Roundup: FDA Warns of Overdoses from ‘Dosing Errors’ When Injecting Weight-Loss Drugs; And More News

FDA: Dosing Errors have Led to Serious Overdoses of Popular Weight-Loss Injectable Drugs

The U.S. Food and Drug Administration (FDA) has issued an alert regarding reports of people accidentally overdosing on popular weight-loss injectable drugs, some requiring hospitalization. The FDA states that the overdoses are mostly due to dosing errors associated with compounded semaglutide injectable products.

Demand is still surging for “weight-loss” medications sold under different brand names, such as Wegovy and Ozempic, that contain the drug semaglutide in the form of injections. Compounded semaglutide products come in various containers and packaging, including multiple-dose vials and prefilled syringes

“Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and healthcare providers miscalculating doses of the drug,” the FDA states in its report. “FDA encourages patients to talk with their healthcare provider or compounder about how to measure and administer the intended dose of compounded semaglutide.”

Semaglutide falls under a class of medications known as “glucagon-like peptide 1” (GLP-1) – and it is part of therapy already established for the management of type 2 diabetes, also resulting in some weight reduction and favorable management of heart disease.

Many of the patients who received vials of compounded semaglutide “lacked experience with self-injections, according to the adverse event reports,” the FDA states.

“Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams and “units”) may have contributed to dosing errors,” the FDA states.

Adverse effects from overdoses of compounded semaglutide include severe nausea, severe vomiting and severe hypoglycemia (low blood sugar levels). A prolonged period of observation and treatment for overdose symptoms may be necessary due to the long half-life of semaglutide of about one week, the FDA states.

American Heart Association: Some Middle-Aged Adults with Blocked Leg Arteries Face High Risk of Amputation

A new study published in the American Heart Association journal Circulation finds that some middle-aged adults need early detection and treatment of peripheral artery disease, or PAD, because they may have a higher risk of leg amputations than older adults.

Peripheral artery disease, or PAD, occurs when plaque builds up in the arteries that carry blood from the heart to other parts of the body, restricting proper blood flow. Most often, this occurs in the legs and the feet, though it can also affect the arms, hands and fingers. The condition can lead to amputations and death.

Several types of surgery involving “lower limb revascularization” can restore blood flow to the legs. PAD treatments include: Angioplasty and/or stenting; surgical bypass; medications; and supervised exercise therapy. Angioplasty involves a tiny balloon that is inflated inside the arteries to clear away plaque, and can be followed by inserting stents that hold the arteries open.

"This study shows that early diagnosis and treatment are of vital importance for people with PAD," said Qiuju Li, M.D., the study's lead author and a research fellow in medical statistics at the London School of Hygiene and Tropical Medicine, in a statement. "People under 60 with severe forms of PAD have particularly poor outcomes. Better preventive strategies are warranted."

In the new study, researchers reviewed data for 94,690 people in England who underwent revascularization for PAD from 2013 to 2020. Participants were 50 or older, and about 65 percent were men.

“Nearly 35 percent of the participants had nonelective surgery, meaning it was considered medically necessary,” states a news release from the American Heart Association (AHA). “The remainder elected to have surgery to restore blood flow. Compared with those who had elective surgeries, people who had nonelective revascularizations tended to be 80 years or older, frailer and more likely to have diabetes and tissue loss.”

The risk of amputation, however, was higher among younger adults whose revascularizations were medically necessary, the AHA stated. Participants between ages 50 and 54 carried an 18 percent risk of a major amputation after one year, and 28.8 percent after five years.

The risk for those ages 80 to 84 was 11.9 percent after one year, and 17 percent after five. For people who chose to have the surgery, the risk of major amputation stayed comparatively low regardless of age.

One At-Home Screening Option Reduces Risk of Death from Colorectal Cancer by 33%, New Study Finds

A new study has found a 33 percent reduced risk of dying of colorectal cancer for those taking at least one fecal immunochemical test (FIT) screening, a noninvasive screening that can be carried out at home

The analysis of Kaiser Permanente patients in California included 10,711 people, between ages of 52 and 85, who completed a FIT screening through a Kaiser Permanente medical center in Northern and Southern California. The researchers “compared 1,103 people who died from colorectal cancer with 9,608 other patients who were similar but did not have a colorectal cancer diagnosis when screened,” states a news release from Kaiser Permanente.

The analysis, published in JAMA Network Open, found 63.5 percent of patients in the study completed one or more FITs. Of the 12.6 percent who had a positive result, 79 percent came in for a colonoscopy. The study found a greater risk reduction for cancers identified in the left colon and rectum.

Of all the colon cancer screenings, the colonoscopy is still the No. 1 recommended procedure, especially for those at above average risk for colorectal cancers. There is also a “virtual colonoscopy” option for those who don’t want to go through an invasive test.

Moreover, there are basic at-home screening kits available for colorectal cancers — the fecal occult blood test (FOBT); the fecal immunochemical test (FIT), and the stool DNA test. If these tests come back positive, a colonoscopy is generally recommended.

If you are between the ages of 45-50, it is important to talk with your doctor about colon cancer screenings.

“Colorectal cancer screening works and is one of the best ways of decreasing deaths from colorectal cancer,” said Douglas Corley, M.D., Ph.D., a co-principal investigator, research scientist with the Kaiser Permanente Division of Research, and chief research officer for The Permanente Medical Group. “This study — of at least one FIT screening in the previous few years — confirms this method is an effective tool.”