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P T. 2010 September; 35(9): 492–497.
PMCID: PMC2957741

New Drugs/Drug News


Xeomin for Dystonia And Blepharospasm

The FDA has approved incobotulinumtoxinA (Xeomin, Merz) to treat blepharospasm and cervical dystonia. This neurotoxin inhibits the release of acetylcholine, thereby reducing muscle contractions.

A boxed warning mentions the risk of distant spread of the toxin’s effect, which can cause symptoms of botulism such as asthenia, muscle weakness, blurred and double vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and life-threatening swallowing and breathing problems. Caution is advised when Xeomin is used with aminoglycoside antibiotics or other agents that interfere with neuromuscular transmission, such as curare-like compounds.

Xeomin is discussed in this month’s Pharmaceutical Approval Update column on page 526.

Source: Medscape, August 2, 2010

ella Emergency Contraceptive

A new morning-after contraceptive tablet, ulipristal acetate (ella, Watson/Laboratoire HRA Pharma) is now approved. It is effective for up to five days after unprotected sexual intercourse or contraceptive failure. The drug is already sold in Europe as EllaOne.

The only other emergency contraceptive, Plan B, is sold without a prescription for women 17 years of age and older. Plan B contains levonorgestrel, a progestin hormone. Ulipristal is a nonhormonal drug that blocks the effects of hormones necessary for conception. Plan B should be taken as soon as possible after intercourse and may work for up to 72 hours, but it is ineffective after insemination triggers the hormonal surge that leads to ovulation. ella’s effectiveness persists for 120 hours after sexual activity whether or not the hormonal surge has occurred.

Side effects of ella may include headache, nausea, abdominal pain, dysmenorrhea, fatigue, and dizziness. For more information, please see the Pharmaceutical Approval Update column on page 528.

Sources: WebMD, August 13, 2010; Medical News Today, August 14, 2010


Cuvposa Oral Solution Relieves Drooling in Children

Glycopyrrolate oral solution (Cuvposa, Shionogi) has been approved to treat chronic severe drooling caused by neurological disorders (e.g., cerebral palsy) in children 3 to 16 years of age.

Drooling is normal in infants, but developmentally disabled people sometimes experience drooling caused primarily by neuromuscular dysfunction that makes it difficult to swallow. Cuvposa reduces the volume of saliva produced.

Glycopyrrolate was approved several decades ago to treat peptic ulcers and to reduce salivation in patients under anesthesia. Until now, glycopyrrolate was used on an off-label basis in a different dosage form to treat drooling in developmentally disabled patients.

The new flavored solution provides the optimal dose for each patient. Adverse reactions include dry mouth, constipation, flushing, and urinary retention.

Source: FDA, July 29, 2010


Acetaminophen Raises Risk of Asthma and Eczema in Teens

Recent reports have linked acetaminophen use to asthma in children. Studies are now linking acetaminophen to asthma and eczema in adolescents.

Teenagers who used the drug monthly had more than double the risk of asthma compared with teens who did not use it. Yearly use was linked to a 50% increase in asthma risks.

As part of the International Study of Asthma and Allergies in Childhood (ISAAC), questionnaires were given to more than 300,000 13- and 14-year-olds in 113 centers in 50 countries. “Medium” users, who took acetaminophen once in the preceding year, had a 43% higher asthma risk and a 31% higher eczema risk compared with non-users. “High” users, who had used the drug within the previous month, had 2.51 times the risk of asthma and a 99% greater risk of eczema compared with non-users. The risk of rhino conjunctivitis was also 38% higher for medium users and 2.39 times greater for high users than for non-users.

A causal relationship was suggested. It is thought that acetaminophen has a systemic inflammatory effect, which could increase oxygen stress owing to depletion of glutathione-dependent enzymes, resulting in enhanced Th2 allergic immune responses. It is also possible that the drug suppresses the immune response to rhinovirus infections, a common cause of severe asthma in children.

Some investigators believe that acetaminophen use is a factor in the increased incidence of asthma worldwide. In earlier studies, acetaminophen reduced levels of glutathione, an antioxidant found in the lungs. Another study mentions an increased incidence of asthma and wheezing in people taking acetaminophen.

