Latest pharmacy news

Antiplatelet drugs, PPIs can be simultaneously prescribed to heart patients, investigators say.

According to Bloomberg News (9/1, Cortez), approximately "two million people worldwide undergo procedures to clear heart arteries each year, then take aspirin plus Plavix [clopidogrel] or Effient [prasugrel] from Eli Lilly & Co. and Daiichi Sankyo Co. to prevent re-clogging." What's more, these patients are "routinely prescribed pills" like Nexium [esomerprazole magnesium] or Prilosec [omeprazole], which are proton-pumps inhibitors (PPIs), "to reduce...stomach acid at the same time, since the other medications can cause gastrointestinal trouble." There have been "concerns that mixing the medications may reduce the effectiveness of" the "blood thinner."

Dow Jones Newswires (9/1, Favole) notes that "earlier this year, the FDA asked Plavix marketers Bristol-Myers and Sanofi to update the drug's label to warn of risks with the drug when used in combinations with PPIs." But new research by Brigham and Women's Hospital appears to contradict earlier studies.

For the study appearing online in The Lancet, WebMD (8/31, Boyles) reported, investigators analyzed the results of two trials -- TRITON-TIMI 38 and PRINCIPLE-TIMI 44 -- with the "larger of the two" including "about 13,600 patients who had a previous heart attack or unstable angina treated with one of the two drugs." One-third of the participants "were also taking a PPI, but PPI use was not found to be associated with an increased risk of a second heart attack, stroke, or cardiovascular death with either of the two anti-clotting drugs."

But "evidence of the pharmacodynamic effect of the PPI-thienopyridine interaction was clear in data from the PRINCIPLE trial,"MedPage Today (8/31, Peck) pointed out. Ralph G. Brindis, MD, MPH, President-elect of the American College of Cardiology, said that "even though there is evidence in the test tube that inhibition of platelet aggregation is diminished with PPI therapy, there is no clinical effect." The new findings should not "be construed as a signal to return to routine prophylaxis with PPI," he added. "But for high risk patients who need these drugs, I think we can be a little more confident using PPIs." Reuters (9/1, Hirschler) also covers the story.

Drug Approvals

FDA approves Valcyte to prevent cytomegalovirus in young kidney, heart transplant patients.

The AP (9/1) reports, "Roche said Monday the Food and Drug Administration approved Valcyte [valganciclovir hydrochloride] to prevent the common cytomegalovirus in children who have received kidney or heart transplants." Valcyte "is already approved to treat Cytomegalovirus Retina, an infection of the eye, in patients with AIDS," and "to prevent cytomegalovirus in kidney, heart and kidney-pancreas transplant patients at high risk."

HealthDay (8/31, Roberts) added that the FDA approved the drug for "children 4 months to 16 years who are undergoing kidney or heart transplant, Swiss drug maker Roche said Monday." Roche also said that as "part of the approval, the FDA sanctioned a new oral liquid form of the drug to allow for easier use in children."

FDA grants doxorubicin orphan drug status.

The AP (8/31) reported, "Delcath Systems Inc. said Monday the Food and Drug Administration gave its developing liver cancer treatment doxorubicin orphan drug status." The status "is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market," and allows "seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits." The AP added, "Delcath focuses on using drug delivery technology that gives ultra-high doses of anticancer drugs to the liver."

Medication Use

FDA approves six new marketable volumes, concentrations of heparin.

The AP (9/1) reports, "Drug delivery system and device maker Hospira Inc. said Monday it received Food and Drug Administration approval to market the blood thinner heparin in six new volumes and concentrations." The doses "range from one milliliter to 30 milliliters in size," according to Hospira, and the "concentrations range from 1,000 units per milliliter to 10,000 units per milliliter." The AP adds, "The approval covers three single-dose vials and three multiple-dose vials."

Quality and Safety

Flu shot focus may be overshadowing necessity of meningococcal meningitis vaccination, experts say.

The AP (9/1) reports that although it can often initially seem "like a stomach bug or the flu," bacterial meningitis "can go on to kill terrifyingly fast." And, the "prime targets are tweens, teens and college freshmen." But there are concerns that the onslaught of flu shot headlines may be overshadowing the need to seek "vaccination against meningococcal meningitis." In the "two years since the government recommended that every adolescent be vaccinated, close to 40 percent of tweens and teens are." But while there "are multiple types of meningitis," nearly "15 percent of the people who catch this fast-moving germ die -- and one in five of the survivors --suffer permanent disabilities including brain damage, deafness or amputated limbs." So, many universities "now require freshmen to be vaccinated, whether they're dorm-dwellers or not." What's more, "a growing number of states are passing legislation making a meningococcal shot a requirement to enter certain grades."