FDA: Lunesta Starting Dosage Must Be Reduced

The FDA has announced that it is requiring the manufacturer of Lunesta, a popular sleep aid, to change the drug label and lower the current recommended starting dose out of concern that it may impair some users' abilities to perform activities the morning after usage, even if they feel fully awake.

The recommended starting dose for Lunesta has been reduced from 2 mg to 1 mg for both men and women. The lower starting dose will mean that less of the drug remains in the bloodstream the next morning. Users who are currently taking the 2 mg and 3 mg doses of Lunesta should contact their doctors for instructions on how to proceed.

The dose change follows a study that showed that Lunesta 3 mg is associated with severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug. The study found that the recommended doses can lead to impaired driving skills, memory and coordination up to 11 hours after the drug is taken. Many users were unaware that they were impaired.

The dosage and label changes will also apply to generic versions of Lunesta.

To learn more, click here.

FDA: Uncle Ben's Recall Affects Nursing Homes

The FDA has announced that an Uncle Ben's recall made earlier this week affects not just individual consumers but nursing homes, hospitals, schools and other institutions as well.

The recall includes all bags and all lot numbers of Uncle Ben's Infused Rice products made in 2013. One of the recalled products, Uncle Ben's Infused Mexican Rice Flavor, has been linked to illnesses at three public schools in Texas. Students and teachers who consumed the rice reported itchy rashes, headaches and nausea for 30 to 90 minutes.

To read the complete FDA notice, click here.

FDA Asks Healthcare Professionals to Stop Prescribing Combination Drug Products Containing More Than 325 Mg of Acetaminophen

On January 14, the FDA recommended that healthcare professionals stop prescribing and dispensing combination drug products that contain more than 325 milligrams (mg) of acetaminophen.

According to the agency, there is no data that shows taking more than 325 mg of acetaminophen per dosage unit provides additional benefits that outweigh the risk for liver injury. They also note that limiting the amount of acetaminophen consumed will reduce the risk of severe liver injury from inadvertent overdose, which can lead to liver failure, liver transplant and death.

The FDA is recommending the following:

• That healthcare providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen 
• That pharmacists call prescribers to discuss a product with a lower dosage of acetaminophen when they receive a prescription containing more than 325 mg of acetaminophen
• That prescribers always consider the amounts of both acetaminophen and opioid components when making individual dosing determinations

To learn more, click here. 

FDA Scrutinizing Antibacterial Soaps

In December, the FDA announced that it plans to take a closer look at antibacterial hand soaps and body washes to determine if they provide benefits beyond those of "plain" (non-antibacterial) soaps. The FDA notes that there is currently no research that supports these soaps being any more effective at preventing illness.

The agency is also concerned that chemicals commonly contained in these soaps, such as triclosan and triclocarban, might carry unnecessary risks, such as bacterial resistance to antibiotics and hormonal effects.

What you need to know now:

• Under the FDA's proposal, manufacturers of antibacterial soaps would be required to provide more substantial data to demonstrate the safety and effectiveness of antibacterial soaps.
• The proposed rule would only cover consumer-grade antibacterial soaps and body washes that are used with water. It would not apply to antibacterial soaps that are designed for use exclusively in healthcare settings or alcohol-based hand sanitizers or hand wipes.
• The agency is asking consumers, clinicians, environmental groups, scientists, industry representatives and others to weigh in on this proposal in the next 180 days.

At this point, the FDA's proposal is preliminary and the agency has not officially recommended that anyone discontinue use of antibacterial soaps.

ProMed will continue to closely monitor this issue and share any updates with you. You should also know that our DermaKleen antibacterial hand soap does not contain triclosan or triclocarban. Our territory managers are ready to help you choose the ideal product for your needs as well as address any concerns you might have. To connect with us, give us a call at (800) 648-5190 or visit us online at promedsupply.com.

To learn more, click here.

FDA Scrutinizing Antibacterial Soaps

On Monday, the FDA issued a proposed rule that would take closer look at antibacterial hand soaps and body washes to determine if they provide benefits beyond those of “plain” (non-antibacterial) soaps. The FDA notes that there is currently no research that supports these soaps being any more effective at preventing illness.

