opioids Archives - Mediarabe

Was FDA Lax in Approving Opioids Too Easily? | Health News

September 30, 2020

By Dennis Thompson
HealthDay Reporter

(HealthDay)

WEDNESDAY, Sept. 30, 2020 (HealthDay News) — For at least two decades, the U.S. Food and Drug Administration has been approving new formulations of prescription opioids without requiring drug manufacturers to gather important information on safety and effectiveness, a new study claims.

The FDA approved dozens of these highly addictive medications for treatment of chronic pain between 1997 and 2018 based on clinical trials that:

Lasted no longer than 12 weeks,
Failed to systematically gather data on adverse events or safety concerns,
Actually weeded out of the final results from people who didn’t initially respond well to the drug.

“No trial was longer than 84 days, whereas people take these medicines for years and they’re labeled for chronic use,” said senior researcher Dr. G. Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health

Older Patients at Risk When Dentists Prescribe Opioids | Health News

September 28, 2020

| No Comments

| Health

By Robert Preidt, HealthDay Reporter

(HealthDay)

MONDAY, Sept. 28, 2020 (HealthDay News) — Seniors who take depression and anxiety drugs shouldn’t be prescribed opioid painkillers by their dentist because it puts them at increased risk for problems, researchers warn.

They analyzed 2011-15 dental and medical data for 40,800 patients aged 65 and older across the United States. There were 947 emergency room visits and hospitalizations in the 30 days after a dental visit.

One in 10 of those who were prescribed opioids were also using medications that shouldn’t be taken with them. These patients were 23% more likely to visit the ER or require hospitalization within a month of the dental visit where they received the opioid prescription, the study found.

The longer they took the painkillers, the greater their risk. Those whose opioid prescription overlapped with their existing non-compatible medication for more than three days were 47% more likely

FDA approved opioids for chronic pain despite lacking ‘critical’ safety data, analysis finds

September 28, 2020

| No Comments

| Health News

Sept. 28 (UPI) — The U.S. Food and Drug Administration approved nearly 50 new prescription opioid pain medications between 1997 and 2018, even though it lacked “critical” data on safety and effectiveness, an analysis published Monday by the journal Annals of Internal Medicine found.

None of the 48 drugs granted agency approval during the more than 20-year period was evaluated in clinical trials that lasted longer than 12 weeks, and the trials often included narrowly defined groups of patients, researchers said.

And few included “systematic assessments” of risks associated with these medications, including addiction potential and non-medical use.

“Our analysis provides a window through which to view the FDA’s opioid regulation over the past 20 years,” study co-author Dr. Caleb Alexander, founding co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health, told UPI.

“We found the FDA often approved new opioids based

M	T	W	T	F	S	S
1	2	3	4	5	6	7
8	9	10	11	12	13	14
15	16	17	18	19	20	21
22	23	24	25	26	27	28