Sources: Am J Respir Crit Care, online, Medical News Today, August 13, 2010;, August 16, 2010

Coumadin Packs Recalled

Bristol-Myers Squibb has voluntarily recalled lots of various blister packs of warfarin (Coumadin) 1-mg tablets. Some of the tablets, over time, might not meet specifications for isopropanol, which is used to maintain the active ingredient (warfarin) in the crystalline state. This discrepancy could affect therapeutic levels of warfarin: too little warfarin can increase the risk of clots, and too much warfarin can increase the risk of bleeding. The recall is precautionary and involves only the 1-mg tablet blister packs distributed in the U.S., not the 1-mg tablets supplied in bottles or any other strengths or dosage forms.

The affected products include:

  • physician sample blister packs (lots 9A48931A, 9A48931B, 9A48931C; expiration date, January 2012)
  • hospital unit-dose blister packs (lots 8F34006B, 8K44272A, 8K46168A, 9F44437A, 9K58012B; expiration dates between June 2011 and November 2012)

Source: FDA, July 14, 2010

Warning: Lamictal And Aseptic Meningitis

The FDA has warned that lamotrigine (Lamictal, GlaxoSmithKline), which is indicated for treating seizures and bipolar disorder, can cause aseptic meningitis. The agency is working with the company to update the prescribing information and the patient medication guide.

A rare but serious side effect of lamotrigine use, aseptic meningitis can also be caused by viruses, toxic agents, some vaccines, and autoimmune disease. Symptoms may include headache, fever, chills, nausea, vomiting, stiff neck, and sensitivity to light.

When meningitis is suspected, lamotrigine should be discontinued if no other cause of meningitis is identified.

The drug was approved in December 2004. Since then and continuing through November 2009, 40 cases of aseptic meningitis have been identified in patients taking the product. Of these 40 patients, 35 needed hospitalization.

Symptoms generally resolved after the drug was discontinued. In 15 cases, even more severe symptoms returned when patients resumed taking the drug.

Source: FDA, August 12, 2010

SSRIs Lack Benefit for Autism

Antidepressants commonly prescribed to people with autistic spectrum disorders should not be recommended at this time, according to a new study. Despite some evidence of benefits in adults with autism, there appears to be no evidence for any benefits associated with selective serotonin reuptake inhibitors (SSRIs) in children, who may experience serious adverse drug effects.

Although SSRIs are widely prescribed, they have not been specifically approved for use in autism. In the U.K., most anti-depressants are not approved for children for any condition. The rationale behind the use of SSRIs in autism is that they act on serotonin, which affects some of the psychological processes affected by the condition.

Cochrane researchers included seven trials of 271 patients in their study. They evaluated fluoxetine (Prozac, Eli Lilly), fluvoxamine (Luvox, Solvay), (Celexa, Forest), and fenfluramine (removed from the U.S. market). Overall, the investigators found no benefit in the five trials in children and did find some evidence of serious harm, including one child who had a prolonged seizure after taking citalopram.

In the two trials for adults, symptoms improved, but there was too little evidence for the drugs to be recommended. A problem with analyzing the results was that each trial used different measures for assessing the drugs’ effects. The researchers said that decisions about using SSRIs for coexisting obsessive-compulsive disorder, aggression, anxiety, or depression in patients with au tism could be made on a case-by-case basis.

Source: Cochrane Database Syst Rev August 8, 2010; Art. No. CD004677

Epoetin alfa Helps In Healing Hip Fractures

Intertrochanteric hip fracture is a threat to older people for a number of reasons, including the danger of blood loss, especially if the patient is anemic. If autologous blood isn’t available, allogenic blood transfusion comes with its own risks for older anemic patients. Researchers from Levadia, Greece have proposed an alternative: epoetin alfa (e.g., Procrit, Ortho-Biotech; Epogen, Amgen).

The authors divided 79 patients with hip fracture into two groups; one group received 10 daily doses of epoetin alfa 20,000 IU beginning from the day of trauma, and the other group received placebo. There was a statistically significant difference between the two groups in the required units of allogenic blood used. Patients receiving epoetin alfa also had higher hematocrit and hemoglobin values, with a statistically significant difference at seven days after surgery, compared with the control group.

The mean follow-up period was 34 months. Three patients were lost to follow-up, although they were doing well at their last examination. Eight patients died of causes not directly related to the hip fracture or to epoetin alfa.

Complications were considered minor. Five patients had a skin inflammatory response or bruising; one patient had chills and fever after the fifth injection. None of the patients had to stop therapy because of adverse effects.

