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P T. 2011;36(11): 705-708, 710-712

New Drugs/Drug News/New Medical Devices November 2011


Ferriprox Reduces Excess Iron

Deferiprone (Ferriprox, Apo-Pharma, Inc.) has been approved to treat iron overload resulting from blood transfusions in patients with thalassemia who have responded inadequately to previous chelation therapy. Thalassemia is a genetic blood disorder that causes anemia.

Patients with thalassemia have excess iron levels from frequent blood transfusions, a serious and potentially fatal condition. They may also be at risk for liver disease, diabetes, arthritis, heart failure, and arrhythmias.

The standard therapy for transfusional iron overload is chelation. Deferiprone is intended for use when chelation therapy has been inadequate. It represents the first new FDA-approved treatment for iron overload since 2005. The therapy was approved under the FDA’s accelerated approval program. Apo-Pharma plans to study the use of deferiprone in patients with sickle cell disease.

Source: FDA, October 14, 2011

Juvisync for Diabetes And Cholesterol

The FDA has granted approval to Merck, Sharpe & Dohme for Juvisync, a fixed-dose combination tablet containing two drugs, also made by Merck, sitagliptin (Januvia) and simvastatin (Zocor).

Sitagliptin helps to lower blood glucose levels, and it is approved for use in combination with diet and exercise to improve glycemic control in adults with type-2 diabetes. Simvastatin is approved for use with diet and exercise to reduce serum levels of low-density lipoprotein-cholesterol (LDL-C).

Juvisync is indicated only when a person needs both drugs. It is available as sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg. The company plans to develop tablets with the sitagliptin 50 mg-dose as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. Patients who require the 50-mg sitagliptin dose should continue to use the single-ingredient sitagliptin tablet.

Simvastatin is sold in strengths of 5, 10, 20, 40, and 80 mg. As a result of restrictions placed on the use of the 80-mg dose because of a risk of muscle toxicity, an 80-mg dose will not be available in the combination. There is no plan to develop a fixed-dose combination tablet with simvastatin 5 mg, a rarely used low dose.

Juvisync was approved with a patient medication guide.

Source: FDA, October 7, 2011

Onfi Tablets for Severe Seizures

Clobazam (Onfi, Lundbeck/Catalant) has been approved as an orphan drug for use as add-on therapy for seizures associated with Lennox–Gastaut syndrome in adults and children 2 years of age and older.

A medication guide is being required for patients and their caregivers.

Source: FDA, October 24, 2011

Bupivacaine HCl Injectable Anesthetic

Sagent Pharmaceuticals, Inc., has announced the FDA’s approval of bupivacaine HCl injection, USP. The medication is used for regional and local anesthesia or analgesia in general, oral, and dental surgery; diagnostic and therapeutic procedures; and obstetrics.

The product will be available in six single-dose and two multidose latex-free vials. Bupivacaine is the 13th product approved under a joint venture between Sagent and Strides Arcolab.

Sources: Globe Newswire, October 20, 2011;;

Generic Olanzapine For Psychiatric Disorders

The first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) have been approved to treat schizophrenia and bipolar disorder. Dr. Reddy’s Laboratories and Teva will be manufacturing the generic tablets, and Apotex Inc., Dr. Reddy’s Laboratories, and Par Pharmaceuticals will be manufacturing the orally disintegrating tablets.

Olanzapine must be dispensed with a medication guide. A boxed warning mentions that this type of drug can raise the risk of death in elderly people with psychosis caused by dementia. Olanzapine is not approved for treating psychosis in elderly patients with dementia.

Source: FDA, October 24, 2011


Cialis for Benign Prostatic Hyperplasia

Tadalafil (Cialis, Eli Lilly) has been approved to treat the signs and symptoms of benign prostatic hyperplasia (BPH) as well as BPH and erectile dysfunction (ED) when these conditions occur simultaneously. Tadalafil was approved in 2003 for the treatment of ED.