The agency is also concerned that chemicals commonly contained in these soaps, such as triclosan and triclocarban, might carry unnecessary risks, such as bacterial resistance to antibiotics and hormonal effects.

The FDA is proposing that manufacturers of antibacterial soaps be required to provide more substantial data that demonstrates the safety and effectiveness of antibacterial soaps. The agency is asking consumers, clinicians, environmental groups, scientists, industry representatives and others to weigh in on this proposal in the next 180 days, so it will be some time before a final rule is issued.

We want you to know that ProMed offers a complete range of hand soaps that do not contain triclosan, including DermaKleen. Our knowledgeable sales team is ready to meet with you to discuss your needs and help you select the best products for your facility.

We will continue to monitor the progress of this proposed rule and keep you updated.

For additional information  from the FDA, please click here.

FDA Propses "Action Level" for Arsenic in Apple Juice

The FDA has proposed an "action level" for arsenic in apple juice. This level, 10 parts per billion (ppb) is the same level that the EPA set for arsenic in drinking water.

The agency stresses that the levels of arsenic in apple juice are very low, but that by setting an action level, they are hoping to prevent public exposure to occasional lots that contain arsenic levels above those permitted in drinking water.

The action level is designed to act as guidance to the apple juice industry. The FDA will take the action level into account when considering enforcement action if it finds that a product exceeds the allowed level of arsenic.

Inorganic arsenic may be found in food because it is present in the environment, both as a naturally occurring mineral and due to past use of pesticides containing arsenic. Arsenic is a known carcinogen and has also been linked to skin lesions, developmental problems, cardiovascular disease, neurotoxicity and diabetes.

To learn more, click here.

FDA Moves to Fast-Track C. diff Treatments

The FDA has proposed a regulation that would fast-track potential treatments for C. diff, calling the infection a serious public health threat.

The proposed rule would enact a provision of the Food and Drug Administration Safety and Innovation Act of 2012 known as Generating Antibiotic Incentives Now, or GAIN. The provision allows fast-tracked review of antibiotics and antifungal drugs designed to treat especially dangerous pathogens. It would also extend the market exclusivity of these drugs by five years.

C. diff is one of 18 pathogens that have been identified for GAIN inclusion.

To learn more, click here.

Could Your Damaged Mattress Covers Lead to Infection?

On April 19, the FDA released a Safety Alert to warn healthcare professionals about the risk of contamination and infection associated with damaged or worn mattress covers. The agency noted that it is concerned that this risk is both widespread and under-recognized.

According to the alert, the FDA received 458 reports between January 2011 and January 2013 of medical bed mattress covers failing to prevent blood and other body fluids from leaking into mattresses. This leakage can occur when mattress covers become worn or damaged by incorrect cleaning, disinfecting and laundering. Zippers on mattress covers can also allow fluid to penetrate mattresses.

Some of the reports that the FDA received indicated that if a mattress becomes contaminated by the body fluids of one resident, those fluids can later leak out when another resident is placed on the mattress, putting that resident at risk for infection.

The FDA recommends performing the following mattress inspections and maintenance:

•  Regularly check each medical bed mattress for any visible signs of damage or wear, such as cuts, tears, cracks, pinholes, snags or stains.
•  Routinely remove the medical bed mattress and check its inside surface. Once the mattress cover is removed, inspect the mattress for wet spots, stains or signs of damage or wear. Check all sides and the bottom of the mattress as well.
• Immediately replace any medical bed mattress cover with visible signs of damage or wear to reduce the risk of infection.
• Do not stick needles into a medical bed mattress through the mattress cover.

To read the Safety Alert in its entirety, click here.

If you discover that any of the mattresses in your facility need to be replaced, please reach out to your ProMed territory manager. We have a complete line of support surfaces to meet all of your residents’ needs. You can also connect with us by calling (800) 648-5190. 

Congress Introduces Bills to Limit Hydrocodone Access

After receiving notice from the FDA that reclassifying hydrocodone to be a Schedule II drug (it's currently Schedule III) would be a lengthy process, Congress has taken the agency's recommendation and introduced a bill to more quickly reclassify the drug.

Bipartisan bills have been introduced in both houses of Congress. The bills are cosponsored by 42 members of both parties.