Patients also received 100 mg of parenteral iron each day. Six patients reacted to the iron, but all responded favorably to a reduced infusion.

Epoetin alfa was also cost-effective, according to the researchers. The total cost of therapy was roughly 85% of the cost of preparing and conserving 1 unit of allogenic blood.

Source: J Crit Care 2010;25:348–353

Celebrex Gets Another Look

The results from a recent trial of celecoxib (Celebrex, Pfizer), when compared with omeprazole (Prilosec, AstraZeneca) and diclofenac (Voltaren, Novartis), should prompt a review of current treatment recommendations for patients with arthritis, say researchers from Hong Kong, Spain, Ann Arbor, and Chicago. Although guidelines are based on their own previous work, the study provides data that may help to reduce the risk of therapy with nonsteroidal anti-inflammatory drugs (NSAIDs).

The six-month, double-blind, Pfizer-supported study, CONDOR (Celecoxib versus Omeprazole aNd Diclofenac for at-risk Osteoarthritis and Rheumatoid arthritis patients), enrolled 4,484 patients at 196 centers worldwide. The rate of clinically significant gastrointestinal (GI) events was four times higher in patients receiving diclofenac plus omeprazole than in those receiving celecoxib. As in the earlier trial, rates of upper GI bleeding did not differ among the groups. However, there were large differences for the likelihood of clinically significant blood loss from the GI tract. For patients with substantial decreases in hemoglobin and defined lesions, the data suggested that the upper GI tract was a site of blood loss. Notably, the frequency of upper GI ulcers or erosions associated with hemoglobin reductions was higher with diclofenac/omeprazole than with celecoxib.

Reductions in hemoglobin in the absence of a defined lesion were more than five times more likely with diclofenac/omeprazole than with celecoxib. Celecoxib was also associated with a lower rate of moderate-to-severe abdominal symptoms and withdrawal because of GI adverse events. The small but significant differences contradict results of another meta-analysis suggesting that co-therapy with nonselective NSAIDs plus a proton pump inhibitor was better tolerated than a COX-2 selective NSAID alone, the researchers point out, although they note that the meta-analysis was hampered by a scarcity of head-to-head data.

Source: Lancet 2010;376:373–379

Highly Educated Patients Worry about Drug Safety

In a recent survey of 874 patients who were asked questions about their medications, 20% reported an adverse drug event (ADE). The survey, conducted by researchers from South Dakota State University and University of Iowa, also asked whether respondents had visited a doctor about any ADEs, unwanted reactions, or problems with their medications in the preceding year.

The researchers note that patients may (correctly or incorrectly) assign meaning to their symptoms and have specific interpretations of the cause, results, and ways of controlling symptoms, such as reporting unwanted reactions or side effects to a health care practitioner. Patients with stronger concerns about drug safety might also be more likely to attribute their symptoms to an ADE. However, the respondents in this sample were highly educated, with more access to information about drug risks, compared with the general population, and this may have increased their concerns. They might also have been better able to identify when symptoms resulted from a drug and to readily report them. Patients who had more symptoms were also more likely to report ADEs.

Although nearly half of the respondents received an inappropriate prescription, the study revealed no association between inappropriate medications and self-reported ADEs; that is, patients didn’t know when they were receiving an inappropriate drug and therefore had no reason to link the two. But that’s where paying more attention to the effects of the drugs can help, the researchers suggest: patients who self-report potential ADEs prevent the effects from worsening. This is important when patients are unaware of having received an inappropriate agent.

The researchers suggest that anxious patients with concerns about their medications be helped to reframe negative perceptions of treatment by using cognitive–behavioral interventions.

Source: Am J Geriatr Pharmacother 2010;8:245–257

Ranexa Safely Lowers Glucose Levels

For patients with cardiovascular disease and poorly controlled diabetes, adding the antiangina drug ranolazine (Ranexa, Gilead) to standard treatment may help to lower fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1c) levels without increasing the risk of serious hypoglycemic events.

Researchers assessed results from MERLIN–TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes). Patients (n = 6,560) were randomly assigned to receive either ranolazine or placebo. They returned for study visits at 14 days, then every four months until the end of the study at 16 months. The analysis included 5,244 patients who were assessed at the fourth month.

