The health officials of government are investigating the cases that involve patients who had suffered complications when they were injected with the medications which were potentially contaminated and made by Tennessee pharmacy.
The Food and Drug Administration on Friday said that the problems are with 7 patients who were injected with steroids from Main Street Family Pharmacy which is compounding pharmacy located in Newbern in Tenn.
The health officials of Tennessee said that the pharmacy agreed to have all its products, which are sterile, recalled and which generally are injectable prescriptions. The FDA officials and health department of Tennessee have continued to inspect this pharmacy since this Wednesday.
State regulators remarked that the staff of pharmacy and the management had been cooperative.
One employee who was approached at the Main Street Family Pharmacy at noon on Friday couldn’t provide comment immediately.
These injections have methylprednisolone acetate, same drug which was at centre of the fungal meningitis deadly outbreak last year. Above fifty people have lost their lives and more than 740 others got sick when they received contaminated injections through a compounding pharmacy at Massachusetts. Typically the steroids are used for treating pain.
The federal authorities identified about 5 cases within Illinois and 2 others in North Carolina. 5 patients in Illinois got buttocks and hips skin infections while at minimum, 1 patient has fungal infection in North Carolina, according to Centers for Disease Control and Prevention.
Joseph Perz, the health-care epidemiologist who is assisting in leading CDC’s investigation said that there isn’t indication of meningitis or any life-threatening infection at present.
FDA recommends that the doctors should stop the use of sterile drugs are from this pharmacy at an immediate basis.
Being compounding pharmacy means that Main Street Family Pharmacy mixes custom drugs formulations based on specifications by doctors. Such type of pharmacies has operated for quite a time in a gray legal area which is between federal and state regulations. Since the outbreak last year, FDA stepped up the inspections of these pharmacies throughout the country, stimulating many national recalls related to medications that are potentially contaminated.
The Tennessee Health Department said that it is very early to inform about the number of people who have received these injections while under scrutiny. The records of pharmacy show that this drug got shipped to the medical facilities of 13 states: Texas, Illinois, Tennessee, Arkansas, Alabama, Florida, Kentucky, South Carolina, North Carolina, New Mexico, Mississippi, Louisiana and California.
The Pharmacy got licensed by Tennessee Board of Pharmacy in the year 1985 and licensed it as a distributor and manufacturer later, in 2010.
Pharmacies like these are been overseen from a long time by the pharmacy boards of state, with the regulations widely different for each state. In the last twenty years, some of the compounding pharmacies grew to large businesses, operating much like manufacturers through shipping loads of drugs’ doses across the state lines. FDA occasionally tried asserting authority over such operations, but it repeatedly has been challenged by the pharmacy owners in court.
The legislation that is moving through the Congress will give FDA a direct oversight of the compounding manufacturers, having the aim to prevent future outbreaks at a national level tied to the compounded medications. No agreement has been reached by the House, even though Democrats and Republicans in Senate have happened to coalesce around some bill.