The goal of the bills is to combat growing prescription drug abuse. If the legislation passes, people will no longer be able to refill hydrocodone prescriptions by fax or phone and long-term care operators might have to store the drug differently. Opponents have argued that the reclassification will just make it more difficult for people who are in pain to receive the drug.

To learn more, click here.

FDA Investigating Link Between Popular Diabetes Drugs and Pancreatic Cancer

The popular diabetes drugs Januvia and Byetta, which were previously connected to an increased risk of pancreatitis, are now under investigation by the FDA to determine if they are associated with pancreatic cancer.

The FDA said that researchers have found precancerous changes on the cellular level in pancreatic tissue specimens from deceased users of Januvia and Byetta.

The FDA is encouraging users of the drugs to continue taking them as directed by their healthcare providers, but they are encouraging users and physicians to be alert to adverse events and report them to the FDA MedWatch program.

To learn more, click here.

FDA: It's a Long Process to Restrict Access to Painkillers

Advocates for restricting access to hydrocodone painkillers might need to cool their heels for a while. The FDA has told lawmakers that it will be a lengthy process unless Congress takes action.

In February of 2013, a bipartisan group of five senators and two representatives urged the FDA to promptly change hydrocodone painkillers, such as Vicodin, from Schedule III to Schedule II drugs to help address the nationwide epidemic of painkiller addiction. For this to happen, the Drug Enforcement Agency (DEA) would first need to publish information about the change in the Federal Register and then wait for public comment. The FDA would also be required to conduct additional research as part of the reclassifying process.

To speed up the process, the FDA said that Congress would need to pass legislation mandating the change.

To learn more, click here.

Popular Antibiotic Azithromycin Could Lead to Potentially Fatal Heart Rhythms

The FDA issued a warning on Tuesday that azithromycin (also known as Zithromax, Zmax or the Z-Pak) can cause abnormal changes in the electrical activity of the heart that might lead to a potentially fatal irregular heart rhythm. The drug's label has been updated to include this risk.

The FDA is encouraging physicians to consider this risk when prescribing the drug to patients who are already at risk for cardiovascular events. Such patients include those with existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate or use of certain drugs used to treat abnormal heart rhythms.

To learn more, click here.

Legislators Urge FDA to Act Faster on Painkiller Restrictions

Congressional lawmakers, in a letter, are urging the FDA to speed up their plans to tighten access to hydrocodone painkillers, including Vicodin. The letter was written by Senator Joe Manchin of West Virginia and signed by a bipartisan group of five other senators and two representatives.

Last month, an FDA advisory committee voted in favor of tightening restrictions on the highly addictive painkillers. The new restrictions would require that hydrocodone be stored in vaults at healthcare facilities and would require that patients receive new prescriptions for refills, which they would not be able to obtain by fax or phone. It would also prevent nurse practitioners and physician assistants from prescribing hydrocodone.

Critics have said that the refill requirement would be a burden to nursing home residents with limited mobility, who would have to visit their doctors to receive the drugs.

To learn more, click here.

St. Jude Medical Recalls Heart Implant Tool

St. Jude Medical has recalled the AMPLATZER TorqVue FX Delivery System, a tool that is used to to help mend a type of heart defect that causes holes in the upper chambers of the heart. The FDA is classifying the action as a Class I recall, meaning that patients treated with the devices could be seriously injured or killed.

The recall comes after a small number of incidents in which the delivery system's wire fractured during surgery. The recalled devices were manufactured between August 24 and September 24 of 2012.

To learn more, click here.

FDA Okays Botox as Treatment for Overactive Bladder

The FDA has approved Botox as an effective treatment for overactive bladder after two clinical trials involving more than 1,100 patients.

During the studies, participants whose bladder muscles were injected with Botox experienced between 1.6 and 1.9 times fewer daily episodes of incontinence compared to those who received the placebo injection. Those who received the Botox injections also had less frequent urges to urinate and produced more urine than the placebo group.

The Botox injections relax the bladder muscle, increasing the bladder's storage capacity.

To learn more, click here.

Generic Lipitor Recalled Over Glass Particles

Ranbaxy Pharmaceuticals Inc. has recalled more than 40 batches of its generic version of Lipitor after warning that the medication might contain small particles of glass.

