WHO joins Europe, Merck in recommending against ivermectin for COVID-19

ZURICH -- The World Health Organization (WHO) on Wednesday recommended against using generic anti-parasite drug ivermectin in patients with COVID-19 except for clinical trials, because of a lack of data demonstrating its benefits.

The recommendation follows the European Medicines Agency's warning last week against the drug. The U.S. Food and Drug Administration (FDA) has also recommended it not be used for COVID-19.

Officials in the Bolivian city of Trinidad launched a campaign in May last year to give out free doses of ivermectin to combat the coronavirus, although the South American country's health ministry noted the lack of evidence for it as a treatment.

Ivermectin tablets have been approved for treating some worm infestations and for veterinary use in animals for parasites. Merck, an ivermectin manufacturer, has also said its analysis did not support the drug's safety and efficacy for COVID-19.

"This applies to patients with COVID-19 of any disease severity," Janet Diaz, a top WHO official for clinical care response, told reporters of the WHO recommendation, saying it was "based on very low certainty of evidence" that ivermectin helps.

The WHO's review was based on a survey of 16 trials of ivermectin involving 2,400 people, including those comparing it with hydroxychloroquine, an older malaria medicine that has been discredited as a COVID-19 treatment. There were very few placebo-controlled studies of ivermectin.

"We certainly need more data in order to make informed decisions," said Bram Rochwerg, an associate professor at Canada's McMaster University and a co-chair of the WHO panel that reviewed ivermectin.

He said the data available was sparse and likely based on chance, though he said "high quality, trustworthy trials" were still merited.

"We did see an increase in adverse effects in patients that were randomized to ivermectin," he said, citing gastrointestinal upsets and headaches.

Worldwide, he said, there are 66 trials of ivermectin registered, with 60,000 participants, so more data on its impact on the pandemic could be coming.

"We are fighting this overuse of unproven therapies -- especially some of these repurposed drugs -- in various parts of world without evidence of efficacy," Diaz said. "There can be more harm than any good." 

-reuters

Vape company Juul warned over claims e-cigarette safer than smoking

WASHINGTON — Federal health authorities on Monday blasted vaping company Juul for illegally pitching its electronic cigarettes as a safer alternative to smoking and ordered the company to stop making unproven claims for its products.

The Food and Drug Administration also upped its scrutiny of a number of key aspects of Juul’s business, telling the company to turn over documents about its marketing, educational programs and nicotine formula.

The FDA action increases the pressure on the nation’s best-selling vaping company, which has been besieged by scrutiny from state and federal officials since a recent surge in underage vaping. Federal law bans sales to those under 18. The FDA has been investigating Juul for months but had not previously taken action against the company.

A Juul spokesman said the company “will fully cooperate” with the FDA.

In a sternly worded warning letter, the agency flagged various claims made by Juul representatives, including that its products are “much safer than cigarettes.” Currently no vaping product has been federally reviewed to be less harmful than traditional tobacco products, and that won’t happen for a while.

In the past year, Juul has tried to position its e-cigarettes as a tool to help adult smokers stop smoking, using the tagline “Make the Switch.” In a separate letter to the company’s CEO, the FDA said it is “concerned” that the advertising campaign suggests “that using Juul products poses less risk or is less harmful than cigarettes.”


“JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth,” said FDA acting commissioner Ned Sharpless, in a statement.

The agency’s warning letter highlights an incident recounted by two New York high school students during a congressional hearing in July. The students told House lawmakers that a representative from Juul was invited to address the school as part of an assembly on mental health and addiction issues. During the presentation, the students said the representative told them the company’s product was “totally safe.” The representative also showed students a Juul device and claimed the FDA “was about to come out and say it was 99 percent safer than cigarettes.”

Juul says it discontinued its school programs — which were intended to discourage underage use — last September. Juul and similar small, discrete e-cigarettes have become a scourge in U.S. schools nationwide.

FDA warning letters are not legally binding, but regulators can take companies to court if they don’t comply with their requests. Juul has 15 business days to respond with a plan for fixing the problems.

E-cigarettes have been on the U.S. market for more than a decade, but the FDA didn’t gain the authority to regulate them until 2016. E-cigarette makers have until next May to submit their products to the FDA for health reviews.


