FDA issues safety risk for HIV drug
ROCKVILLE, Md. A rare but serious liver disorder has been reported in some patients taking a drug used to treat HIV, the Food and Drug Administration said Monday.
The agency said some patients taking Bristol-Myers Squibb’s antiretroviral drug Videx (didanosine) and the extended-release formulation, Videx EC, had experienced non-cirrhotic portal hypertension, in which blood flow in the liver’s portal vein slows down and leads to severely enlarged veins in the esophagus. The enlarged veins, called esophageal varices, can then break open, causing serious and potentially fatal bleeding.
Over an 18-year period, 42 cases of the condition, including four deaths, have been reported in patients taking the drug. The FDA approved Videx in 1991 and Videx EC in 2000. Still, the agency said, the benefits of the drug outweigh the risks.
In a statement obtained by Drug Store News Monday, Bristol said it had updated the safety information for the drugs and created a risk evaluation and mitigation strategy, or REMS, which the agency had required.
“Bristol-Myers Squibb is committed to understanding both the efficacy and safety profiles of our medicines,” the company said in the statement.
Lupin receives FDA approval for hypertension generic
BALTIMORE The Food and Drug Administration has given approval to a generic version of a drug used to treat high blood pressure made by an Indian drug maker.
Lupin Pharmaceuticals announced Thursday that it had received approval for perindopril erbumine tablets, used to treat essential hypertension and management of coronary artery disease.
The drug is a generic version of Solvay Pharmaceuticals’ Aceon, which had sales of $24 million during the 12-month period ending in September 2009, according to IMS Health.
Loose ends should be tied to make e-prescribing a reality
WHAT IT MEANS AND WHY IT’S IMPORTANT Relative to the national chains, independent pharmacies have limited resources and, given the importance and benefit of e-prescribing, further helping to facilitate the adoption of e-prescribing via grants — not to mention facilitating two-way communication between prescribers and pharmacists — is critical to help push overall adoption closer to the finish line.
THE NEWS: (NCPA: E-prescribing should be more efficient in two-way communication, cost. For the full story, click here)
As stated in the article, the National Community Pharmacists Association, at a recent e-prescribing committee, recommended providing grants to offset implementation and transaction fee costs and making two-way communication between prescribers and pharmacists easier.
In written testimony at a hearing of the Department of Health and Human Services’ Health Information Technology Policy Committee Information Exchange Workgroup, the NCPA acknowledged that community pharmacists have a vested interest in making e-prescribing work but yet cost challenges remain.
E-prescribing has been praised especially in recent years as it has been shown to increase the likelihood that patients will get their prescriptions filled and, in turn, avoid more expensive medical procedures. There’s also less of a chance for errors compared with paper prescriptions.
E-prescribing has achieved impressive milestones in recent years but the journey is far from over. In October 2009, e-prescribing network provider Surescripts announced that 23% of all office-based physicians, nurse practitioners and physician assistants in the United States are now e-prescribing. At that rate, Surescripts projected that its total number of active e-prescribers in 2009 would more than double the 74,000 active e-prescribers at the end of 2008.