The FDA gives the green light to imports of Chinese cancer drugs with a cure rate of up to 90%.

The FDA gives the green light to imports of Chinese cancer drugs with a cure rate of up to 90%.

A drug that is the “backbone” of chemotherapy will be imported from China into the United States, the Food and Drug Administration (FDA) has announced.

The cisplatin used by one in five cancer patients has been in shortage since February, due to the closure of a major supplier.

This drug, which has a 90% cure rate for testicular cancer, treats many types of diseases affecting the bladder, cervix, ovaries, lungs, breasts, and head and neck.

To shore up dwindling inventories, the FDA has approved a company based outside Beijing to manufacture and supply doses.

The agency also plans to approve a new supplier for another chemotherapy drug, carboplatin, which has been in shortage since late April.

Nearly two dozen chemotherapy drugs are in short supply nationwide due to a nationwide drug shortage, forcing many doctors to opt for alternatives that may be less effective.

The FDA has approved the import of stocks of the chemotherapy drug cisplatin produced near Beijing (stock)

The FDA revealed last week that it approved Qilu Pharmaceuticals to begin supplying cisplatin in the United States.

The doses will be supplied in 50-milligram vials labeled in Chinese and will be distributed by Canadian company Apotex, with deliveries expected to begin within weeks.

Cisplatin is one of the best chemotherapy drugs available, with Johns Hopkins oncologist Dr. Amanda Fader telling CNN that it is “the backbone of chemotherapy.”

In announcing the deal, FDA Commissioner Dr. Robert Califf, said, “We have taken steps to temporarily import certain approved overseas versions of cisplatin products from FDA-registered facilities.

‘[We’ve] used regulatory discretion to provide continued supply of other cisplatin and carboplatin products to help meet patient needs.’

He added: ‘In these situations, we evaluate product quality very carefully and require companies to take certain steps to ensure that products are safe for patients.

“The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs.”

The US cisplatin shortage erupted when Indian supplier Intas Pharmaceuticals, a major producer, was shut down after failing an inspection.

The inspection was called a “textbook example of what not to do when investigators come knocking,” after the FDA shut down the facility saying it found shredded papers and acid-soaked trash cans at the facility.

This quickly triggered a shortage, with most drug makers already running at full capacity unable to cope with the shortfall.

The United States will begin importing doses of the chemotherapy drug cisplatin from China to help ease shortages.  It is administered to patients intravenously

The United States will begin importing doses of the chemotherapy drug cisplatin from China to help ease shortages. It is administered to patients intravenously

It has led regulators in the United States to turn to China for assistance, which is the country’s fourth-largest drug supplier.

There are concerns in some policy circles that China may weaponize these drugs against America to gain concessions.

Rosemary Gibson, senior adviser on health issues at a New York-based think tank, previously said: “Medicines can be weaponized against the United States.

“Supplies can be withheld. Medicines can be made with lethal contaminants or sold without any real medicine in them, rendering them ineffective.’

Dr. Fader said the shortage has forced doctors to start replacing cisplatin with other drugs.

“In many cases, these drug substitutions will be just as effective in terms of treatment response,” he said.

“However, many of these drugs may have worse side effect profiles or different dosing schedules that require two to three times longer dosing times.”

The FDA also resorted to drug imports last year due to shortages of the chemotherapy drug Doxil, which can be used to treat ovarian and breast cancer.

Cisplatin works by interfering with the DNA of cancer cells to trigger their death, helping to eliminate the disease from the body.

It is typically given intravenously by healthcare professionals, and patients can be on treatment for weeks at a time.

#FDA #green #light #imports #Chinese #cancer #drugs #cure #rate

Ozempic and Wegovy: FDA warns of increase in off-brand versions

A pharmacist is seen working.

A pharmacist is seen working.Share on Pinterest
The FDA has issued a warning against compound drugs similar to Ozempic and Wegovy that haven’t been tested for safety or efficacy. Terry Vine/Getty Images
  • The FDA has issued a warning on GLP-1 drugs similar to Ozempic and Wegovy.
  • These drugs differ from FDA-approved Ozempic and Wegovy because they are made by online pharmacies and other uncertified sources.
  • These compound drugs are made by mixing or altering drugs to create a semaglutide-like drug.
  • The health risks of the compound semaglutide are not yet known, but off-label versions of the drug may contain contaminants.
  • The FDA cannot verify the safety or efficacy of compound semaglutide drugs, especially those made with salt, that have not undergone rigorous testing.

The Food and Drug Administration (FDA) has issued a warning against modified glucagon-like peptide-1 (GLP-1) drugs, such as semaglutide, that are being sold.

The United States has experienced a shortage in both Ozempic, used to treat type 2 diabetes, and Wegovy, used to treat obesity, since early May 2023.

