FDA Sends Warning Letters To Stem Cell Clinics After A Dozen Patients Became Seriously Ill From Injections
There's a stem cell clinic boom happening across the country, but the businesses and their practices are highly unregulated and can be dangerous. The FDA is planning on ramping up oversight of such facilities.
The Associated Press:
Stem Cell Shots Linked To Bacterial Infection Outbreak
Health officials on Thursday reported an outbreak of bacterial infections in people who got injections of stems cells derived from umbilical cord blood. At least 12 patients in three states — Florida, Texas and Arizona — became infected after getting injections for problems like joint and back pain, the Centers for Disease Control and Prevention said. All 12 were hospitalized, three of them for a month or longer. None died. (Stobbe, 12/20)
The New York Times:
12 People Hospitalized With Infections From Stem Cell Shots
The F.D.A. said on Thursday that it had also written to 20 clinics that offer unapproved stem cell treatments, warning them that such products are generally regulated by the agency and encouraging the clinics to contact federal regulators before November 2020, when enforcement will tighten. The names of the clinics have not been released. “We’re going to be going in and inspecting more stem cell operators this year,” Dr. Scott Gottlieb, the agency’s commissioner, said in an email. “We’re focused on outfits that may be engaging in unsafe practices and haven’t been working with F.D.A. to come into compliance with the laws they’re subject to. Unfortunately, there are too many firms that fit this description.” (Grady, 12/20)
The Washington Post:
FDA Warns Stem-Cell Company Linked To E. Coli Infections
A year ago, the agency issued a “regulatory framework” spelling out the rules on stem-cell products and procedures. And it said it would exercise “enforcement discretion,” giving companies until November 2020 to comply — as long as they don’t pose safety risks to patients. The for-profit, direct-to-consumer stem-cell industry started in other countries but has grown rapidly in the United States. Today, several hundred clinics sell therapies to treat conditions as varied as arthritis, Parkinson’s disease and multiple sclerosis. Some sell stem cells derived from the patients' own blood, fat or bone marrow, while others use stem-cell products manufactured by outside suppliers. (McGinley, 12/20)
CNN:
Infections Put 12 People In Hospitals After They Received Unapproved Stem Cell Products
"We see a lot of promise from stem cell treatments, but we also have a lot of concern, and we started by sending these 20 letters singling out these firms that should be engaging with FDA but haven't been," FDA Commissioner Dr. Scott Gottlieb said. "In addition, we are also stepping up our inspections this year. We are concerned that there are firms whose actions could be putting patients at risk and might be subject to additional action." (Christensen, 12/20)
In other FDA news —
CNN:
Certain Antibiotics May Cause Aortic Aneurysm, FDA Warns
The US Food and Drug Administration warned on Thursday that the benefits of fluoroquinolone antibiotics do not outweigh the risks -- which include aortic aneurysm -- for certain patients, according to the latest research. The research is based on reports of patient problems and on studies published between 2015 and 2018. (Christensen, 12/20)