This drug should not be used if the patient is taking nitrates (e.g., nitroglycerin), and it should not be combined with alpha blockers, which can cause a severe decrease in blood pressure.

Source: FDA, October 6, 2011

Add-on Therapy: Byetta and Insulin Glargine for Diabetes

Exenatide injection (Byetta, Eli Lilly/Amylin) is now approved as an add-on therapy to insulin glargine (Lantus, Sanofi), a long-acting insulin, with or without metformin or a thiazolidinedione (TZD). The combination is to be used in conjunction with diet and exercise for adults with type-2 diabetes who are not achieving adequate glycemic control with insulin glargine alone.

Exenatide, approved in 2005, stimulates the pancreas cells to produce insulin. The fixed-dose regimen is expected to improve blood glucose control after meals and at other times.

Sources: Ann Intern Med 2011;154: 103–112; Eli Lilly/Amylin, Bloomberg Business News, October 19, 2011


Gralise for Post-Shingles Pain

Gabapentin tablets (Gralise, Depomed) have been approved as a once-daily treatment for postherpetic neuralgia (PHN). The drug is sold in a 30-day starter pack, which allows titration of the drug to full dose in 15 days. It is also available as 600-mg and 300-mg tablets. Polymer technology is used to enable the gradual release of the drug.

There is no branded or generic equivalent. Gralise is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

Source: Depomed, Inc., October 10, 2011,,

Fluoxetine 60 mg in One Tablet

A New Drug Application (NDA), submitted by Edgemont Pharmaceuticals, LLC, has been approved for 60-mg fluoxetine tablets. Originally sold in the U.S. as Prozac (Eli Lilly), fluoxetine is used to treat major depressive disorder, obsessive compulsive disorder in adults and children, and bulimia nervosa and panic disorder in adults.

This is the only fluoxetine product to offer a 60-mg dose in a single tablet. The tablets can also be cut in half to allow a convenient 30-mg dosing option. Before the approval, patients needing 30 mg or 60 mg had to take three 10-mg pills or three 20-mg tablets. By reducing the number of tablets per dose from three tablets to one, the company hopes for improved patient compliance.

Source:, October 11, 2011

Smaller, Lower-Dose Androderm Patch

Watson’s Androderm patch (testosterone transdermal system) is now available in 2-mg and 4-mg formulations. The new smaller size and lower-dose patch provides effective testosterone administration with a 20% reduction in the active ingredient from the original strength.

Androderm is indicated for men with conditions associated with a deficiency or absence of endogenous testosterone.

Source: Watson, October 21, 2011


VA and Others To Stop Using Avastin

The Department of Veterans Affairs (VA) plans to stop using bevacizumab (Avastin, Genentech/Roche) to treat wet age-related macular degeneration (AMD) because of reports of serious infections and blindness.

Bevacizumab, which prevents blood-vessel growth, is approved to treat some cancers. It costs about $50 per dose, compared with $2,000 for Genentech’s ranibizumab (Lucentis), which is approved for wet AMD and macular edema following retinal vein occlusion.

When the VA’s investigation is complete, the agency will reassess how bevacizumab and similar therapies might be made available for ophthalmologic use. In August, the FDA had linked at least 12 serious eye infections in the Miami, Florida, area to repackaged bevacizumab. Some of the cases resulted in blindness.

In related news, Blue Shield of California announced that it would soon stop paying for the use of bevacizumab as a therapy for breast cancer.

Sources: Bloomberg News, September 22, 2011; The Wall Street Journal, October 3, 2011

Xigris Removed From Market

Results from a new study of drotrecogin alfa (activated) (Xigris), used to treat patients with septic shock, have prompted Eli Lilly to withdraw the drug from all markets. All ongoing infusions of the drug should be discontinued, and new infusions should not be started.

Xigris increased the risk of serious bleeding in earlier studies, even though no significant higher risk was found in the most recent study, called PROWESS–SHOCK. However, the drug was not found to improve survival; thus, its benefit–risk profile and its continued use were called into question.

