Normal view

There are new articles available, click to refresh the page.
Before yesterdayMain stream

Drugmaker shut down after black schmutz found in injectable weight-loss drug

By: Beth Mole
4 November 2024 at 23:05

The Food and Drug Administration is warning consumers not to use any drugs made by a compounding pharmacy in California after regulators realized the pharmacy was making drugs that need to be sterile—particularly injectable drugs—without using sterile ingredients or any sterilization steps.

The products made by the pharmacy, Fullerton Wellness LLC, in Ontario, California, include semaglutide, which is intended to mimic brand-name weight-loss and diabetes drugs Wegovy and Ozempic. Fullerton also made tirzepatide, which is intended to mimic weight-loss and diabetes drugs Zepbound and Mounjaro.

The FDA became aware of the problem after a patient submitted a complaint to the regulator that a vial of semaglutide from Fullerton Wellness had an unidentified "black particulate" floating in it. Semaglutide, like tirzepatide, is injected under the skin and is intended to be sterile.

Read full article

Comments

© Getty | Steve Prezant

As hospitals struggle with IV fluid shortage, NC plant restarts production

By: Beth Mole
1 November 2024 at 21:42

The western North Carolina plant that makes 60 percent of the country's intravenous fluid supply has restarted its highest-producing manufacturing line after being ravaged by flooding brought by Hurricane Helene last month.

While it's an encouraging sign of recovery as hospitals nationwide struggle with shortages of fluids, supply is still likely to remain tight for the coming weeks.

IV fluid-maker Baxter Inc, which runs the Marion plant inundated by Helene, said Thursday that the restarted production line could produce, at peak, 25 percent of the plant's total production and about 50 percent of the plant's production of one-liter IV solutions, the product most commonly used by hospitals and clinics.

Read full article

Comments

© Getty | The Washington Post

Why a diabetes drug fell short of anticancer hopes

Pamela Goodwin has received hundreds of emails from patients asking if they should take a cheap, readily available drug, metformin, to treat their cancer.

It’s a fair question: Metformin, commonly used to treat diabetes, has been investigated for treating a range of cancer types in thousands of studies on laboratory cells, animals, and people. But Goodwin, an epidemiologist and medical oncologist treating breast cancer at the University of Toronto’s Mount Sinai Hospital, advises against it. No gold-standard trials have proved that metformin helps treat breast cancer—and her recent research suggests it doesn’t.

Metformin’s development was inspired by centuries of use of French lilac, or goat’s rue (Galega officinalis), for diabetes-like symptoms. In 1918, researchers discovered that a compound from the herb lowers blood sugar. Metformin, a chemical relative of that compound, has been a top type 2 diabetes treatment in the United States since it was approved in 1994. It’s cheap—less than a dollar per dose—and readily available, with few side effects. Today, more than 150 million people worldwide take the stuff.

Read full article

Comments

© Wladimir Bulgar via Getty Images

Eli Lilly raises price of Zepbound while trumpeting discount on starter vials

By: Beth Mole
29 August 2024 at 19:59
An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024.

Enlarge / An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024. (credit: Getty | helby Knowles)

Pharmaceutical giant Eli Lilly earned praise this week with an announcement that it is now selling starter dosages of its popular weight-loss drug tirzepatide (Zepbound) at a price significantly lower than before. But the cheers were short-lived as critics quickly noticed that Lilly also quietly raised the price on current versions of the drug—a move that was notably missing from the company's press release this week.

In the past, Lilly sold Zepbound only in injectable pens with a list price of $1,060 for a month's supply. Several dosages are available—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg—and patients progressively increase their dosage until they reach a maintenance dosage. The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg. The higher the dose, the more the weight loss. For instance, people using the 15 mg doses lost an average of 21 percent of their weight over 17 months in a clinical trial, while those on 5 mg doses only lost an average of 15 percent of their weight.

On Tuesday, Lilly announced that it will now sell Zepbound in vials, too. And a month's supply of vials with the 2.5 mg doses will cost $399, while a month's supply of 5 mg doses is priced at $549—a welcome drop from the $1,060 price tag. These prices are for a self-pay option, meaning that patients with a valid, on-label prescription can buy them directly from Lilly if they have no insurance or have insurance that does not cover the drug.

