FDA may withdraw low blood pressure drug approval
SILVER SPRING, Md. The Food and Drug Administration may rescind its approval of a drug used to treat low blood pressure, saying that companies marketing it have failed to provide evidence of its clinical benefit.
The FDA said Monday that it might withdraw approval of the drug midodrine hydrochloride, used to treat orthostatic hypotension, a condition that renders patients unable to maintain blood pressure when upright, causing them to become dizzy or faint when standing. According to the agency, it would be the first such notice for a drug approved under its accelerated approval regulations.
The drug is widely available in generic form, having originally won approval under the FDA’s accelerated approval program in 1996 as the branded drug ProAmatine, made by Shire Development. One condition for the accelerated approval was that Shire had to demonstrate its clinical benefit in post-approval studies. But to date, the FDA said, neither Shire nor generic manufacturers has demonstrated that the drug has clinical benefits, such as improving a patient’s ability to perform various activities.
The FDA said it would provide an opportunity for a hearing to Shire and the generic companies. Apotex Corp., Impax Labs, Mylan, Sandoz and Upsher-Smith Labs make generic versions of the drug. The agency said Shire would have 15 days to request a hearing, while the generic companies would have 30 days to submit written comments on the notice.
Arepresentative of Shire could not be reached for comment.
East Harlem walk-in asthma center opens
NEW YORK Mayor Michael Bloomberg and Manhattan borough president Scott Stringer have announced the opening of a new asthma walk-in center in East Harlem, where the rate of childhood asthma hospitalizations is the highest in the city.
The new East Harlem walk-in asthma center — an expansion of the East Harlem Asthma Center of Excellence and a part of the City’s PlaNYC initiative — is aimed to reduce childhood asthma hospitalizations by 50% over the next five years.
The center is one of the key initiatives of Stringer’s Go Green East Harlem, a collaborative community-based initiative that has focused on five core areas: public health and healthy food, parks and open space, sustainable business, transportation, and green building.
The walk-in center staff worked out of the East and Central Harlem District Public Health Office before the new space was completed. The $3.5 million project included $700,000 from the Manhattan borough president’s office. The Department of Citywide Administrative Services provided site selection and project management services for the construction.
The new walk-in center will offer a number of asthma-related services, including on-site asthma assessments, individual and group asthma education, social support services, one-on-one asthma counseling, linkage to services to rid homes of asthma-triggering pests and mold and referrals for medical care. The walk-in center will also include a library with educational materials and computers with Internet access to help families learn the best strategies to manage asthma.
More than 25% of the children in East Harlem have asthma, and East Harlem has the highest rate of childhood asthma hospitalizations in the city. In 2008, 11-of-every-1,000 East Harlem children ages 14 years and younger were hospitalized. In 2008, Stringer and the Health Department’s East and Central Harlem District Public Health Office founded the East Harlem Asthma Center of Excellence to address the issue.
Stew Leonard’s offers employees on-site physicals
NORWALK, Conn. Stew Leonard’s recently brought into its Yonkers store nurses and doctors from Inter-State Diagnostic to conduct on-site physicals for its team members as part of its commitment to preventive health care, the company announced.
The program kicked off Aug. 2 with 24 associates receiving their annual physical performed by a medical team with Inter State Diagnostic. The associates reported to a conference room above the store for blood work, an EKG and complete physical. Inter-State Diagnostic’s doctors and nurses provided privacy screens and all necessary medical equipment, and met with each team member regarding their healthcare-related questions. A translator for Stew Leonard’s Spanish-speaking employees also was on hand.
On-site physicals are the latest example of how the grocer has taken an active approach to preventive health care for its more than 2,500 employees. On-site cholesterol and blood pressure screenings, mammograms and flu shots are offered throughout year and discounts on weight-loss programs, smoking cessation aids, and fitness center memberships also are provided to both full and part-time team members. In addition, through Aug 31, Stew Leonard’s will give team members up to $500 in Benefit Bucks or money toward their deductible to encourage them to visit their doctor for their annual checkup.