Most experts, though, agree the aerosol from e-cigarettes is less harmful than cigarette smoke since it doesn’t contain most of the cancer-causing byproducts of burning tobacco. E-cigarettes generally heat liquid containing nicotine. But there is virtually no research on the long-term effects of vaping.

The recent outbreak of lung illnesses mostly involves people who said they vaped marijuana.

In the letter to Juul CEO Kevin Burns, FDA regulators said they were “troubled” by a number of other points raised at the congressional hearing. The letter cites testimony that Juul’s advertising “saturated social media channels frequented by underage teens,” and “used influencers and discount coupons to attract new customers.”

Last year, Juul closed down its social media sites. And under pressure, it also voluntarily removed its fruit and dessert flavors from retail stores. The FDA has proposed regulations on e-cigarettes that would restrict their sales in most stores, though they have not been finalized.

In a tweet Monday, first lady Melania Trump said she was concerned about the “growing epidemic of e-cigarette use in our children.”

FDA regulators also asked Juul to turn over detailed information about its potent nicotine formula. In the last year, researchers have published several papers analyzing Juul’s use of “nicotine salts,” a formulation which allows users to inhale higher levels of nicotine with reduced throat harshness.

Regulators asked the company to explain why it uses nicotine salts and how this affects potential addiction.

The letter also criticizes the company for apparently turning over more documents to congressional investigators than to the agency “despite previous document requests from FDA.” /jpv

source: technology.inquirer.net

US senator: Exploding e-cigarette recalls need to be considered

NEW YORK — US Sen. Charles Schumer is increasing the heat on the federal government to consider recalling e-cigarette batteries and devices that explode and catch fire, injuring users.

Schumer, a New York Democrat, has called e-cigarettes “ticking time bombs” and said they continue to cause injuries including severe burns.

E-cigarette user Katrina Williams, a New York freight manager, said she wanted a safer alternative to smoking regular tobacco cigarettes and thought e-cigarettes were the answer – until one exploded in her pocket in April as she drove home from a beauty salon.

“It was like a firecracker,” she said, as it seared third-degree burns in her leg, blasted through her charred pants and stuck in the dashboard.

As the use of e-cigarettes has increased over the past year, similar painful accidents have been recorded with greater frequency, with faulty lithium-ion batteries seen as the likely culprits. The same types of batteries are used safely in many consumer electronics, but they’ve been behind fires in hover boards and smartphones.

Schumer said he wants the US Consumer Product Safety Commission and the US Food and Drug Administration to figure out why so many devices, many from China, are exploding. He said the recent injuries are proof federal action is needed.

Schumer, who planned to hold a press conference on Sunday to address the issue, cited a recent Associated Press story saying the FDA identified about 66 explosions in 2015 and early 2016 after recording 92 explosions from 2009 to September 2015.

The AP story said the numbers kept by the FDA may be an undercount. Just one hospital, the UW Medicine Regional Burn Center at Harborview Medical Center in Seattle, said it has seen more than 20 patients with e-cigarette burns since it started tracking them informally in October 2015.

The industry maintains e-cigarettes are safe when used properly. The Tobacco Vapor Electronic Cigarette Association encourages proper recharging of the batteries as a way to prevent possible injuries.

The FDA has said it’s reviewing e-cigarettes and will evaluate their batteries, including “amperage, voltage, wattage, battery type” and other issues.

source: newsinfo.inquirer.net

Fixing media noche? Check food labels

If you’re doing some last-minute grocery shopping for New Year’s Eve, it pays to check food labels meticulously, ensuring that the packaging and seal of the food items are intact and they were are stored in a clean environment.

The Food and Drug Administration (FDA) on Wednesday offered these tips to merrymakers to avoid stomach troubles and other health problems caused by feasting on compromised or adulterated food products.

“This Christmas and New Year, there is high demand for food products as Filipino families traditionally celebrate through preparation of meals for festivities,” said FDA officer in charge Director General Maria Lourdes Santiago in an advisory.

Basic consumer tips
“Unwary consumers might succumb to unscrupulous food business operators selling compromised, improperly handled and stored, misbranded and adulterated food products,” she warned.

Santiago said the FDA had prepared basic consumer tips on buying food products for the holidays to avoid eating unsafe food.

