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Juul Halts Sale of Fruit, Dessert Vape Flavors

By Dennis Thompson
HealthDay Reporter

THURSDAY, Oct. 17, 2019 (HealthDay News) — Juul, which makes the top-selling brand of electronic-cigarettes in the United States, said Thursday it will no longer sell fruit or dessert flavors of its products.

The company’s decision comes as it faces widespread criticism that its flavored nicotine products are hooking a generation of teenagers on nicotine and vaping, the Associated Press reported Thursday.

The company faces multiple investigations by Congress, the U.S. Food and Drug Administration and several state attorneys general. Juul is also being sued by adults and underage vapers who allege they became addicted to nicotine by using Juul’s products, the wire service said.

The Trump administration has also proposed banning nearly all e-cigarette flavors.

The flavors dropped by Juul will be mango, creme, fruit and cucumber, which account for 10% of its sales. The company will continue to sell its most popular flavors: mint and menthol, the AP reported.

Juul’s decision to continue selling mint and menthol shows “it isn’t serious about preventing youth use,” said Matthew Myers, from the Campaign for Tobacco-Free Kids.

“Juul knows that 64% of high school e-cigarette users now use mint or menthol flavors, and this number is growing all the time,” Myers said in a statement.

His group and others say the Trump administration should ban all vaping flavors except tobacco, the AP added.

Meanwhile, the U.S. Centers for Disease Control and Prevention reported Thursday that the number of severe lung illnesses continues to climb: There are now 1,479 cases reported in 49 states. Seventy-eight percent of those cases involved products that contained THC, the psychoactive ingredient in marijuana. Seventy percent of these patients were male, and 79 percent were under the age of 35.

The death toll also went up, hitting 33 deaths in 24 states. The median age of patients who have died is 44, the CDC added.

Products containing the marijuana chemical THC seem to be a main driver behind the illnesses.

While THC is a main suspect in the CDC’s investigation, a recent study suggested other chemicals might play a role.

Continued

Researchers at the Mayo Clinic Arizona conducted an examination of 17 cases involving vaping-linked lung injury — including lung biopsies. All of the patients examined had severe forms of the illness, and two had died.

“Based on what we have seen in our study, we suspect that most cases involve chemical contaminants, toxic byproducts or other noxious agents within vape liquids,” said lead researcher Dr. Brandon Larsen. He’s a surgical pathologist at the Mayo Clinic Arizona, in Scottsdale.

Those findings were published Oct. 2 in the New England Journal of Medicine.

While THC does seem to figure prominently in many cases, Dr. Anne Schuchat, principal deputy director of the CDC, has stressed that nicotine-containing vaping products without THC cannot be ruled out as a potential cause of harm. Because of that, the CDC recommendation for everyone to stop vaping stands.

What is clear is that the illnesses that are affecting vapers can be sudden and severe. Symptoms include cough, shortness of breath and chest pains. Some patients have had so much trouble breathing that they wind up on oxygen, and in extreme cases are placed on a mechanical ventilator.

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Sources

SOURCES: U.S. Centers for Disease Control and Prevention, news release,  Oct. 17, 2019;  Oct. 3, 2019 media briefing with: Anne Schuchat, M.D., principal deputy director, U.S. Centers for Disease Control and Prevention;Associated Press; Oct. 17, 2019, statement, Campaign for Tobacco-Free Kids

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Juul Halts Funding For Vaping Ballot Initiative

Oct. 1, 2019 — On Monday, San Francisco-based Juul Labs Inc. said it will no longer fund an effort to quash an anti-vaping law in the city, effectively ending the campaign.

Juul, the largest maker of e-cigarettes, is ending support for the measure after giving nearly $ 19 million, according to the Associated Press.

Juul’s decision follows closely on major changes at the company, including replacing its CEO.

The proposition, however, will still be on the ballot in November.

The law, called proposition C would permit the sale of vaping products to adults. If it passes, it would override a law passed in June banning the sale of any e-cigarette that has not been reviewed by the U.S. Food and Drug Administration.

“This could very well be yet another of a series of lies and exaggerations from Juul and Big Tobacco,” Larry Tramutola, who directs the No on Prop C campaign said in a statement.

“Until they return the $ 7 million unspent dollars that is in their political account, until they suspend their mail, their advertising, their paid phone calls and lay off their consultants, we do not believe them,” he said.

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Maker Halts Distribution of Generic Zantac Due to Possible Carcinogen

By Robert Preidt
HealthDay Reporter

THURSDAY, Sept. 19, 2019 (HealthDay News) — Novartis, the maker of a generic form of the popular heartburn drug Zantac, said Wednesday it will cease distribution of the medicine after investigations suggested that generic and branded versions contain a known carcinogen.

A distribution halt is not the same as a full recall, and it means that generic Zantac (ranitidine) remaining on store shelves can still be sold, CBS News reported.

The move stems from an announcement made last Friday by the U.S. Food and Drug Administration. In a statement, the agency said that a substance that could cause cancer had been found in some ranitidine heartburn and ulcer medicines, including the brand name drug Zantac, and the source of this contamination is being investigated.

Sanofi, the maker of Zantac, said in a statement on Wednesday that “there are currently no plans to stop distributing or manufacturing Zantac or other ranitidine products outside of Canada,” and added that “we are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards.”

While preliminary tests found low levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA) in some ranitidine products, the FDA said last week that this does not mean patients taking the drugs should now stop using them.

NDMA is the same contaminant found in many brands of blood pressure and heart failure medications during the past year, leading to recalls.

Patients who are taking prescription ranitidine who want to stop using it should discuss alternatives with their health care provider, the FDA advised. Those taking over-the-counter (OTC) ranitidine could switch to other OTC heartburn medicines.

