FDA OKs 1st Lupus Drug in 50 Years

Pharmaceutical companies trying to protect themselves from litigation

(NEWSER) - Take a gander at your typical prescription drug label, and you’ll see a lot more side effects than even the fastest talker could rattle off at the end of a commercial. The average label warns of a staggering 70 side effects, according to a new study that reviewed 5,600 such labels. But that’s mostly because drug makers want to protect themselves from every possible lawsuit, rather than because of real dangers, researchers tell Live Science . More»

Drugs declared 'safe' on basis of unregulated trials abroad

(NEWSER) - Prescription drugs that are considered safe kill an estimated 200,000 Americans a year, and investigative reporters Donald L. Barlett and James B. Steele have exposed a massive loophole that could help explain why. Some 6,485 clinical trials were conducted abroad in 2008—more than 20 times as many as in 1990—and the FDA has been declaring drugs safe based on foreign trials that are almost completely free from regulation or oversight, a detailed investigation published in Vanity Fair finds. More»

Popular painkillers cause abnormal heart rhythms

(NEWSER) - The painkillers Darvon and Darvocet are being pulled off the prescription drug market because they can trigger potentially fatal heart rhythm abnormalities, CNN reports. The FDA requested that the drug behind both popular brands, propoxyphene, be yanked after a trial study found the side effect. "The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks," says the FDA. More»

But regulators stop short of an outright ban on Avandia

(NEWSER) - The FDA today put severe restrictions on Avandia, GlaxoSmithKline’s embattled diabetes drug, but stopped short of banning it outright. The once-popular drug will now only be available only as a last resort to type 2 diabetes patients who can’t control their glucose levels with any other medication, the AFP reports. Avandia has come under fire because data suggests it carries, in the FDA’s words, “an elevated risk of cardiovascular events” like heart attacks and strokes. More»

(NEWSER) - A federal judge today ordered the Food and Drug Administration to immediately relax age restrictions on the morning-after contraception pill, and reconsider whether there should be any restrictions at all, the Washington Post reports. Since 2005, the pill has been available without a prescription only to women over 18; within 30 days, that age must be 17, the judge ordered. More»