As a result, online pharmacies and uncertified sources sell GLP-1 drugs made with different ingredients than those used in approved drugs.

These drugs, called compound drugs due to mixing or altering ingredients to create a drug, are marketed as semaglutide.

Compound drugs aren’t approved by the FDA, and the agency doesn’t test compound drugs for safety or efficacy, the FDA said in his warning.

The FDA issued the warning after the agency received reports of people taking the compound semaglutide.

The compounded drugs may contain unwanted contaminants or have a different potency than FDA-approved drugs, Dr. Kelly Johnson-Arbor, a medical toxicologist and co-medical director of the National Capital Poison Center, told Healthline.

There have been incidents of people becoming very ill and even dying from other types of compound drugs, Johnson-Arbor said.

In some cases, the compound semaglutide drugs consisted of saline forms of semaglutide, including semaglutide sodium and semaglutide acetate, which are different from the FDA-approved versions of semaglutide sold under the brand names Ozempic and Wegovy.

According to the FDA, these salt versions have not been shown to be safe or effective.

It is also not clear what the health risks are.

Essentially, you’d be using an uncontrolled substance, possibly illegally imported into the United States, with no control over what’s in it, Dr. Dan Azagury, an associate professor of surgery at Stanford Healthcare, told Healthline.

The Alliance for Compounded Pharmacy released a statement last week saying the compound semaglutide is technically ineligible to be sold by compounding pharmacies.

Some compounding drugs may be legally prescribed by a licensed health care practitioner and sold by compounding pharmacies as they must meet stringent compounding standards.

For example, people with an allergy to a certain dye can get the drug without it, says Azagury.

But in this situation, the current semaglutide molecule is probably only produced by Novo Nordisk. If they don’t have enough, no one does, Azagury said.

David Lebo, PhD, a professor of pharmaceutical sciences at Temple University’s School of Pharmacy, explained to Healthline that compounding should never be used as a substitute for a commercial product, such as Ozempic, unless there are specific reasons such as adjustments to the dose, route of administration or to make the drug available to special populations.

To avoid buying a compound version of semaglutide, you should only get your prescription through a licensed healthcare professional and pick up your medications from a state-licensed pharmacy or facility registered with the FDA.

The APC has warned consumers to avoid unreliable online retailers.

If your doctor hasn’t written you a prescription for the compound semaglutide and mailed it to a legitimate, identifiable pharmacy, be wary of the seller of that substance, says the APC.

If you are buying your medications online, make sure that the retailer is licensed and regulated and that the medications are made by the drug manufacturer Novo Nordisk.

For tips on evaluating the legitimacy of your online retailer, visit the FDA website BeSafeRx.

Illegitimate versions of semaglutide tend to be cheaper.

When searching for semaglutide online, look for clues such as not for human use or laboratory use only to identify formulations of the drug that are intended for use only as research chemicals and are not approved by the FDA for use in the man, Johnson-Arbor said.

If you think you have taken or purchased compound semaglutide, report the incident to the FDA MedWatch Adverse Event Reporting.

A certified healthcare provider can help you get the drug in a supervised process with the right support, Azagury said.

If you can’t access semaglutide due to a shortage, there are several other drugs in this class, Lebo said.

Patients should have a conversation with their doctor or pharmacist about some of the options, Lebo noted.

The FDA has issued a warning against modified GLP-1 drugs, such as semaglutide, that are being sold.

There was a shortage in both Ozempic and Wegovy since May 2023, and some uncertified resellers are selling a modified version of the drug made with saline forms of semaglutide.

The salt versions haven’t been tested, so it’s unclear how safe and effective they are, and what the health risks are.

Health experts say you should not take fake or compounded semaglutide under any circumstances.

You are working on losing weight to improve your health so as not to endanger it by using these drugs, Azagury said.

#Ozempic #Wegovy #FDA #warns #increase #offbrand #versions

The FDA warns against the compound semaglutide

The FDA warns against the compound semaglutide

The United States Food and Drug Administration (FDA) warns against going to compounding pharmacies for generic versions of semaglutide, the active ingredient in Wegovy and Ozempic.

Compound drugs can mix, combine, or alter ingredients to create drugs that are tailored to the needs of individual patients. Medicines can be compounded when there is a shortage of FDA-approved drugs, as is the case with Wegovy and Ozempic, the FDA said.

But the FDA has raised concerns that patients may experience unexpected side effects with compound semaglutide, which can be made with salt-based forms of semaglutide other than the active ingredient in Wegovy and Ozempic.

Patients should be aware that some products sold as semaglutide may not contain the same active ingredient as FDA-approved semaglutide products and may be saline formulations, the FDA said in a statement. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.

#FDA #warns #compound #semaglutide