Earlier, the Department of Health (DOH) said festivities during the holiday season could spawn food poisoning incidents if the food is not handled properly.

The Southeast Asian region, including the Philippines, has the second highest incidence of food-borne illnesses next to Africa, according to the World Health Organization (WHO). It registers 150 million cases and 175,000 deaths annually, it said.

Most of these cases are caused by non-typhoidal salmonella, E. coli and pork tapeworm, said the WHO.

Storage condition

In checking food labels, one must pay attention to the following information: brand and product name, net content or weight, list of ingredients, name of manufacturer/repacker/distributor/

importer, expiry date, lot identification code and nutrition information.

One must also check the food item’s storage condition, especially for those needing storage beyond the normal room temperature, food allergen information (such as nuts, milk and crustaceans) and direction for use.

Tampered label details, like scratched out information and a new expiry date pasted over the original one, should be considered red flags, the FDA warned.

To ensure that food items are still safe for eating, the FDA said soft packaging materials like plastic, foil and aluminum wrap must not have tears or perforations.  Metal bottle caps must be rust-free  while glass bottles should be crack-free.

It advised consumers not to buy canned goods that are dented, bulging and rusting.

“Food products must at all times be sold under optimal hygienic conditions [such that] the probability of cross-contamination from biological, chemical and microbial hazards must be reduced, minimized and eliminated,” the FDA said.



Cross-contamination

Frozen and refrigerated products must be kept frozen or stored in a refrigerator while perishable products should be kept away from non-perishables to prevent cross-contamination, it noted.

Consumers were also advised against buying food sold in a dirty environment or in areas infested by rodents, insects and other pests.

“Consumers are advised to be more vigilant and conscious in buying food products in the market to avoid health and safety issues,” the FDA said.

source: lifestyle.inquirer.net

US approves first drug for rare erection disorder

WASHINGTON — The Food and Drug Administration has approved the first drug to treat an unusual condition that causes painful, curved erections in men.

The agency says it approved the biotech drug Xiaflex to treat Peyronie’s disease, which causes an abnormal bend in the penis during erection. The disease is caused by scar tissue and can lead to pain and other difficulties during sex.

The FDA says the injectable drug is the first non-surgical treatment for the disease.

Drugmaker Auxilium Pharmaceuticals estimates 5 percent of U.S. men are affected.

The FDA said it is limiting distribution of the drug to certified physicians and health care centers due to serious potential side effects, including injury of the penis. Health care professionals must enroll and complete a training program before prescribing the drug.

source: business.inquirer.net

US approves more powerful, pure hydrocodone drug

WASHINGTON  — The U.S. Food and Drug Administration has approved a stronger, single-ingredient version of the painkiller hydrocodone, the widely-abused prescription medicine for chronic pain.

The agency said Friday it approved the pill Zohydro for patients with pain that requires “daily, around-the-clock, long-term treatment” that cannot be addressed with other drugs.

Hydrocodone is currently sold in combination pills like Vicodin to treat pain from injuries, surgery, arthritis, migraines and other ailments. The new drug from Zogenix is the first pure, non-combination form of the drug approved in the U.S.

The approval came as a surprise since the agency’s own panel of outside advisers gave the drug an overwhelmingly negative review last year. The agency’s panel of pain specialists voted 11-2, with one abstention, against approving the drug last December, questioning the need for a new form of one of most widely-abused prescription painkillers in U.S.

Zohydro’s approval was quickly criticized by patient safety advocates who had urged the FDA to reject the drug at a public meeting last year.

“We’re just going to kill more kids and then the FDA is going to come back and say, ‘oh, we made a mistake,’” said Avi Israel. Israel’s son Michael committed suicide in 2011 while struggling with painkiller addiction. Israel is the founder of a group called, Save the Michaels of the World, which aims to combat painkiller abuse in young people.

In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures. Hydrocodone pills also consistently rank among most-abused medicines in the U.S., according to the DEA.

The drug belongs to a family of medicines known as opiates or opioids because they are chemically similar to opium. They include morphine, heroin, oxycodone, codeine and methadone.

Friday’s news was also blasted by lawmakers in Congress who have been trying to rein in prescription drug abuse in their home states.

