In a move that came as somewhat of a surprise given the Food and Drug Administration’s initial feelings on the matter, an advisory panel has recommended the approval of an anti-insomnia drug from Merck.  The panel convened yesterday let the FDA know that the drug known as suvorexant appears to be both effective and safe for patients.  They explained that doses recommended by Merck seemed appropriate and that insomnia sufferers appear to have been able to get sleep.  What’s interesting is that this runs somewhat counter to the FDA’s own findings.  Reports from earlier in the week suggested that the FDA was concerned about issues with extensive drowsiness after the effects of the drug were supposed to have worn off.  Also troubling the FDA were reports about the onset of suicidal thoughts.

Click here for more about the panel’s thoughts.

If your worksite uses a pallet truck, then you might take a look at some of the safety tips included in a new report out of the United Kingdom.  Even slight mishandling of such a device can lead to a potential tragedy, and it’s essential that you not make a mistake with long-lasting consequences.  First, always follow the manufacturer’s usage recommendations, especially in regards to the weight limit.  Overloading a pallet can cause a potentially injurious malfunction.  Caution also needs to be taken while moving on a slope.  You should move uphill when possible so that you can maintain control of the load.  If on a flat area, though, pulling is acceptable.  Limit your speed, especially if people are around and your particular unit does not contain a hand brake.

For more tips, click here.

The Food and Drug Administration is currently in the midst of reviewing a drug from Merck that would be used for the treatment of insomnia.  Known as suvorexant, the drug has been shown in clinical trials to assist persons in falling asleep and then staying asleep once under, but those same trials have also illuminated a startling trend.  When the dosage is upped to 20 or 40 milligrams, drowsiness became a possibility the day after administration of the drug, and driving ability was also compromised.  Four females involved in the driving test had to actually cease driving in the middle of the test because they were so tired.  The FDA is also troubled by eight instances of patients experiencing thoughts of suicide.  An expert panel will advise the FDA tomorrow and a decision will follow after that.  It’s possible the FDA will want further study into the risks posed by low dosages.

For more information, follow this link.

At the beginning of this year, the Food and Drug Administration asked the makers of zolpidem (most commonly found in Ambien) to come up with new labels that clearly outline the perceived dangers of the drug.  Now, the FDA has given its approval to new labels which stipulate both a lower dosage recommendation and a greater risk to females.  The warnings also urge persons who take drugs like Ambien to take the proper precautions up to 24 hours after use.  The medication has been shown to imperil alertness the next day, and thus activities like driving should be delayed until one can be sure the drug is out of their system.

Click here for more information.

The death knell has been sounded for a San Francisco ordinance that would have required cellphone sellers to explain to consumers the danger posed by radiation emissions of said phones.  Two days ago, the city’s Board of Supervisors voted to settle a lawsuit with a cellular trade group, with only one of the Supervisors voting against the grain.  The Cellular Telecommunications Industry Association argued against the law on First Amendment grounds, and their efforts to block the law achieved their desired goal when the courts barred the ordinance’s implementation.  By agreeing to a permanent injunction, the city won’t have to pay attorney’s fees accumulated by the wireless group.  The California Brain Tumor Association’s director voiced disappointment with the decision.

For more about the struck-down ordinance, click here.

The Food and Drug Administration is looking into a substance known as triclosan in order to figure out if the anti-bacterial ingredient is truly safe.  In the United States, there’s a good chance you’ve come into contact with the ingredient, even if you don’t realize it.  It’s been estimated that triclosan can be found in three quarters of all anti-bacterial body washes and liquid soaps.  The FDA, though, has grown concerned that the product not only doesn’t provide any sort of anti-bacterial benefit, but that its presence could actually harm consumers.  That worry was highlighted by studies into the effects the product has on animals which found that animals exposed to triclosan were subject to a greater risk of infertility and hormonal issues.

Follow this link for more about the investigation.

In a new report, the Food and Drug Administration outlines the risks posed to consumers who submit to indoor tanning.  Persons who engage in this activity are estimated by the American Cancer Society to be 75% more at risk for the development of melanoma.  To help citizens become more aware of the danger, the FDA has proposed that tanning beds be reclassified as Class II medical devices that pose a moderate risk.  They also would like to see new labels outlining the skin cancer danger and warding off persons under the age of 18.  In addition, the agency explains the steps that can be taken by those who insist on tanning indoors.  One should always wear goggles and limit their time within the tanning bed.  Persons should also understand their skin type and the applicable exposure times as suggested by the manufacturer.

