Experimental drug could replace burdensome anti-stroke treatment warfarin

An experimental blood thinner called rivaroxaban is at least as good at preventing strokes as the old warhorse warfarin, which has been used for decades in people with erratic heartbeats, researchers said Monday. The medicine also sharply reduces the risk of major bleeding that is seen with warfarin.


Rivaroxaban and the freshly approved Pradaxa offer alternatives to the widely used warfarin, which frequently has unforeseeable interactions with food and people of certain genetic types and requires monthly laboratory tests to ensure safety.


An estimated 2.3 million Americans suffer from atrial fibrillation, in which the heart beats erratically and cannot pump blood effectively, causing blood clots to form. Most people with atrial fibrillation could benefit from the new drugs, experts said, and analysts estimate the market for drugs in this class could top $20 billion a year.

Bone drugs get new fracture-risk warning

The FDA's review of bone-drug safety turned up enough evidence for a new warning about the risk of a rare-but-serious fracture of the thigh bone. There's been talk about a link between fractures and the popular class of osteoporosis drugs, known as bisphosphonates, for some time. But this is the first time FDA has required a new warning for the drugs' labels.

The warning will be added to those bone drugs approved for osteoporosis, whether oral--such as Merck's Fosamax, Roche and GlaxoSmithKline's Boniva, and Warner Chilcott's Actonel and new drug Atelvia (a next-generation version of Actonel)--or injectable, such as Novartis' Reclast. It won't apply to bisphosphonates marketed for cancer patients or Paget's disease, such as Novartis' Zometa.

FDA is asking doctors to keep a close eye on patients who've used bisphosphonates for longer than five years, because the fracture risk appears to be related to long-term use. The agency is continuing its safety review of long-term use of the drugs; so far, a causal link between the drugs and fractures hasn't been proven. Meanwhile, European regulators recently launched their own probe of the drugs and their possible link to stress fractures.

Reuters notes that the FDA warning could inspire patients to switch to Amgen's new bone drug, Prolia, which isn't a bisphosphonate. One analyst notes that Prolia sales could get a bump as early as next quarter. "Today's label change is likely to raise the level of concern among patients about the safety of bisphosphonates significantly," Bernstein & Co.'s Geoffrey Porges says in a research note.

Sabril Approved to Treat Infantile Spasms

Boston (DbTechNo) - The FDA (Food and Drug Administration ) have just approved a drug to treat infantile spasms in children.

The drug, Sabril is made by H Lundbeck A/S and is approved for children as young as 2 and is also approved for use by adults.

Sabril is the first drug to be approved in the US for treating infantile spasms.

Infantile spasms generally present during the first 8 months of life and can be very hard to handle due to their frequency.

The drug is already approved in other countries to treat the condition.

It will however come with a blackbox warning because of vision problems that have been documented in clinical studies of it.

Source: http://www.dbtechno.com/health/2009/08/22/sabril-approved-to-treat-infantile-spasms/