Devices Claimed To Improve Safety Are Dangerous

Main Category: Medical Devices / Diagnostics
Also Included In: Public Health;  Sleep / Sleep Disorders / Insomnia
Article Date: 22 Nov 2012 – 0:00 PST

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Portable bed rails marketed to “make any bed safer” actually increase the risk of injury and death, according to an article in Biomedical Safety & Standards (BS&S). A newsletter for medical device safety professionals, BS&S is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

Two consumer watchdog groups have requested the Federal Trade Commission (FTC) to order one manufacturer to stop making false advertising claims regarding the safety of its portable bed rail. A front-page feature in BS&S reports on the request and provides background on the safety concerns related to the use of such products.

Bed Rails Linked to Deaths – Request to Stop False Advertising

In September, two groups sent a formal letter to the FTC requesting that one manufacturer be stopped from making false safety claims for its portable bedrails. Last year, one of the groups petitioned the U.S. Food and Drug Administration (FDA) to ban marketing and order a recall of specific bed rail models; to assess the design and use of similar bed handle or bed rail devices; and to investigate the risk of life-threatening injury or death from entrapment, strangulation, or positional asphyxia and ban other devices as appropriate.

The request cites more than 525 deaths associated with bed rail use that have been filed with the FDA, along with more than 155 deaths reported to the Consumer Product Safety Commission (CPSC). There are multiple “entrapment zones” with the use of a bed rail, each with a risk of causing death by asphyxiation. This entrapment risk can be a fundamental feature of the design of the rail openings or may arise from how the bed rail attaches to the bed.

Meanwhile, the manufacturer continues to make safety clams, such as that its product “makes any bed a safer bed.” In the petitions, the FTC is asked to order the manufacturer to stop making these unproved safety claims. Other portable bed rails on the market present similar safety issues.

Previous CPSC standards addressing bed rails for children and toddlers have led to sharp reductions in injuries and deaths in young children. However, the standards don’t apply to products intended for adults – especially older adults, for whom falls are a common and potentially catastrophic event.

There’s no evidence that side rails safely prevent falls, whereas other measures – such as lowering the bed and using anti-slip matting – are effective. “A fall with a bed rail in place is more dangerous than a fall without a rail, because of the change in trajectory of the fall,” according to the article in BS&S.

Although hundreds of deaths have been reported, it is likely that the true number of incidents is substantially higher. Home users and even some health care professionals may be unaware that such events should be reported to the FDA or CPSC. (Or if they are aware, they may not be motivated to report.) The BS&S feature article concludes, “Given portable bed rails are often sold directly to consumers and through medical supply stores, consumer groups think the CPSC and the FDA, both of which have been petitioned for rulemaking repeatedly in these matters, should be taking action to regulate, force recalls, and effectively ban marketing and sales of the dangerous devices.

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22 Nov. 2012. <http://www.medicalnewstoday.com/releases/253026.php>


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More Drug Shortages in Fungal Meningitis Aftermath

ampule and syringe

Nov. 2, 2012 — Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.

Ameridose — the sister firm of the NECC, the compounding pharmacy whose tainted products are at the heart of the outbreak — has shut down, and at the FDA’s urging recalled the more than 2,000 products it sold nationwide. The FDA yesterday admitted that these actions will worsen the ongoing shortage of six important drugs hospitals need to help critically ill patients.

Currently, 226 drugs are in short supply. Last year, 99% of U.S. hospitals reported drug shortages. And these are important drugs, says Joseph Hill, director of federal legislative affairs for the American Society of Health-System Pharmacists.

“In the last five years we have seen a significant spike in the number and severity of shortages,” Hill says. “It is really alarming when you look at the classes of drugs involved: cancer drugs, heart drugs, pain drugs, and anesthetics. Imagine not being able to perform an emergency surgery.”

Compounding pharmacies do not make most of the drugs that are in shortage. But they make an increasing number of them, says David Miller, RPh, CEO of the International Academy of Compounding Pharmacists (IACP).

“What we have seen is on a large scale, important drugs being in shortage — and not for short periods, but in the months-to-years range,” Miller says. “Compounding pharmacies help with that. Now, instead of filling short-term needs, compounding pharmacies are being looked to on a larger scale.”

How many compounding pharmacies are doing this? The FDA does not know.

“We do not have this data,” says FDA public information officer Sarah Clark-Lynn via email.