Several drugs are approved for the same or similar uses, the FDA noted.

NDMA is an environmental contaminant found in water and foods, including meats, dairy products and vegetables. It is classified as a probable human carcinogen.

“Drug impurities remain a major national concern,” said Dr. David Robbins, associate chief of endoscopy at Lenox Hill Hospital in New York City. “While Zantac may prove safe in the long run, this latest statement adds confusion and concern, so my interim advice to patients is simple: switch to another drug … and of course, confirm with your doctor the need for an antacid.”

Continued

The FDA said it’s evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and that it will post that information when it’s available.

In a statement, Sanofi said that it “takes patient safety seriously, and we are committed to working with the FDA. Zantac OTC [over the counter] has been around for over a decade and meets all the specified safety requirements for use in the OTC market.”

In the meantime, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the FDA is working with international regulators and industry partners to find out where the contamination originated.

“The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients,” she said in a news release. “The FDA will take appropriate measures based on the results of the ongoing investigation.”

Large amounts of NDMA may pose a risk, but the levels of NDMA found in ranitidine in preliminary tests barely exceed amounts found in common foods, according to the FDA.

Ranitidine decreases the amount of acid created by the stomach. OTC ranitidine is approved to prevent and relieve heartburn, and prescription ranitidine is approved for a number of uses, including treatment and prevention of ulcers of the stomach and intestines, and treatment of gastroesophageal reflux disease (GERD).

Similar contamination in heart medicines is also under investigation.

“The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers [ARBs] since last year,” Woodcock said. “In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”

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Sources

SOURCE:CBS News; U.S. Food and Drug Administration, news release, Sept. 13, 2019

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New York Halts Religious Vaccine Exemption

June 14, 2019 — Reacting to an ongoing measles outbreak, New York state has eliminated the religious exemption for not vaccinating children.

Most school systems require proof of vaccination to allow a child to attend class, but by claiming their religion doesn’t allow vaccinations, parents could duck the requirement, the Associated Press reported.

Not everybody was happy about the new law. Parents of hundreds of unvaccinated kids protested in Albany claiming the law violated religious freedom.

“People came to this country to get away from exactly this kind of stuff,” Stan Yung, a Long Island attorney, told the AP.

Those who supported the bill said that religion shouldn’t trump science. In 1905, the U.S. Supreme Court said states can enforce vaccination laws.

When the bill was debated in the Assembly, members reminded their colleagues of the deadly disease prevented by vaccines.

“I’m old enough to have been around when polio was a real threat,” said Assemblywoman Deborah Glick, D-Manhattan. “I believe in science…. Your personal opinions, which may be based on junk science, do not trump the greater good,” the AP reported.

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FDA Halts All Sales of Pelvic Mesh Products Tied to Injuries in Women

TUESDAY, April 16, 2019 — The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products.

The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.

“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”

Simply put, the remaining makers of the mesh devices — Boston Scientific and Coloplast — failed to prove the long-term safety or benefit of their devices, the FDA said in a news release.

The companies will have 10 days to submit plans to withdraw these products from the market, the FDA said. Most pelvic mesh products have already been taken off the market, according to the Associated Press.

The products are the subjects of lawsuits by the states of Washington, California, Kentucky and Mississippi. Those states claim that pelvic mesh maker Johnson & Johnson did not fully disclose safety risks, the AP has reported.

But some doctors who specialize in female pelvic medicine oppose the lawsuits, saying the procedure can work for some women.

Surgical mesh has been used since the 1950s to repair abdominal hernias. Implanting surgical mesh for abdominal repair of POP began in the 1970s. In 2002, the first mesh device for transvaginal repair of POP was approved by the FDA as a moderate-risk device.

About one in eight women will need surgery to repair POP, and a portion of such surgeries have been done transvaginally with the use of surgical mesh.

However, the FDA has issued repeated warnings about the risks associated with using transvaginal mesh for POP repair.

Women who’ve had the procedure should continue with routine check-ups. No additional measures are needed if they are satisfied with their surgery and don’t have complications or symptoms, the FDA said Tuesday.

Those who do have complications or symptoms — such as persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex — should see their health care provider, the agency added.

They should also inform their health care provider if they have surgical mesh, especially if they’re scheduled for another surgery or medical procedure.

Women who were planning to have transvaginal mesh repair of POP should discuss other treatment options with their doctors, the FDA advised.

More information

The National Association for Continence has more on pelvic organ prolapse.

© 2019 HealthDay. All rights reserved.

Posted: April 2019

Drugs.com – Daily MedNews

Doggone it! Stray canine halts practice in Texas

(Reuters) – A stray dog halted first practice for Sunday’s MotoGP race at the Circuit of the Americas on Friday after the animal ran onto the rainsoaked track in front of riders.

The incident, on the same day that a spectator caused alarm by running across the main straight in Formula One practice at the Chinese Grand Prix in Shanghai, brought out the red flags for safety reasons.

The dog was caught and the session, which had already started late due to delays in getting marshals into position, resumed after a 20-minute delay.

“Dog gone. Let’s get back on track,” the Texan circuit’s Twitter feed announced.

Italian Andrea Dovizioso was fastest on a Ducati, ahead of Spain’s double world champion Marc Marquez on a Honda.

(Reporting by Alan Baldwin in London, editing by Tony Jimenez)


Reuters: Oddly Enough

Moscow’s Domodedovo Airport Halts Flights After Power Outage

Galanova said by telephone from Moscow today. Incoming flights are being diverted to Moscows Sheremetyevo airport, state-run Vesti-24 television said. Thousands of passengers have been stranded, the television said, without citing anyone. The power
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