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“BlueFusion” Male Performance Enhancing Supplement Recalled

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A male sexual performance enhancement supplement, sold over the counter across the U.S., has been recalled for being tainted with unapproved drug ingredients.

The supplement is called BLUEFUSION, and it is manufactured by Ata International Inc. The company is recalling certain lots of the male supplement after findings that the product was tainted with male erectile dysfunction drugs and other substances that were not declared on the packaging.

Specifically, the pills tested showed the presence of the drugs sildenafil and tadalafil, both of which are drugs approved by the US Food and Drug Administration for the treatment of male erectile dysfunction. These two drugs are classified as phosphodiesterase, or PDE-5, inhibitors. The BlueFusion pills also contained the presence of desmethyl carbodenafil and dithiodesmethyl carbodenafil, two substances that are also PDE-5 inhibitors used to treat erectile dysfunction, and therefore carry the same clinical risks as the other ingredients.

The FDA enforced the recall because these drugs were not declared active ingredients on the packaging and labeling of the product. This absence of labeling and information to the consumer renders the entire supplement product unapproved by the FDA, because the agency cannot attest to its effectiveness or overall safety. Therefore, the product is now under recall.

In support of the recall, the FDA warned that it could be dangerous to consumers to ingest a product with undeclared PDE-5 inhibitors. When combined with some prescription drugs, these supplements could be deadly. Experts say that the active ingredients in these drugs could have an unintended interaction with nitrates in other prescription drugs, resulting in a sharp reduction in blood pressure to extremely low, life-threatening levels.

Consumers particularly at risk are those men with high blood pressure, high cholesterol, diabetes or heart disease. Consumers with these issues often already take prescription drugs with nitrates—and therefore at risk for the deadly combination of chemicals.

The FDA’s recall notes that these BlueFusion capsules were sold over the counter in single packages of one dose. The product is promoted as a “safe” and “effective” way for men to enhance their sexual performance and erectile function, without having to take expensive prescription drugs. The packaging instructs consumers to take one pill every three days, and even claims that in addition to the sexual benefits the product can boost energy and overall performance.

But all of those promises mean nothing if the product could be deadly. Therefore, the FDA has pushed this recall of all BlueFusion products until the product’s labeling of ingredients is corrected to comply with FDA regulations.

In the meantime, the agency is urging consumers to call their doctor if they have experienced any problems, particularly related to blood pressure, while taking the BlueFusion product. Likewise, Ata International Inc. is notifying known consumers about the issue, and the manufacturer is accepting returns of all products. Both the FDA and the company are urging distributors and sellers of the BlueFusion supplement to cease its distribution and return all product to the manufacturer.

If you are taking BlueFusion and have experienced any adverse issues or health problems, the FDA asks you to report to the their MedWatch program.

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eBay to Remove Reclined Sleepers from Website

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Consumer Reports asks retailers to stop selling inclined sleepers, citing them as dangerous for infants. This request is for online marketplaces as well, and eBay is complying.

eBay will be banning all inclined infant sleepers from the website, not just those that have recall notices attached to them. This action is in response to a letter sent from Consumer Reports to 15 businesses in the retail industry, including eBay.

Dangerous for Babies

Inclined sleepers for infants angle babies between 10 and 30 degrees, which can be dangerous for them when they fall asleep. Consumer Reports has deemed the entire category or infant reclined sleepers as unsafe because of the overall design. Products in this category have been linked to 73 infant fatalities.

These products are dangerous because they put the babies at an incline for sleeping. The infant’s head can lean forward, putting their chin down on their chest, which can compress the airway and allow them to suffocate. Other issues with these products include soft bedding and having a rounded surface which isn’t in following of the recommendations from the American Academy of Pediatrics (AAP).

eBay has already started enforcing the restrictions and banning products, such as the Hiccapop DayDreamer and Evenflo Pillo Portable Napper. The Fisher-Price Rock ‘n Play Sleeper is one of the best known and was recalled earlier in the year. In fact, over five million products in this category have been recalled. Several brands are still available to purchase even though experts have warned against using them.

Multiple organizations have advised parents, daycare centers and others not to use any infant inclined sleeper, including the AAP and Consumer Federation of America.

The companies contacted in the letter include:

  • Amazon
  • Bed Bath and Beyond
  • Albee Baby
  • Craigslist
  • Buy Buy Baby
  • Facebook
  • Macy’s
  • Kohl’s
  • Target
  • Walmart
  • Magic Beans
  • You Are My Everything

Both eBay and You Are My Everything have agreed to remove the products from sale. Other companies have not replied to the letter. One of the concerns with these products is they are marketed as safe for resting or napping, but it only takes a few minutes for a baby to suffocate when they fall asleep. Experts say it’s wrong to promote them as safe for any amount of sleep. Babies have suffocated in infant reclined sleepers in less than 15 minutes, according to incident reports.

Along with the risk of suffocation, another danger is with the baby being able to roll over. They roll from their back to their stomach if they are left unrestrained, which is another position which increases the risk of suffocation. They may turn into the side of the device and smother.

