8.6 C
New York
Sunday, May 9, 2021

New Evidence of Risk in Ultrasound Therapy

- Advertisement -
- Advertisement -

Covidien, a company that supplies a class of products used in echocardiography, has released new information on its use of drugs in the medical history of 1,210 patients exposed to ultrasonic defibrillation (C-19). Of these patients, 126 died. Patients in this group would be roughly 34 percent more likely to have died after undergoing C-19 therapy than those in the control group.

The Covidien study was the first of three trials that funded by the FDA. The Covidien trial was considered small and therefore small comparisons were made between the groups. In this trial, the participants were 116 patients aged 17 years or older who had undergone transcatheter mitral valve replacement surgery (TMMR) or within the first week after the surgery.

In April 2010, after the lead author of the study, Elizabeth Kauffman, met with FDA officials, it became evident that the FDA would request additional information, such as data on previous cycles of C-19 therapy and on side effects related to C-19. In the review, FDA officials also found that the study’s principal investigators may have committed misleading statements to treat the study as a small-risk study.

While the FDA initially recommended that Covidien return to the study for a follow-up, FDA staff encouraged the company to move forward with a consultation with a specialty cardiac device registrar about whether they would need to re-do the study.

Read the rest of the story from New York Times

- Advertisement -

Latest news

It’s not surprising there are drug problems

WALTHAM, Mass. — Endurance of substance abuse is in many ways an attribute of a horse who has won a Triple Crown — like...
- Advertisement -

Vaccinations fell among Europeans from the early 2000s to the present, despite significant gains in recent years

File photo of infants receiving a measles vaccination against measles at a slum near the northern Mexican city of Coatzacoalcos, April 29, 2014. Turkey...

Health officials halt naloxone use due to low demand

U.S. states have turned down hundreds of thousands of doses of a drug used to stop the fatal effects of an opioid overdose because...

‘No question, we can do better’: How to overcome the stigma of experiencing traumatic events

A year ago on this same date, a nation was first rocked by the Department of Justice’s charge that far too many African-Americans —...

Related news

It’s not surprising there are drug problems

WALTHAM, Mass. — Endurance of substance abuse is in many ways an attribute of a horse who has won a Triple Crown — like...

Vaccinations fell among Europeans from the early 2000s to the present, despite significant gains in recent years

File photo of infants receiving a measles vaccination against measles at a slum near the northern Mexican city of Coatzacoalcos, April 29, 2014. Turkey...

Health officials halt naloxone use due to low demand

U.S. states have turned down hundreds of thousands of doses of a drug used to stop the fatal effects of an opioid overdose because...

‘No question, we can do better’: How to overcome the stigma of experiencing traumatic events

A year ago on this same date, a nation was first rocked by the Department of Justice’s charge that far too many African-Americans —...
- Advertisement -