FDA warns patients about asthma drug risks
ROCKVILLE, Md. Drugs belonging to the class called long-acting beta agonists should never be used alone for treating asthma in patients and should be combined with other asthma drugs, according to a new warning by the Food and Drug Administration, which is requiring that pharmaceutical manufacturers add the warning to the drugs’ product labels.
The FDA conducted an analysis of clinical trials showing that use of the drugs can increase risk of severe worsening of asthma symptoms, requiring children and adults to be hospitalized and sometimes resulting in death. Instead, the agency said, the drugs should be used only in combination with asthma controller medications such as inhaled corticosteroids, and should only be used long term in patients whose asthma is not adequately controlled by asthma controller medications, but should otherwise be used for the short term.
The drugs used in the analysis, also known as LABAs, include GlaxoSmithKline’s Serevent (salmeterol xinofoate) and Foradil (formoterol fumarate), made by Novartis and Schering-Plough Corp. –– now part of Merck & Co. –– as well as combination LABA-inhaled corticosteroid drugs such as AstraZeneca’s Symbicort (budesonide and formoterol fumarate dihydrate) and GlaxoSmithKline’s Advair (fluticasone propionate and salmeterol).
“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death,” FDA Center for Drug Evaluation and Research Division of Pulmonary and Allergy Products director Badrul Chowdhury said.
Duane Reade opens fifth walk-in medical clinic in New York
NEW YORK A new walk-in clinic at a Duane Reade store in Chelsea officially opened on Wednesday, making it the fifth Duane Reade location with “Doctor on Premises” walk-in medical care.
The physician-staffed clinic is managed by Consumer Health Services and is also affiliated with Beth Israel Medical Center and St. Luke’s-Roosevelt Hospital Center. It is open Monday through Saturday, 10 a.m. to 6 p.m., and accepts most insurance plans.
“Walk-in, neighborhood-based medical care is a growing trend in this country, and it’s a very positive trend,” stated Dr. Maggie Bertisch, M.D., medical director for New York Walk-In Medical Group PC. “It allows healthcare providers to offer a more convenient, affordable alternative to crowded emergency rooms, while delivering safe, quality medical care in a New York minute.” According to CHS, Duane Reade is planning to add more on-site health clinics in 2010.
As reported, Walgreens, which owns retail-based clinic operator Take Care Health Systems, announced on Wednesday that is has reached an agreement to buy Duane Reade in a deal valued at nearly $1.1 billion.
Hi-Tech Pharmacal, Mission Pharmacal to market new kidney stone treatment
AMITYVILLE, N.Y. Hi-Tech Pharmacal and Mission Pharmacal Co. are planning to market a new treatment for kidney stones to doctors starting in April, the drug maker announced Wednesday.
Under a license agreement between the two companies, Hi-Tech will promote UroCit-K 15mEq (potassium citrate) extended-release tablets to primary care physicians through subsidiary ECR Pharmaceuticals, while Mission will promote it to urologists. The drug is a twice-daily treatment.
“We are pleased to introduce another unique prescription branded product to the primary care market,” Hi-Tech president and CEO David Seltzer said in a statement. “UroCit-K 15mEq is a highly effective product, available in a convenient dosing regimen which will increase patient compliance.”