The AAP recommends putting babies to bed on a firm mattress with no other bedding. They should be placed on their backs with nothing else in the bed. This is the only position which is approved by the AAP and for doctors until the baby is able to turn over by themselves.

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New Tests for Johnson & Johnson Baby Powder Show No Asbestos

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According to Johnson & Johnson, new tests on Johnson’s Baby Powder show that the product is free of asbestos. Trace amounts had been found previously, as reported by the US Food and Drug Administration (FDA).

Testing for Asbestos

A test conducted by the FDA earlier had shown indications of asbestos being present in the powder. In response, the manufacturer recalled a single lot of the baby powder back in October. Since then, Johnson & Johnson has conducted 155 tests using two third-party labs and four testing methods. The samples were from the same bottle used in the FDA tests.

The manufacturer had already responded to the FDA findings by conducting a small test in October which showed no asbestos findings. However, the DFA stood by its results. Officials did say that the difference in tests could be the result of contaminants not being uniform in the product. They also admitted there is no standardized testing to detect asbestos in talc.

The tests that were done by the third-party labs showed no asbestos in the bottle or in any samples of the rest of the lot from which the bottle came. The manufacturer suggested that the FDA results were from contamination or a lab error.

About 33,000 bottles of the product were recalled in the US in October after the FDA results were noted. This was a voluntary recall by Johnson & Johnson and the first time for such a recall. However, it’s not the first time the company has faced accusations that the products cause health issues, including cancer.

Mesothelioma

Asbestos is a known carcinogen, which means it’s likely to cause cancer. In this case, it is mesothelioma, which is a deadly type of cancer that acts fast and is aggressive.

Mesothelioma results from the asbestos fibers getting into the lungs. Over time, continued exposure to asbestos causes the fibers to build up in the lungs. Mesothelioma is a cancer of the lining around the lungs or abdomen as well as other organs.

This is a rare type of cancer that has fewer than 20,000 new cases diagnosed each year. Treatments are available, but they only manage the condition rather than curing it. A person can live for several years with mesothelioma while some have had much longer lifespans after the diagnosis.

Common symptoms of mesothelioma include coughing and pain in the chest. The person may be short of breath and often loses weight. Several options for treatment exist, but the cancer metastasizes quickly. Chemotherapy may be an option as well as radiation. Surgery and other medical procedures may be recommended, but they only help with the condition rather than removing the cancer.

When mesothelioma is caused by exposure to asbestos, it happens over a longer period. Products that contain the material can release it into the environment where the person will inhale it. Slowly, enough of the asbestos will accumulate in the lungs to cause a problem. Because of it being a carcinogen, asbestos is banned from products in the US.

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Vapers May Pay Higher Life Insurance Premiums

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Reinsurers around the world are reevaluating insurance premiums and risk for those who vape. Vapers may end up paying more for insurance than smokers or even be excluded completely from some policies.

Current totals for vaping deaths stand at 47 for one mysterious lung illness that has been connected to vaping. Other health concerns have continued to grow even though some studies show that vaporizers and e-cigarettes help smokers to stop using traditional cigarettes.

Warnings to Insurers

Reinsurers are the companies that insure the insurance providers. They use their vast research tools to help insurers determine risk. While they don’t provide recommendations for pricing or require specific policies, they do give general advice on risk. They can also charge higher premiums or even fail to provide reinsurance if their advice isn’t followed.

In the past, vapers were treated like smokers when it came to insurance. Smokers already pay up to twice as much as nonsmokers for life insurance because of the higher risk for lung cancer and other health problems. Three reinsurers have updated their recommendations on vaping recently with others still considering their guidelines.

The warnings from the reinsurers includes vaping products that contain THC, which is an active ingredient in marijuana. They also focus on younger vapers, particularly insuring those who are under the age of 25 due to the recent illnesses and deaths from the vaping illness. Many of those who have had the illness have been under that age and even still in their teens.

Many insurers are treating vapers the same as smokers while refusing to insure those who are vaping products which may be likely to cause cancer. Supporters of vaping believe this step is harsh because it’s already difficult for people who smoke to get insurance.

Most insurers have already put vapers with smokers when it comes to pricing and risk. The few that didn’t in the past are beginning to change their stance now. Reinsurers are continuing to monitor the information available about vaping and health concerns.

Damage from Vaping

It’s still too early to tell the long-term damage from vaping. If more illnesses from vaping become apparent, it is expected that insurers will respond accordingly. The US Centers for Disease Control and Prevention have recommended that people stop vaping, especially with products that contain THC or vitamin E. Experts suggest that people give up vaping completely until it’s determined what ingredient is causing the epidemic that overtook the nation during the summer.

This is another hit for vaping manufacturers who have already lost customers and support due to the negative publicity and information being presented. They continue to claim that vaping is safer than smoking, but recent deaths have placed a high concern about this idea out to the public. In fact, JUUL was one manufacturer that the FDA gave a warning to for promoting their products as a safer alternative. That claim cannot be made unless specific data is provided to support it, which JUUL did not have. The manufacturer has stopped all marketing in the US but still continues to promote products in other countries.

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