In addition to its antianginal and anti-ischemic actions, ranolazine had clinically meaningful effects on glucose and HbA1c levels. Reductions were steepest in patients with hyperglycemia. For HbA1c values of 8% to 10%, adding ranolazine reduced HbA1c levels by 1.2%. In patients with FPG levels of 150 to 400 mg/dL, ranolazine use reduced those levels by 25.7 mg/dL.

Although the effects appear small, they were assessed as add-ons to established therapies with dose adjustments of concomitant medications permitted, which is not typical for studies examining glycemia as the primary endpoint.

Ranolazine was not associated with increased rates of severe hypoglycemia; this agent has established cardiovascular safety in patients with acute coronary syndrome, a particularly vulnerable population that has been inadequately investigated during early development of diabetes-specific therapies.

Source: Diabetes Care 2010;33:1163–1168

Pain and Non-Pain Treatment In Palliative-Care Patients

Pain isn’t the only problem facing patients in nursing-home and hospice settings. A study of 303 patients found that although the reported prevalence of non-pain symptoms was low, more than half of the patients had non-pain symptoms that were undertreated. The researchers, from the Veterans Affairs Health System and the University of Pittsburgh School of Medicine, say that to the best of their knowledge, this is the first national study to examine the pharmacological undertreatment of non-pain symptoms in palliative-care patients.

In the study, 82 patients had one or more non-pain problems: constipation with fecal impaction, cough, nausea and vomiting, fever, and diarrhea. Of those 82 patients, 47 were undertreated. The undertreated patients also had more problems with mobility, mood, and pressure ulcers. Moreover, they had more secondary diagnoses but, interestingly, a shorter length of stay.

Although medication intake generally increases with age, the underuse of medications or the omission of drug therapy that is indicated for the treatment or prevention is also important. They authors acknowledge that debilitated patients do not always communicate their symptoms, or the staff might have misperceptions about the patient’s degree of discomfort. Patients with depressive symptoms may also be less likely to report non-pain symptoms or to request medications. As for the shorter length of stay, it’s possible that patients who stay longer simply get more treatment.

Source: Am J Geriatr Pharmacother 2010;8:225–232

Drug Shortages Persist

Shortages of critically important medications can compromise or delay drug therapy, causing medication errors. Health care practitioners are very concerned about how frequently these shortages are adversely affecting patient care. For example, various formulations of hydromorphone (e.g., Palladone, Dilaudid), propofol (Diprivan), and epinephrine have recently been in short supply.

The number of shortages experienced in the past few months is unprecedented, particularly with high-use emergency, pain, and anesthetic agents. Health care providers have been experiencing frequent stock depletion of critical drugs, often without notice. Even when an acceptable alternative is found, it might be available in a different dosage strength or might need to be prepared differently, thus adding to the complexity of care and increasing the risk of errors.

Drug companies do not have to disclose the cause of a shortage or to notify the FDA when it stops production unless it is the sole provider of the agent and unless it is deemed a medically necessary product. Causes of shortages include a lack of materials; delays in production; voluntary recalls; a change in formulation (e.g., inhalers without chlorofluorocarbons); availability of generic products, thus halting production of brand-name drugs; patent expiration; company mergers; discontinuation of a product; moving production to a new facility; poor inventory-ordering practices; stockpiling before price a increase or hoarding caused by rumors of an impending shortage; unexpected increases in demand when a new indication is approved; new therapeutic guidelines; disease outbreaks; and natural disasters.

Sources: ISMP Newsletter, July 29, 2010; Am J Health Syst Pharm 2009;66:1399–1406.

HAART Reduces HIV Infection in Drug Users

Highly active antiretroviral therapy (HAART), known for its benefits against HIV infection, also reduces the spread of the virus among people with a history of injection drug use, according to the National Institutes of Health (NIH).

HAART combines drugs that target the virus at different points in its life cycle. Although not a cure, HAART stops the virus from replicating, stops disease progression, and prolongs survival. In a Canadian study, increasing levels of HAART coverage were associated with decreases in viral load and with fewer new HIV diagnoses.

Previous research had suggested that increased HAART coverage reduced the spread of HIV in the general population. The new findings apply not only to the general population but also to individuals with a history of injection drug use. These findings are important because the number of new HIV cases has remained steady in the U.S. (about 56,000 per year for the past 10 years).

Worldwide, 2.7 million new HIV infections were diagnosed in 2008. In the U.S, more than 1 million people live with diagnosed or undiagnosed HIV/AIDS.