The treatment had been considered a strategy to reduce the incidence of death in high-risk adults with severe sepsis.

Source: American Society of Health-System Pharmacists, October 25, 2011

Aspirin and Vision Loss

Taking one aspirin per day may increase the chances of acquiring the severe form of wet age-related macular degeneration (AMD) after age 65, according to new research. Aspirin has many health benefits, including reduced risk of heart attack and colon cancer, but it has recently been associated with vision problems.

Dutch researchers analyzed aspirin use and macular degeneration in 4,691 subjects enrolled in a European eye study from 2000 to 2003; 41% of participants used aspirin and 59% did not.

Daily aspirin users had more than twice the risk of developing wet AMD than non-users. Weekly aspirin use increased the risk of wet AMD by 41%, but no risk was linked to monthly use. Daily aspirin use also increased the risk of early AMD, but not mid-stage AMD; it was not associated with the dry form of AMD.

The data did not prove that aspirin causes vision loss, but the findings are of concern if aspirin exacerbates the eye disorder, given that many older people take it daily for heart disease. For people with AMD, it might be wise to avoid aspirin.

Sources: Ophthalmology, September 14, 2011, online; WebMD, October 3, 2011

Diabetes and Colon Cancer

Diabetic patients may have an increased risk of colon cancer. Researchers at the University of California, Berkeley, combining the results of 14 international studies, found that, overall, people with diabetes were 38% more likely to develop colon cancer than those who did not have diabetes. There was also a 20% increase in the risk of rectal cancer, although the risk appeared to be limited to men.

The analysis included studies published from the 1990s through 2009, from the U.S., Canada, Europe, and Japan. The findings did not prove that diabetes directly contributed to colon cancer.

One theory is that hormones might be involved. People with diabetes tend to have high levels of insulin and insulin-like growth factors. Those hormones cause cells, perhaps including cancer cells, to grow and spread.

So far, diabetic patients have not been advised to undergo colon cancer screening more often, or at a younger age, than people without diabetes, and diabetes is not currently considered to be a risk factor.

In 2010, the American Cancer Society found that among 184,000 older people who had been observed for 15 years, men with type-2 diabetes were about 25% more likely to have colon cancer than men who did not have diabetes. Yet that increase in risk was modest and smaller than previous studies had suggested. No similar increase was noted in women with type-2 diabetes.

The findings might reflect better diabetes control among residents in the U.S. and among women in recent years.

Source: Am J Gastroenterol, October 3, 2011

Smoking and Responses to Plavix

Although patients with heart disease are advised not to smoke, the good news is that smoking status does not seem to affect platelet function in patients who are using clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi) or prasugrel (Effient, Eli Lilly), according to a study from the U.S. and Germany.

Age, sex, diabetes, and body mass index have been consistently associated with altered platelet responses to clopidogrel. However, only 10% to 22% of low responses to clopidogrel are explained by genetic, demographic, and clinical variables.

Earlier studies also showed conflicting results on whether smoking changed clopidogrel’s effects. Cytochrome P450 (CYP) 1A2 is one of the enzymes involved in the metabolism of clopidogrel. In an experimental study, smoking was associated with a dose-dependent increase in CYP1A2 function and 1.7-fold higher enzyme activity in subjects smoking more than 20 cigarettes per day. Therefore, smoking might have an impact on the antiplatelet response to clopidogrel.

The researchers analyzed platelet function in 4,819 patients from several cohorts undergoing percutaneous coronary intervention (PCI). They also analyzed the potential interaction of smoking with the clinical effect of clopidogrel, compared with prasugrel, in 13,608 patients in the TRITON-TIMI 38 study. The proportion of active smokers ranged between 10% and 20%. No significant differences were found in platelet aggregation between smokers and nonsmokers who received loading and maintenance doses of clopidogrel (75 mg and 150 mg, respectively). Only in the small group of 16 smokers receiving prasugrel was there a significant trend for higher platelet aggregation (i.e., less inhibition) with more cigarettes smoked.