Click here to learn more.

The Food and Drug Administration is warning pregnant women to avoid the use of any drugs that contain valproate sodium.  Such medications, which are typically prescribed in order to treat things like seizures, bipolar disorder-prompted manic episodes, and migraines, could potentially lead the children of said pregnant women to develop lowered IQs.  Although labels on medications containing the aforementioned ingredient should already attempt to steer pregnant women clear of the drug, this latest warning is far stronger than previous prompts.  A study about the Neurodevelopmental Effects of Antiepileptic Drugs illustrated the need for such drastic warnings.  Women who get pregnant while on such a medication are advised to consult their doctor to find out about potential alternate treatment options.

To learn more about this warning, follow this link.

A consumer watchdog group known as Citizens for Health has issued a press release detailing the admission by the Corn Refiners Association of the sale of High Fructose Corn Syrup-90 to manufacturers of foods and beverages.  Citizens for Health says that this substance is currently illegal, as it has not been tested nor approved for sale by the Food and Drug Administration.  The group accuses the CRA of making misleading statements to the FDA; chiefly, they take offense at the CRA President’s claim that HFCS-90 has been added to products for years and that manufacturers can determine the safety of an ingredient without the FDA’s approval.  Citizens for Health is petitioning the FDA to crack down on the ingredient’s unapproved usage.

To learn more, follow this link.

The Food and Drug Administration has vowed to look more closely into the effects that large amounts of caffeine could have on children.  The move was prompted by the unfurling of Wrigley’s Alert Energy Gum, a type of gum that includes a decent dose of caffeine.  A Deputy Commissioner of the FDA explained that the current trend of food manufacturers adding caffeine to such products as jelly beans, chips, and more would have been unfathomable in the past.  As such, the FDA might be forced to revisit an issue that hasn’t really been considered since the 50s, when caffeine was approved for soda.  If the FDA decides that children could be negatively impacted by the proliferation of caffeine, they might take further action.

Click here for more information.

On the heels of an explosion at a West, Texas fertilizer plant, a new report looks at the debate over what should be done to prevent such catastrophes in the future.  The article points to a proposed 2009 law that would have created new safety standards  for water treatment plants and chemical and fertilizer facilities.  That bill was never brought to a vote in the Senate despite passage in the House of Representatives.  The article points to lobbying efforts as a potential reason for the bill’s failure, but safety advocates are calling for a reexamination of the issue after the aforementioned explosion.  Some believe, though, that it’s more imperative that businesses focus on following the rules that are already in place.

To learn more, click here.

Water and electricity certainly do not mix, and a new report out of Oklahoma aims to provide a few electrical safety tips geared especially toward reducing the types of injuries that occur when extensive rains lead to a potential hazard.  First, persons should not use electronics outside when the weather is rainy.  Even if the rain has cleared up, the grass might still be wet, and an electronic appliance can still pose a danger.  Instead of just keeping outdoor appliances outside when not in use, unplug them and store them in a safe place.  When you yourself are wet, stay away from circuit breakers and various appliances.  And should something like a vacuum or a lamp become damp, these must be absolutely dry before you can plug them back in.

For more tips, follow this link.

A reformulated version of Oxycontin aims to reduce the potential for abuse thanks to new properties that hinder nasal and injection-based usage, and the Food and Drug Administration has now approved labeling for the product that says as much.  Because of this, the original form of Oxycontin that did not have these abuse hindrances will be removed from the market.  Any generic forms of the drug based off of the original non-deterrent version of the medication will also no longer receive the approval of the organization.  That means that generics will now have to have the same abuse prevention mechanisms in place if they hope to reach the market.

Click here to learn more.

The Food and Drug Administration has released a report explaining to consumers what the agency is doing in order to limit the public’s exposure to DMAA, or dimethylamylamine.  This stimulant is most commonly found in dietary supplements that purport to offer such benefits as muscle enhancement and weight loss.  Unfortunately, the FDA worries that the ingredient could lead to a swath of health problems, including heart attacks or other cardiovascular issues, breathing problems, and chest tightening.  60 incident reports, including fatalities, have come to the FDA’s attention, and although the mere filing of a report does not automatically equate to a connection to DMAA, the FDA is still taking the issue seriously.  They have warned all supplement companies that including the substance within a product is illegal, and thus far, all but one has complied with a request to stop selling items with DMAA.