Sources: Lancet online, July 18, 2010; NIH

Healthy Heart, Younger Brain

A healthy heart may help in delaying aging of the brain. In a new observational study, people whose hearts pumped less blood had brains that appeared older than the brains of those whose hearts pumped more blood. A decreased cardiac index was associated with smaller brain volume. The link was present even in subjects without cardiovascular disease.

As the brain ages, it begins to atrophy, and the decrease in brain volume is considered a sign of brain aging. More severe brain atrophy occurs in those with dementia, such as Alzheimer’s disease.

Researchers evaluated 1,504 participants (34 to 84 years of age, 54% women) in the Framingham Offspring Cohort who did not have a history of stroke, transient ischemic attack, or dementia. They assessed cardiac output, adjusted the data for each participant’s body surface area, and measured brain volume using magnetic resonance imaging (MRI).

Participants with the least amount of blood pumping from the heart for their body size showed almost two more years of brain aging than people with the highest cardiac index. Participants with low but normal levels of blood pumping from the heart also showed almost two more years of brain aging than those with the highest cardiac index. The researchers were surprised to find that this low-normal group also had smaller brain volumes than people with a healthy cardiac index. Because only 7% of the subjects had heart disease, the researchers did not expect 30% of participants to have a low cardiac index.

In the study, patients with smaller brain volumes did not show obvious signs of diminished brain function. Cardiac index was related to structural brain changes but not to cognitive changes; however, structural changes suggested that something might be wrong. A lower amount of blood pumping from the heart might reduce blood flow to the brain, providing less oxygen and fewer nutrients needed for brain cells.

Sources: Circulation, American Heart Association, August 2, 2010; Science Daily, August 3, 2010

Chinese Herb Extract May Help Control Diabetes

Emodin, a natural product that can be extracted from Chinese herbs, including Rheum palmatum and Polygonum cuspidatum, shows promise as an agent that could reduce the impact of type-2 diabetes. Giving emodin to mice with diet-induced obesity lowered body weight, reduced central fat mass, decreased blood glucose and serum insulin levels, improved insulin resistance, and improved serum lipids. The study was conducted in Shanghai, China.

Emodin is a potent selective inhibitor of 11β-HSD1, an enzyme that might have a role in the metabolism of dietary sugar.

Source: Br J Pharmacol 2010;161:113–126.


New Coating Kills MRSA

Researchers at Rensselaer Polytechnic Institute have created a nanoscale coating for surgical equipment, hospital walls, and other surfaces that can eradicate methicillin-resistant Staphylococcus aureus (MRSA), the bacterium responsible for antibiotic-resistant infections.

The coating’s surface contains an enzyme that is safe to handle, doesn’t seem to lead to resistance, doesn’t leach into the environment, and doesn’t become clogged with cell debris. When MRSA bacteria come in contact with the surface, they are destroyed. In tests, 100% of MRSA organisms in solution were killed within 20 minutes of contact when a surface painted with latex paint was laced with the coating.

Carbon nanotubes are united with lysostaphin, a naturally occurring enzyme used by nonpathogenic strains of staphylococci to defend against S. aureus, including MRSA. The resulting conjugate can be mixed with several surface finishes. In tests, it was mixed with ordinary latex house paint.

The nanotube–enzyme coating is toxic only to MRSA. It can be washed repeatedly without losing effectiveness. The coating has a dry storage shelf life of up to six months.

The product is a result of several years of previous work in which enzymes were embedded into polymers. In earlier studies, enzymes that were attached to carbon nanotubes were more stable and more densely packed when embedded into polymers than enzymes alone. The scientists wanted to create a stabilizing environment, and the nanotubes allowed them to do that.

They focused on lysostaphin, an enzyme secreted by nonpathogenic staphylococcal strains. This enzyme is harmless to humans and other organisms, but it is capable of killing S. aureus, including MRSA. It is commercially available. When a tiny amount of lysostaphin was put in a solution with S. aureus, the bacteria died almost immediately.

Lysostaphin first attaches itself to the bacterial cell wall, then slices it open. The enzyme does not work against other bacteria. It is attached to the carbon nanotube with a short flexible polymer link, which improves its ability to reach the MRSA bacteria.

