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.

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.

Blood Glucose Meters under the Freestyle Insulinx brand are being recalled by Abbott because of an issue that could impede proper patient therapy.  The items, which measure blood sugar levels via a finger prick, could cease to work properly if the individual is suffering from the abnormally high blood glucose level of 1024 mg/dL.  When this occurs, the devices are in danger of actually subtracting the 1024 figure from the actual amount, thus displaying a level that is far less than what the patient’s glucose is currently at.  Consumers might then not seek out the medical intervention that would be advisable when blood glucose levels are that high.  Consumers are advised to update their software via the Freestyle Insulinx website or to get in touch with Abbott to obtain a free replacement item.

Click here for more about the recall.

A number of items are being recalled by a compounder once again, this time because a certain component involved in the compounding procedure can’t have its sterility assured.  Pentec Health announced the recall, which affects nutritional prescriptions provided to 163 renal patients receiving dialysis in either a home or hospital setting.  Each prescription would have been compounded in a certain laminar flow hood whose sterility might have been compromised.  No instances of adversity have been reported at this time, and Pentec explains that sterility tests have yet to turn up a problem.  Affected products would have been compounded prior to May 2.  Patients who know their prescription came from Pentec are advised to get in touch with their doctors if they have questions.

For more about the recall, click here.

The Food and Drug Administration is attempting to steer healthcare professionals and patients alike away from any sterile products hailing from the Dallas, Texas-based NuVision Pharmacy.  This past April, that company recalled certain injection products because of concerns that sterility could not be guaranteed, and since then, the FDA has been the recipient of reports detailing such adversity as fever, soreness, and symptoms often associated with the flu.  A recent facility inspection uncovered the types of manufacturing procedures that could compromise the sterility necessary to ensure the safety of the drugs.  Doctors are being asked to comb through their inventory to look for the medication.  If found, they should be quarantined and kept away from patients to prevent an infection.

Click here for more about the recall.

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.

Many doctors are touting the benefits of a device that aims to drastically reduce lacerations to newborn children when a Caesarean section is required.  With nearly a third of all modern pregnancies involving a C Section, healthcare professionals have grown increasingly concerned about the possibility of deep cuts or even amputations when a standard scalpel is used.  Enter the C SAFE, which utilizes blunt plastic to open an incision before moving outward as opposed to inward with the blade.  One Los Angeles-area OBGYN extolled the virtues of this new method of conducting a C-section.  She herself has a daughter who was cut when being delivered via C-section using traditional means, and thus she’s been recommending the new method to patients.

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Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 with lot numbers ranging from 5030B23 to 503C020 have been recalled by the Weston, Florida-based Apotex Corporation.  A total of 21 lots are impacted, as each could suffer from crystallization or precipitation in the IV Line or IV bag.  This could cause a host of patient safety issues, such as renal impairment, vasculitis, and more.  Proper therapy could also be impeded because of the issue, which could prompt an infection to remain and grow.  No instances of adversity have been reported at this time, and to ensure that continues, healthcare professionals should be on the lookout for notification from Apotex.  In the meantime, the drugs should not be administered.

For more about the recall, follow this link.

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.

This week, Wrigley introduced the world to a caffeinated gum product, and with concerns mounting about the prevalence of caffeinated food items that could potentially be tempting to children, the Food and Drug Administration has decided to look into the matter.  In a new interview, the Deputy Commissioner of the Foods and Veterinary Medicine branch of the FDA explains the FDA’s decision.  The agency hasn’t revisited the caffeine issue since the 50s, as up until now, no one really thought that caffeine would explode among food products the way it has.  But now, the FDA wants to look into what effect so many caffeinated items could have on kids and potentially enact rules that would protect such susceptible individuals.  Considerations could include banning caffeine from certain foods and putting restrictions on the amount of caffeine that could be put in a product.

For more about the FDA’s efforts, click here.

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.