To learn more about the risks of DMAA, follow this link.

A recent incident in Hayden, Idaho has renewed warnings about the potential danger posed by the bristles of grill brushes.  A teenager recently required medical intervention after she swallowed one of these bristles, a phenomenon that the Centers for Disease Control and Prevention say all consumers need to be aware of.  Five instances of a bristle being swallowed after it fell off of a brush and lodged in a piece of food were reported last year, and the doctor involved in the aforementioned incident explains that a bristle can lead to a serious infection if stuck in the tongue, intestines, or esophagus.  To prevent an injury, the CDC asks brush owners to take a wet rag to a grill after brushing it so that fallen bristles can be swept away prior to grilling.

To learn more about the risks, click here.

One would think that the Food and Drug Administration only approves drugs for use after they have weighed the results of all clinical trials conducted in regards to the medication.  But a new article shows that this isn’t always the case thanks to one big oversight:  when a trial has results that might be construed as negative, those carrying out the trial tend to hold that study back from publication.  As a result, only positive trials get widely reported, meaning that the FDA could have its hands somewhat tied by not being exposed to all available information.  An author describes how a campaign known as AllTrials seeks to change this potential publication bias by lobbying safety advocates and drugmakers alike to call for a change to the way things are done.  Two months ago, GlaxoSmithKline, a major drugmaker, signed a pledge to provide all trial data.

Click here to learn more.

More and more people are growing concerned that the da Vinci Robotic Surgical System is putting certain patients in danger.  Citing a rash of problems occurring while these items were being used during surgical procedures, the Food and Drug Administration will be looking closer at the robots to determine if unwarranted risks exist.  Five fatalities have been reported in conjunction with the da Vinci since the beginning of 2012, and other incidents have also come to the fore.  Some medical professionals think that more research should be conducted to determine if the item from the Sunnyvale, California-based Intuitive Surgical is as effective as a regular surgeon.  Amid the incidents reported are a robotic claw refusing to let go of a patient and a patient getting struck in the face.  367,000 operations were carried out with a robot last year alone.

Click here to learn more about the device.

If you plan on renovating your home any time soon, then you might want to make yourself aware of a new report from Consumer Reports.  The organization explains that such remodeling projects typically release dust and chips of paint that tend to carry heavy amounts of lead.  It’s thus recommended that all homes submit to a lead test with  a kit approved by the Environmental Protection Agency before renovations begin.  Consumers can also work with a licensed contractor who understands applicable laws pertaining to lead.  535,000 or so children between the ages one and five reportedly have levels of lead in their blood that are above what’s been deemed acceptable, but taking the necessary precautions might protect your own children.  Parents might also purchase a water filter to eliminate lead from drinking water.

To learn more about the threat, click here.

An armed forces minister in the United Kingdom is reportedly among those who have been negatively impacted by an implantation with the DePuy ASR metal on metal hip implant.  Five years after receiving one of these devices, the former soldier reportedly incurred a non-cancerous tumor, which his doctor suggested resulted from the implant. This particular individual has been told that, in order to correct the pain he feels when standing or climbing the stairs, a revision surgery will be necessary.  The minister is one of the 10,000 or so British recipients of the device.  As in the rest of the world, the DePuy ASR has been recalled in the United Kingdom.  Thousands of lawsuits have been filed in conjunction with problems stemming from the device.

Click here to learn more.

Concerns over sterility have prompted Clinical Specialties to announce the recall of all sterile items.  Every lot that was repackaged and then shipped around the country is affected by the recall, which actually stems from an earlier recall involving compromised Avastin from the compounding firm.  After receiving the Avastin, five persons reportedly experienced serious eye infections known as endophthalmitis infections.  The Centers for Disease Control related these diagnoses to the Food and Drug Administration.  The nature of the infection is such that it could lead to vision loss.  With the sterility of the Avastin potentially compromised, Clinical Specialties has decided to recall all products.  Any adversity associated with any of the items should be reported to MedWatch.

Follow this link for more about the recall.