The more the lysostaphin can move around, the better it works. The team successfully tested the resulting nanotube–enzyme conjugate. This approach is likely to prove superior to previous coatings that either released biocides or speared the bacteria. Coatings that release biocides can be harmful and lose their effectiveness over time as their active ingredient leaches into the environment. Coatings that spear bacteria tend to clog, also losing effectiveness. The new coating does neither. During testing, the enzyme remained embedded near the surface of the paint.

MRSA are unlikely to develop resistance to a naturally occurring enzyme. Lysostaphin has evolved over millions of years to be very difficult for S. aureus to resist.

Sources: ACS Nano, July 2010; R&D Magazine, August 17, 2010



Introducers. The FDA has issued a class I recall of St. Jude Medical 6 French Engage Introducer devices because its shaft or hub assembly could break and cause potentially life-threatening bleeding. The device is used to implant catheters and electrodes into blood vessels and helps to prevent blood loss. The company issued an urgent recall notice on June 24 warning of the hazard. The recall affects more than 5,100 devices made between April 27 and June 3, 2010. The following devices are affected:

  • 7-cm length, 0.025-inch Max Guide Wire (No. 3109782)
  • 12-cm length, 0.025-inch Max Guide Wire (No. 3105838)
  • 25-cm length, 0.035-inch Max Guide Wire (No. 3107645)
  • 12-cm length, 0.035-inch Max Guide Wire (Nos. 3103891, 3110889, 3118794, 3123051)
  • 12-cm length, 0.038-inch Max Guide Wire (Nos. 3107789, 3107790)

Sources: FDA, MedPage Today, August 15, 2010

Baxter Colleague Pumps. Federal regulators have published final requirements for a recall of Colleague Volumetric Infusion Pumps. Baxter International, Inc., had issued the recall this past May. The FDA ordered the recall because of 56,000 complaints of injuries, deaths, and malfunctions submitted from 2005 to 2009.

Infusion pumps deliver fluids, nutrients, and medications into a patient’s body in a controlled manner. They are used in the hospital and, increasingly, in the home because they allow a greater level of accuracy in fluid delivery.

According to an FDA press release issued in May, the order to recall the pumps was based on Baxter’s longstanding failure to correct serious problems such as battery malfunctions and software errors.

The recall involves as many as 200,000 pumps. Baxter will provide a guide to assist customers affected by the recall. The guide will include a list of FDA-approved pump alternatives and suggestions on how to minimize disruption and risks during the transition period.

Baxter will continue to provide batteries, spare parts, and service during the transition period for customers who submit a Certificate of Medical Necessity to Baxter. The certificate, provided by Baxter, asks for the number of pumps currently in use, serial numbers, and the anticipated date on which the pumps will be removed from use. After receiving the completed certificate, Baxter will continue service for 24 months from June 14, 2010, or until the customer has switched to another pump. The company must complete the recall, replace pumps, and grant refunds by July 14, 2012.

The FDA had been working with Baxter since 1999 to correct numerous flaws. Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power-off, and data errors. In June 2006, the FDA obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the pump until it brought the devices into compliance. Since then, Baxter has made many changes to the pumps but has not corrected the product defect leading to the permanent injunction.

The present recall order was issued after Baxter proposed a plan that would not have addressed problems with the pump until 2013. The FDA called the plan unacceptable because it left potentially dangerous pumps on the market for another three years.

Sources: FDA, July 15, 2010;

Stricter Criteria For Device Approvals

The FDA has released recommendations designed to improve oversight of the medical device industry. Makers of x-ray machines, drug pumps, and other devices in the U.S. would have to submit more safety data to win federal approval.

For almost 35 years, the FDA has used the 510(k) system to grant speedy approval to devices that are deemed similar to products already on the market. This system is popular among manufacturers because it is a faster, cheaper path to market than the review process for novel devices, which must undergo more rigorous testing. About 4,000 devices are approved each year under the 510(k) system, and about 50 devices are approved under the more stringent system. However, high-risk devices (e.g., pacemakers) may be slipping through the 510(k) process without thorough testing.

The FDA’s panel recommends that the agency clarify when a device is similar enough to those already approved to receive 510(k) clearance and that manufacturers submit all available safety data about their device instead of just basic information now required. The FDA says that it might make it easier to revoke approved devices on the market that appear unsafe or ineffective. Approvals have been rescinded for approximately 100 510(k) devices since 1976.

Sources: FDA, August 4, 2010; Associated Press, August 3, 2010

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