Read 7 remaining paragraphs | Comments

Buying shady weight loss drugs online is a bad idea, in case you were wondering

By: Beth Mole
2 August 2024 at 21:52
Buying shady weight loss drugs online is a bad idea, in case you were wondering

Enlarge (credit: https://www.uschemlabs.com/product/semaglutide-2mg-5-vials/)

Buying counterfeit weight loss drugs from illegal online pharmacies that don't require prescriptions is, in fact, a very bad idea, according to a study published Friday in JAMA Network Open.

The counterfeit drugs are sold as equivalents to the blockbuster semaglutide drugs, Ozempic and Wegovy, which are prescription only. When researchers got their hands on three illegal versions, they found that the counterfeit drugs had low-purity semaglutide, had dosages that exceeded the labeled amount, and one had signs of bacterial contamination.

The three substandard drugs tested came from three different illegal online pharmacies, which sold them as generic semaglutide drugs for weight loss, appetite suppression, diabetes, and cardiovascular health. However, the researchers, led by scientists at the University of California, San Diego, and the University of Pécs in Hungary, had initially tried purchasing counterfeit drugs from six such sellers.

Read 4 remaining paragraphs | Comments

New weight-loss and diabetes drugs linked to lower risk of 10 cancers

By: Beth Mole
9 July 2024 at 15:50
Ozempic is a GLP-1 drug for adults with type 2 diabetes.

Enlarge / Ozempic is a GLP-1 drug for adults with type 2 diabetes. (credit: Getty | Steve Christo)

For patients with Type 2 diabetes, taking one of the new GLP-1 drugs, such as Ozempic, is associated with lower risks of developing 10 out of 13 obesity-associated cancers as compared with taking insulin, according to a recent study published in JAMA Network Open.

The study was retrospective, capturing data from over 1.6 million patients with Type 2 diabetes but no history of obesity-associated cancers prior to the study period. Using electronic health records, researchers had follow-up data for up to 15 years after the patients started taking either a GLP-1 drug, insulin, or metformin between 2008 and 2015.

This type of study can't prove that the GLP-1 drugs caused the lower associated risks, but the results fit with some earlier findings. That includes results from one trial that found a 32 percent overall lower risk of obesity-associated cancers following bariatric surgery for weight loss.

Read 6 remaining paragraphs | Comments

Radioactive drugs strike cancer with precision

21 June 2024 at 10:30
Pharma interest and investment in radiotherapy drugs is heating up.

Enlarge / Pharma interest and investment in radiotherapy drugs is heating up. (credit: Knowable Magazine)

On a Wednesday morning in late January 1896 at a small light bulb factory in Chicago, a middle-aged woman named Rose Lee found herself at the heart of a groundbreaking medical endeavor. With an X-ray tube positioned above the tumor in her left breast, Lee was treated with a torrent of high-energy particles that penetrated into the malignant mass.

“And so,” as her treating clinician later wrote, “without the blaring of trumpets or the beating of drums, X-ray therapy was born.”

Radiation therapy has come a long way since those early beginnings. The discovery of radium and other radioactive metals opened the doors to administering higher doses of radiation to target cancers located deeper within the body. The introduction of proton therapy later made it possible to precisely guide radiation beams to tumors, thus reducing damage to surrounding healthy tissues—a degree of accuracy that was further refined through improvements in medical physics, computer technologies and state-of-the-art imaging techniques.

Read 43 remaining paragraphs | Comments

Huge telehealth fraud indictment may wreak havoc for Adderall users, CDC warns

By: Beth Mole
14 June 2024 at 16:59
Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc, is shown in a Cambridge, Massachusetts pharmacy Thursday, January 19, 2006.

Enlarge / Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc, is shown in a Cambridge, Massachusetts pharmacy Thursday, January 19, 2006. (credit: Getty | Jb Reed)

The Centers for Disease Control and Prevention on Thursday warned that a federal indictment of an allegedly fraudulent telehealth company may lead to a massive, nationwide disruption in access to ADHD medications—namely Adderall, but also other stimulants—and could possibly increase the risk of injuries and overdoses.

"A disruption involving this large telehealth company could impact as many as 30,000 to 50,000 patients ages 18 years and older across all 50 US states," the CDC wrote in its health alert.

The CDC warning came on the heels of an announcement from the Justice Department Thursday that federal agents had arrested two people in connection with an alleged scheme to illegally distribute Adderall and other stimulants through a subscription-based online telehealth company called Done Global.  The company's CEO and founder, Ruthia He, was arrested in Los Angeles, and its clinical president, David Brody, was arrested in San Rafael, California.

Read 7 remaining paragraphs | Comments

❌
❌