“It is important to note that compounded drugs can serve an important public health need if a patient has a particular medical need that cannot be met with an FDA-approved drug,” Clark-Lynn says. “Compounded drugs that are prepared improperly pose potential health risks to the patients who take them. When such compounding occurs on a large scale, more patients are exposed to those risks.”

Compounding Pharmacy Safety

It’s impossible for a hospital running out of crucial drugs to know if a compounder is safe, says Michael Cohen, RPh, president of the Institute for Safe Medication Practices (ISMP).

“I cannot to this day clearly see anything that articulates what pharmacies are provided with the oversight to ensure that they’re making these drugs safely and what pharmacies are not,” Cohen testified before the FDA’s September 2011 workshop on drug shortages.

A full year before the fungal meningitis outbreak, Cohen warned the panel that unsterile drugs made by compounders already had caused infections and deaths — and that the oversight needed to prevent future disasters was “not happening.”

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FDA Finds Mold, Germs at Compounding Pharmacy

Contaminated Steroid Shots From Pharmacy Have Killed 25

meningococcus

Oct. 26, 2012 — “Greenish black foreign matter” in supposedly sterile drug vials. Germs growing in steroid vials supposedly tested for sterility. Mold growing in the “clean room” where drug vials were filled.

These are just some of the observations made during an FDA inspection of New England Compounding Center (NECC). The Massachusetts compounding pharmacy’s products appear to be the source of the ongoing fungal meningitis outbreak.

As of today, there have been 331 cases of fungal meningitis and seven joint infections caused by tainted steroids made by NECC. So far, 25 people have died.

It’s not a final report. In a news conference, FDA officials refused to draw any conclusions from the findings. But the observations made by the FDA’s inspection team paint an unsettling picture.

Among the findings:

  • In a bin holding 321 vials of methylprednisolone from the lots implicated in the outbreak, 83 vials contained “greenish black foreign matter” and 17 contained “white filamentous material.”
  • The NECC said its sampling showed that a batch of methylprednisolone was sterile. The FDA tested 50 vials from this lot and found living “microbial growth” in all 50.
  • The so-called “clean room” where the NECC’s sterile products were put into vials had mold and bacteria growing on many surfaces.
  • The autoclave, a device that uses heated steam to sterilize products, had “greenish yellow discoloration” and “tarnished discoloration” on the inside.
  • The NECC plant’s heating and air intake is 100 feet from a recycling facility where heavy equipment throws up dust. “Dark particulate and white, filamentous substances” covered the air ducts behind one of the autoclaves used to sterilize products.
  • There were puddles of water near a boiler close to the prep room where products were prepared. Wet floor surfaces “appeared to be soiled with thick white debris and thick black granular material.”
  • The air conditioner in the clean room is supposed to be on all the time to control humidity, temperature, and air pollution. But the NECC turned the clean room’s A/C off at night.

One of the safety steps used in drug making is to make sure the gloves worn by people in the clean room are sterile. After finishing a product, workers press their gloved fingers into a culture dish (called a touch plate) that can be tested for germs.

FDA tests found mold and or bacteria growing in touch plates from workers who had prepared products (low-dose Avastin, for example) not currently suspected of causing fungal infections.

Inspection ‘Part of a Broader Investigation’

Before the FDA takes any action, it will consider this inspection report in combination with a formal Establishment Inspection Report and other relevant data.

The inspection is “part of a broader investigation where the agency characterizes findings and draws conclusions,” Howard Sklamberg, FDA deputy commissioner for regulatory affairs, said today at a news conference.

Sklamberg and other FDA officials repeatedly refused to answer reporters’ questions about the implications of FDA inspection report. But he hinted that the FDA is deeply concerned.

“Manufacturers and compounding firms have a responsibility to manufacture quality drugs and to ensure there is not a breakdown in the manufacturing processes that causes contamination,” he said.

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Epilepsy Drug Fycompa Approved by FDA

WebMD Health News

ct scan of human brain

Oct. 24, 2012 — Fycompa (perampanel) has received FDA approval for the treatment of partial onset seizures among epilepsy patients aged 12 and older.

The new drug is the first of a new class of epilepsy medications and joins the ranks of other medications available to the estimated 2 million Americans with epilepsy. More than one-third of people with epilepsy experience seizures despite taking currently available treatments, according to the CDC.

“Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using,” says Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available for patients with epilepsy.”