The recall applies to to bottles of 10-, 20- and 40-milligram tablets of atorvastatin calcium, the generic version of Lipitor. According to a statement from Ranbaxy, "The recall is being conducted at the retail level for such select batches that may contain a foreign substance (small glass particles less than 1 mm in size). Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind."

To view a full list of the recalled lots, click here.

To learn more, click here.

FDA Encourages Healthcare Providers to Contact Patients Who Received Injectables from NECC in Wake of Fungal Meningitis Outbreak

The FDA is recommending that medical professionals reach out to any patient who was administered an injectable product distributed by the New England Compound Center (NECC). This comes on the heels of a fungal meningitis outbreak being tied to steroids distributed by the NECC.

At this point, the fungal meningitis has been traced to injections of  methylprednisolone acetate as well as triamcinolone acetonide. NECC has issued a recall of all of its products (to view the list of affected products, click here).

Since the outbreak began, the FDA has has been conducting an ongoing investigation into contamination at  NECC, which is located in Framingham, Massachusetts. As a result of this investigation, they have recommended that healthcare professionals retain NECC products, secure them and withhold them from use. They are also advising them to follow up with any patient who received an injectable drug from NECC and asking them to be on the lookout for symptoms of possible infection, including fever, swelling, increasing pain, redness, warmth at the injection site, chest pain, drainage from the surgical site, visual changes and redness or discharge from the eyes. If patients notice any of these symptoms, they should contact a healthcare provider immediately.

At this time, the FDA is not urging patient follow-up for those who received non-injected NECC drugs, such as lotions, creams, suppositories and eye drops not used in conjunction with surgery.

To learn more and stay up to date on any new developments, click here.

Generic Version of Wellbutrin Pulled Off the Market

The FDA has asked Teva Pharmaceuticals to pull its generic version of the popular antidepressant Wellbutrin  XL 300 mg off the market after discovering that the generic version releases its key ingredient faster than the original drug.

The generic version, Budeprion XL 300 mg, was pulled after hundreds of reports that the drug did not work or caused side effects including headaches, anxiety and insomnia.

There are four other generic versions of Wellbutrin XL 300 mg that have been approved by the FDA.

To learn more, click here.

FDA Launches BeSafeRx to Raise Awareness of Unsafe Internet Pharmacies

The FDA has launched BeSafeRx: Know Your Online Pharmacy, a national campaign aimed at raising awareness of Internet pharmacies and their potential risks to consumer health.

According to the FDA, some Internet pharmacies may sell fake, expired, contaminated, non-FDA-approved or otherwise unsafe products.

According to BeSafeRx, the following should raise red flags about online pharmacies:

• Allow you to buy drugs without a prescription from your doctor
• Offer deep discounts or cheap prices that seem too good to be true
• Send spam or unsolicited email offering cheap drugs
• Are located outside the United States 
• Are not licensed in the United States 

The BeSafeRx site also contains a state-by-state directory of safe online pharmacies. 

To learn more about BeSafeRx, click here. 

FDA Warns That Pain Relief Creams Can Cause Chemical Burns

The FDA is warning consumers that popular topical pain relief products, such as Icy Hot, Bengay, Capzasin, Flexall and Mentholatum, can cause burning pain and blistering. The agency says it has received more than 40 reported cases of injury. The products, which are typically used to soothe mild muscle and joint pain, have been linked to mild to severe chemical burns.

The agency notes that the number of reported adverse reactions is very small when compared to the number of products that are purchased and adds that there is no way to predict which individuals would have this kind of severe reaction.

The FDA has the following advice for consumers who use topical muscle and joint pain relievers:

• Don't apply the products to damaged or irritated skin.
• Don't place bandages over skin where you've applied the products.
• Don't combine the products with heating pads, hot water bottles or lamps (this can increase your risk of serious burns). 
• Don't allow the products to come into contact with mucous membranes (such as your nose, mouth or genitals).
• If you feel any actual pain after applying the products (not just the expected warming or cooling sensation), look for signs of blistering or burning. If you see any of these signs, stop using the product and seek medical attention.
• If you have concerns about using a topical pain relief product, talk to a medical professional first. 
• If you experience any unexpected side effects, report them to the FDA's MedWatch program.

To learn more, click here.