Rep. Bill Keating, a Democrat, said the FDA should have required the drug to contain anti-abuse design features that would make it harder for users to crush the pills and snort or inject them.

“FDA not only approves this dangerous drug, but does so without requiring any abuse-deterrent features. This is outrageous,” Keating said in a statement. “Abuse-deterrent technologies should not be the anomaly, they must be the norm.”

In recent years, Purdue Pharma, Pfizer Inc., Endo Health Solutions Inc. and other drugmakers have developed tamper-resistant versions of popular opioid drugs.

The timing of the FDA announcement also drew criticism from safety advocates and lawmakers. Only one day earlier the FDA said it would support stronger restrictions on combination drugs containing hydrocodone, including Vicodin and dozens of other generic formulations.

The drugs currently available mix hydrocodone with non-addictive pain relievers like aspirin and acetaminophen. For decades these drugs have been subject to less rigorous prescribing limits than other prescription painkillers like oxycodone.

Late Thursday, the FDA said it would recommend moving hydrocodone drugs from the schedule III class to the schedule II class of medications, a move that will limit the number of refills patients can receive and how many health professionals can prescribe the drugs.

The Drug Enforcement Administration had first asked the agency to take that step a decade ago, and lawmakers and safety advocates had increased their pressure on the agency in recent years.

Shares of Zogenix, Inc. jumped in trading Friday, climbing 80 cents, or 36 percent, to $3.04. Earlier shares set a 52-week high of $3.45.

source: business.inquirer.net

Weight loss pills and diet pills are available in in many shapes and sizes

Fat reduction pills and diet pills are available in in a variety of shapes and sizes. Diet pills and fat reduction pills can be found in a variety of shapes and sizes. Weight loss pills are specifically designed to help decrease and control your body weight. Weight loss pills are categorised as ‘dietary supplements.’ This means that they do not have to be approved by the FDA. Makers of drug products do have to be FDA approved which involves proving that the product is effective and safe. The only requirement for a dietary supplement is that the labelling has to be truthful and not misleading.

Weight reduction pills are occasionally referred to as anti obesity drugs. Some types of weight reduction pills require a prescription but there are a huge number that can be purchased freely from a number of different outlets. For many years a large number of weight reduction pills contained Ephedra which has been used to treat a wide variety of health problems in China for in excess of five thousand years. In 2004 however the FDA finally banned the marketing of supplements containing Ephedra in the USA after a number of deaths that were linked to the drug. There are still a number of products available that are designed to closely mimic the properties of Ephedra.

A large number of the products today contain mainly herbal ingredients which are free of disagreeable or dangerous side effects.

There are two main categories of weight reduction pills. They are fat burners and hunger suppressants.

Fat burners increase your body temperature a little which raises your metabolic rate and results in some of your excess fat being burned off. Doctors will on occasion prescribe fat burners to patients suffering from obesity who are unable to exercise. The top fat burners will also assist you in conditioning and regulating your metabolic rate so as that you are able to maintain your weight.

Appetite suppressants help you to manage your eating habits. These types of pills and supplements are referred to as being ‘anorectic’ which comes from a Greek word that translates as 'having no appetite'. Hunger suppressants are designed to reduce your food consumption but still feel full. Eating smaller amounts clearly reduces your calorie intake thereby promoting weight reduction.

Some of the products that you can buy act both as hunger suppressants and fat burners. The manufacturers of Capsiplex ,which is acknowledged as being one of the top fat burners, state that you can burn off an extra 278 calories a day purely by taking Capsiplex pills.

If you prefer to take hunger reducers like Uniquehoodia it is possible to reduce your intake of calories by as much as 2000 calories per day without feeling hungry.

Although it is possible to cut your weight by just taking weight loss pills and supplements it is recommended to lose weight with pills in conjunction with a properly formulated diet and a realistic exercise programme. This will increase the rate of weight loss and also assist you in maintaining your body weight once you have achieved your target weight. You should always set yourself sensible weight reduction targets and do not try to lose too much weight too rapidly. It is advisable to lose no more than 3-5 lbs a week for the majority of people.

There is a huge choice of weight loss products available on the market. The most widely used weight loss pills are fat burners and hunger suppressants.

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