Epilepsy is the fourth most common neurological disorder following migraine, stroke, and Alzheimer’s disease, according to the Epilepsy Foundation. The chronic condition causes seizures brought on by abnormal electrical activity in the brain. Seizures can affect movement, the senses, emotions, and behavior.

Partial seizures, the type that Fycompa is designed to treat, are the most common type of seizure. About 60% of epilepsy patients have partial seizures, which involve only one part of the brain. They can, however, spread throughout the brain, becoming what’s referred to as generalized seizures.

In three clinical trials, Fycompa significantly reduced the frequency of partial seizures compared to placebo. But the drug does come with a host of potential side effects, including a boxed warning about serious, possibly life-threatening neuropsychiatric side effects. These include:

  • Irritability
  • Aggression
  • Anger
  • Anxiety
  • Paranoia
  • Euphoric mood
  • Agitation

A few patients exhibited violent thoughts and threatening behavior. Patients should be monitored for such side effects during the early course of treatment, as their bodies adjust to the new medication.

The most common side effects of Fycompa include:

  • Dizziness
  • Drowsiness
  • Fatigue
  • Irritability
  • Falls
  • Upper respiratory tract infection
  • Weight gain
  • Vertigo
  • Loss of muscle coordination (ataxia)
  • Gait disturbance
  • Balance disorder
  • Anxiety
  • Blurred vision
  • Stuttering (dysarthria)
  • Weakness (asthenia)
  • Aggression
  • Excessive sleep (hypersomnia)

The drug, manufactured by New Jersey-based Eisai Inc., is a once-a-day tablet to be taken at bedtime in doses ranging from 2 mg to 12 mg. According to an Eisai news release announcing its approval, the FDA has recommended that Fycompa be classified as a scheduled drug. That means it has the potential for abuse or addiction and that its distribution will be tightly controlled.

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New Warnings in Fungal Meningitis Outbreak

telephone

Oct. 15, 2012 — More patients — not just those who got steroid shots — will be getting calls from their doctors warning them they might have a dangerous fungal infection.

The FDA now suspects fungal contamination is possible in all of the supposedly sterile products made by the New England Compounding Pharmacy (NECC) on or after May 21, 2012. People who got shots of any of these medicines — particularly those given during eye treatments or heart surgery — are at risk.

There’s already one possible case of fungal meningitis in a patient who received a different NECC steroid product (triamcinolone acetonide) than the three lots of methylprednisolone known to have infected patients.

Two people who received an NECC heart medication during transplant surgeries have fungal infections. The heart drug is called cardioplegic solution and is used to temporarily stop the heart during open heart surgery. [EDITOR’S NOTE: On Oct. 16, the FDA revised the report. Only one patient with a fungal infection had received the NECC solution.]

It’s not clear whether those infections came from the NECC drug or something else. So far, there have been no reported cases of eye infections linked to NECC products.

“At this point in FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC, are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection,” the FDA today warned in a statement.

The CDC now has two reports of fungal infections in patients who received NECC steroid shots in the knee, hip, shoulder, or elbow.

Including these cases, 214 people in 15 states got fungal infections traced to NECC products. Fifteen patients have died.

Today’s warning applies only to sterile drugs delivered by injections. “At this time,” the FDA notes, the warning does not include NECC products applied as lotions, creams, eye drops, or suppositories. Before shutting down operations, the NECC offered more than 2,100 different products for sale in all 50 states.

The FDA advises doctors that they may get a lot of calls from patients and to use their judgment about who is at risk.

Symptoms of Fungal Infection, Fungal Meningitis

People who received injections of NECC drugs should be alert for symptoms of fungal infection:

  • Fever
  • Swelling
  • Increasing pain, redness, or warmth at injection site
  • Changes in vision (if injection was in the eye)
  • Pain, redness, or discharge from the eye (if injection was in the eye)
  • Chest pain (if drug was used during heart surgery)
  • Drainage from the surgical site (infection within the chest, if drug was used during heart surgery)

Symptoms of fungal meningitis may be very mild at first. They may include slight weakness, slightly worse pain, or a mild headache. Other symptoms include fever, headache, stiff neck, nausea and vomiting, sensitivity to light, and altered mental status. 

