Md. -- The FDA has approved eculizumab (Soliris), tbe first of a new class of natural immune system blockers, for paroxysmal nocturnal hemoglobinuria, a rare blood disorder that can lead to disability and death.

ROCKVILLE, Md. -- The FDA has approved a rapid test that will allow the diagnosis of viral meningitis within hours of symptoms rather than days.

MONTREAL -- White Americans still have longer life expectancies than black Americans, but the gap has narrowed in recent years, researchers here reported.