13086, 13087, 13088, 13150, 13100, and 13000 models of GemStar Infusion Systems have been recalled by Hospira because of an issue that could prevent the continued operational capacity of the device.  Used to provide infusion in a home or hospital setting, the devices could potentially sustain an 11/004 error when the lithium battery is lower than 2.4 volts.  As a result, the product would cease to function and the patient would not receive the therapy they require.  Plus, the device’s memory will be wiped of previous settings and a recording of events.  Owners of the devices, which were available between February 1999 and this month, are advised to get in touch with Hospira to learn if they should replace their battery.  This replacement should typically be sought if the battery is more than three years old.

For more about the recall, click here.

An entity based in Chico, California called Currey & Company has announced the recall of six different models of chandelier because of a shock threat posed to consumers.  On 2,200 of these metal and crystal chandeliers, which were available in Canada and the United States until this past February, the wiring could suffer from a defect which leads to the transmission of electricity into the metal area of the chandelier where it doesn’t belong.  A person could thus be shocked, although no such reports have arisen at the moment.  The chandeliers should not be used; instead, they should be brought back to the company.  Barring that, an owner could contact Currey & Company to set up a no-cost repair.

Click here for more about the recall.

A new report from the Food and Drug Administration details the research efforts of the Office of Minority Health.  It’s the office’s duty to make sure that the effect a given drug or medical product will have on minority populations is taken into account when the FDA is evaluating such items and formulating regulations.  For example, the OMH is using new methods of molecular blood typing to reduce the risks that crop up with the ongoing treatment of sickle cell disease, which requires multiple blood transfusions that can leave an individual sensitive to antigens and resistant to said transfusions.  The office is also seeking to use genetic testing to figure out what levels of warfarin would be safe for a patient, as well as a host of other issues.

To learn more, follow this link.

148,700 Lasagna Pans stamped with the phrase “Giada De Laurentiis by Target” are being recalled by Target and by Wilton Industries, a company based in Woodbridge, Illinois.  Sold only at Target as an individual unit or as part of a half dozen piece set, the items are in danger of breaking.  Should this condition make itself known, the persons handling the pan could find themselves being cut by the sudden sharp edges that can spring up.  39 instances of a crack or break have been reported, and six of those led to an injury.  Owners are being asked to bring back the individual pan (as opposed to the entire set) to obtain a refund.

Follow the link to learn more about the Lasagna Pan recall.

Versions of the Alaris PC Unit (a component of the Alaris electronic infusion pump) with a software level of 9.12 are being recalled by CareFusion Corporation because of the possibility of a Communications Error.  This situation presents itself when the user toggles between different screens.  An alarm accompanied by a blinking red light will emanate, at which point users will be unable to execute commands on the device other than to turn it off completely.  Infusion will continue during the error mode, but once the item is turned off, even this will cease.  Medical professionals are being asked to weigh the risks against the benefits of disabling the device before they take action.  If they determine that the product poses too great of a threat, then it should not be used until such time that CareFusion can offer repairs.

Click to learn more about the recall.

Another compounder has recalled all sterile products because there is a possibility that they may pose a risk to patients.  The recall was issued by Balanced Solutions Compounding Pharmacy and pertains to each of their compounded sterile items that have yet to expire.  The Food and Drug Administration recently tested chromium chloride injection, which itself was recalled, and found that it contained gram negative bacteria.  Worries about the safety of other products has thus prompted this widespread recall.  No illnesses have been reported at this time, but those persons exposed to a contaminated product could find themselves facing a serious infection.  Concerned parties should speak with their doctor, and medical professionals should get in touch with BSCP to learn about recall instructions.

To learn more about the recall, click here.

ShapeMatch Cutting Guides used during total knee replacement surgeries have been recalled by Stryker because the products could allow for cutting ranges that are greater than what is acceptable during the procedure.  Because of a software defect, the actual parameters of the guide might not be in line with what the surgeon planned prior to the operation, or they might display information that also doesn’t match what is actually produced.  44 incidents have been reported, three of which caused injuries that were apparently treated shortly after the inappropriate cut.  A patient privy to such an error could face a fracture, instability of their joint, and severe pain and mobility reduction that could prompt a revision surgery.  Any person who recently underwent a knee replacement surgery should speak with their doctor the moment they start to feel any of the aforementioned issues.

To learn more about the recall, click here.