The CDC warns patients who received suspect medications to be alert for:

  • New or worsening headache
  • Fever
  • Sensitivity to light
  • Stiff neck
  • New weakness or numbness in any part of your body
  • Slurred speech
  • Increased pain, redness, or swelling at your injection site

While most patients with infections developed symptoms one to four weeks after infection, the CDC remains unsure how long those who received suspect medications should be on the alert.

The FDA has extended its investigation to include Ameridose, another Massachusetts compounding pharmacy owned by some of the same people who own the NECC. So far, no Ameridose products have been linked to fungal meningitis.

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Covidien Announces FDA 510(k) Clearance And CE Mark For Nellcor™ Bedside Respiratory Patient Monitoring System

Main Category: Medical Devices / Diagnostics
Article Date: 07 Oct 2012 – 0:00 PDT

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Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, has announced U.S. Food and Drug Administration 510(k) clearance and European Economic Area (EEA) CE Mark approval for the Covidien Nellcor™ Bedside Respiratory Patient Monitoring system.

This new system provides continuous monitoring of blood oxygenation (SpO2) and pulse rate, along with trend data to help clinicians detect and respond to dangerous respiratory events sooner. The new Nellcor Bedside Respiratory Patient Monitoring system is upgradable onsite to accommodate new parameters and features, including Nellcor Respiration Rate software, thereby reducing service disruptions and costs for hospitals.

“We are pleased to announce clearance to market the Nellcor Bedside Respiratory Patient Monitoring system in the U.S. and the EEA,” said Robert J. White, President, Respiratory and Monitoring Solutions, Covidien. “With this addition, we now offer an updated portfolio of industry-leading bedside monitoring solutions that meet unique care needs in both high- and low-acuity settings, thus enhancing patient safety in hospitals throughout the world.”

The new system features a color touch-screen graphical user interface and provides a variety of wired and wireless connectivity options to meet the various needs found in different hospital settings. It can connect to the Nellcor OxiNet III Remote Respiratory Monitoring system, enabling clinicians to monitor multiple patients from a central monitoring station on the general care floor.

A SatSeconds alarm management feature helps clinicians differentiate between serious and minor events, reducing clinically insignificant desaturation alarms and alarm fatigue. The monitoring system also features a Saturation Pattern Detection alert for automated, real-time detection of patterns of desaturation that indicate repetitive reductions in airflow.

The device meets current and upcoming standards, including compliance with Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) and ISO 3rd Edition* standards. The new system will be available in the United States and throughout the EEA in the next few months.

Covidien

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7 Oct. 2012. <http://www.medicalnewstoday.com/releases/251204.php>


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Teva’s High-Dose Generic Wellbutrin XLWithdrawn

High-Dose Generic Wellbutrin XL Withdrawn

Oct. 5, 2012 — The FDA has withdrawn its approval of Teva Pharmaceutical’s Budeprion XL 300-mg tablets, a generic version of GSK’s Wellbutrin XL extended-relief antidepressant.

The FDA action comes five years after patients complained of headaches and returning depression after switching from brand-name Wellbutrin XL to Teva’s generic version. The Teva generic was approved in December 2006.

In 2009, the FDA wrongly assured patients that the Teva generic worked just as well as the name brand. But it wasn’t until 2010 that the FDA finally decided to test the full-dose version of the drug. Those tests, completed just weeks ago, found that instead of proper extended release, Teva’s drug dumped too much active ingredient too soon and failed to maintain effective drug levels.

The FDA tests in people finally came to the same conclusion as October 2007 lab tests by Tod Cooperman, MD. Cooperman’s for-profit company, the ConsumerLab web site, tests nutritional supplements and generic drugs for potency and accurate labeling.

“The generic did not act like a once-a-day formula but more like an immediate-release formula,” Cooperman says.

Teva and Impax Laboratories, which makes the drug for Teva, have recalled the drug. The lower-dose version, Budeprion XL 150 mg, remains on the market. FDA’s waived tests of the now-withdrawn 300-mg version of the drug based on tests of the lower-dose version — a process called “waiving up.”

The FDA defended the practice, noting that generic drugs are tested on small numbers of healthy volunteers to see if they work the same as (are “bioequivalent” to) brand-name drugs. The agency was reluctant to expose these volunteers to the side effects of the higher-dose drug.

“A less cautious approach in studying the bioequivalencies of Budeprion XL 300 mg could have brought the data to light earlier,” the FDA admits on its web site.

Alternative Generic Wellbutrin Products

Four other companies make generic, extended-release versions of Wellbutrin XL 300 mg: Anchen, Watson, Actavis, and Mylan.

