Another Cox-2 inhibitor is about to hit the market. In upcoming months, Novartis AG will begin selling Prexige, a Cox-2 inhibitor, across Europe, and they have also completed clinical drug trials to resubmit the drug for U.S. Food and Drug Administration (FDA) approval later this year. Novartis plans to have Prexige on the U.S. market by the first half of 2008.
A Philadelphia jury found Wyeth, the manufacturer of the hormone-replacement therapy Prempro, responsible for a 60-year-old Arkansas woman’s breast cancer. Wyeth was ordered to pay $1.5 million in compensatory damages to the plaintiff and her husband.
Teenagers are bombarded with the message that drinking and driving is dangerous, but are they also aware of other driver distractions that can be just as deadly? Research shows that a teen driver riding with one other passenger faces double the risk of a fatal car crash as a teen driver who drives alone. The risk increases to five times as likely for teen drivers with two or more passengers.
Pending approval of Congress, the user fees that pharmaceutical companies pay to the Food and Drug Administration (FDA) to review their products may substantially increase. The fee increase would allow the agency to allocate more money for the monitoring of the safety of drugs after going on the market, in addition to and a new fee for the oversight of television drug ads.
For years, there has been mounting evidence that vitamins, minerals, essential oils, herbs, and dietary supplements may not be as safe as originally believed. Since 1983, the American Association of Poison Control Centers has received over 1.6 million reports of adverse reactions from dietary supplements, including 251,799 reactions that required hospitalization and 257 deaths.
Thinking about giving your sick toddler or baby cough or cold medicine to relieve their suffering? Think again. The U.S. Centers for Disease Control and Prevention is warning parents to not administer over-the-counter cold medicine to children ages two or under.
Pergolide and cabergoline, two drugs used to treat Parkinson’s disease, are directly linked to an increased risk of heart-valve damage, according to two recently published articles in the New England Journal of Medicine.
The Food and Drug Administration (FDA) warns of a serious risk associated the drug Rituxan. Two patients that were treated with the drug for systemic lupus erythematosus (SLE) contracted progressive multifocal leukoencephalopathy (PML), a fatal viral infection that attacks the central nervous system.