However, the FDA has asked each of these manufacturers to test the drugs at full dose to see if they truly are the same as the brand-name antidepressant.

It’s likely they are. Most of the complaints received by the FDA concerned the Teva/Impax drug.

Are Generic Drugs Safe and Effective?

Withdrawal of the Teva generic shows that the FDA’s system for ensuring the safety and effectiveness of generic drugs works, says the Generic Pharmaceutical Association (GPhA), the trade group representing generic drugmakers.

“The recall by a single manufacturer of one strength of a generic drug should in no way cast doubt on the impeccable reputation of the generic industry or the FDA in our joint commitment to patient safety,” says Ralph G. Neas, president and CEO of the GPhA.

According to the group, there are more than 10,000 FDA-approved generic drugs in the U.S. Of the 4 billion prescriptions filled in the U.S. each year, almost 80% are for generic drugs.

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What Are Cosmeceuticals?

By Ayren Jackson-Cannady
WebMD Feature

Cosmeceuticals are the marriage of cosmetics and pharmaceuticals. Think: antioxidant plus lipstick or retinol plus face serum.

“Cosmeceuticals will contain active ingredients that are known to be beneficial to humans in some way,” says Marie Jhin, MD, a dermatologist in San Francisco. “For example, vitamin C is a known antioxidant and when this is added to a lotion or cream the product is considered a cosmeceutical.” 

If you read a product’s label and see things like botanical and marine extracts, vitamins, or peptides, it probably could be considered a cosmeceutical.

The FDA doesn’t recognize cosmeceuticals as a separate class of beauty products. It only recognizes three categories: drugs, cosmetics, and soaps. 

“As far as the FDA is concerned, there is no provision for a cosmeceutical. A product is either regulated as a cosmetic or it’s regulated as a drug, and where it falls all depends on the types of claims that are being made,” says cosmetic chemist Jim Hammer.

If a brand launches a product that claims to affect the structure or function of the body, the FDA would consider it to be a new drug and would require clinical trials be done to prove its effectiveness and safety. Assuming that all of the claims from the cosmeceutical product were shown to be true in clinical studies and the product effective, the FDA would approve it — but as a new drug. That’s a pharmaceutical, not a cosmeceutical.

Smart Shopping

If claims are being made (such as “reduces wrinkles” or “eliminates acne“), many times these products have undergone a significant amount of testing to support these claims, from consumer and controlled laboratory tests to stability and preservative efficacy tests.

Still, Jhin says, “The most important thing consumers need to realize is that cosmeceuticals have not undergone rigorous investigation by the FDA, and so you must not take their claims as true or beneficial,” she says. “This is not to say that there isn’t any benefit, but it cannot be substantiated by published scientific studies.”

Do your research before spending your money. If a product’s claims seem too good to be true, they probably are.

“‘Cosmeceuticals’ is a marketing term, not a legal definition,” says Marina Peredo, MD, a Long Island, N.Y., dermatologist. “For most creams, it is not necessary to go through FDA approval.”

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Humira Approved for Ulcerative Colitis Treatment

Sept. 28, 2012 — The FDA has approved Abbott’s Humira for the treatment of moderate to severe ulcerative colitis.

Humira (adalimumab) now is approved for both forms of inflammatory bowel disease (IBD): ulcerative colitis and Crohn’s disease.

It was already approved to treat Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, juvenile idiopathic arthritis, and ankylosing spondylitis.

For ulcerative colitis, Humira is approved when other drugs to suppress immune responses haven’t worked.

“Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual’s needs,” says Donna Griebel, MD, director of the FDA’s gastroenterology division. “Today’s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.”

Clinical studies tested Humira in treating ulcerative colitis patients with moderate to very severe disease. Clinical remission — defined as relatively mild disease — happened after eight weeks of Humira treatment in 16.5% to 18.5% of patients, compared to 9.2% to 9.3% of patients given an inactive placebo.

The FDA-approved dosing regimen for Humira for ulcerative colitis begins with an initial dose of 160 milligrams, a second dose two weeks later of 80 mg, and a maintenance dose of 40 mg every other week, thereafter. The drug is given by injection.

Ulcerative colitis patients who do not get clinical remission after eight weeks of treatment should stop taking Humira.

Common side effects of Humira include infections, reactions at the injection site, headache, and rash.

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