To find out whether smoking affected platelet function after smoking cessation, patients were grouped according to current and former smoking status. In the Effect of Clopidogrel Loading and Risk of PCI (EXCELSIOR) study, mean platelet aggregation (5 micromol/L of adenosine diphosphate) one day after PCI was 8% in nonsmokers, 8% in current smokers, and 9% in former smokers. The proportions of patients with a low response to clopidogrel were 28% for nonsmokers, 24% for current smokers, and 31% for former smokers.

Source: Am Heart J 2011;162:518–526.e5

Statins Plus Antiplatelets For Venous Thromboembolism

As evidence grows to support the theory of a possible common inflammatory mechanism for venous thromboembolism (VTE) and atherosclerotic disease, researchers from two hospitals in Philadelphia decided to determine whether combining statins and antiplatelet therapy could help prevent VTE. They conducted a retrospective study of 1,100 patients with atherosclerosis, including ischemic stroke and myocardial infarction. Patients taking oral anticoagulants were excluded.

Over the 5-year study period, VTE developed in 107 patients (9.7%). The results reinforced the notion that the well-known risk factors (i.e., metastatic cancer, immobilization, hormone use, and obesity) statistically increased the risk of developing VTE. Similarly, the data supported statin use, both alone and in combination with antiplatelet therapy.

Among the statin users, 6.3% (54/861) developed VTE, compared with 22% (53/239) of those not using statins. After controlling for confounding factors, statin use was still associated with a lower risk of VTE. High doses of statins (an average of 50.9 mg/day) lowered the risk of VTE compared with standard doses (an average of 22.2 mg/day).

Although antiplatelet therapy in VTE prevention is controversial, both aspirin and clopidogrel showed benefits in this study. Moreover, dual-antiplatelet therapy resulted in better outcomes than did single-antiplatelet therapy.

The highest protective effect was seen when statins were combined with anti-platelet agents, which further reduced the occurrence of VTE (hazard ratio, 0.16).

The researchers considered it possible that combination treatment reduces platelet thromboxane A1 in the platelet-aggregation process, which may play a role in arterial and venous thrombosis.

Source: Am J Med 2011;124:852–859

Racial Disparities And Medication Problems

Although many older adults have problems with their medications, such as undertreatment and underdosing, African-Americans have more problems than Caucasians.

In a prospective study from North Carolina that involved in-home interviews and medical record reviews of 100 African-Americans and 100 Caucasians, researchers assessed the prevalence, number, and type of problems at baseline, 6 months, and 12 months. Drug-related problems were both prevalent and persistent, and over that time period, they actually increased.

Most participants were women. Caucasians were significantly older, had more education, and were more likely to live alone. They also used more drugs, had more chronic conditions, and visited physicians more often. African-Americans were less likely to buy medications because of the cost.

Although all patients were in primary care and were receiving standard of care, all had at least one medication-related problem at each time point—most commonly, undertreatment, suboptimal drug use, suboptimal dosing, nonadherence, and the unavailability of a less costly alternative drug.

The prevalence of the unavailability of a less expensive drug differed significantly between African-Americans (49%) and Caucasians (46%) at baseline after adjusting for a fixed pharmacist effect; the baseline number of drugs; age; sex; and health literacy. There was also a significant difference in the prevalence of nonadherence at baseline; moreover, rates of nonadherence increased slightly over the 12 months (from 68% to 71% for African-Americans and from 42% to 48% for Caucasian patients).

Suboptimal drug use also increased over time, notably among Caucasians. When nonadherence was removed from the model, more problems remained for African-American patients than for Caucasian patients at baseline (4.34 vs. 3.97), suggesting that other disparities in the quality of medication use do exist.

Source: Am J Geriatr Pharmacother 2011;9:250–258

Antibacterials and Hyperkalemia

In a study of patients in several Canadian databases, 11% of patients receiving spironolactone (e.g., Aldactone, Pfizer) were also given at least one prescription for trimethoprim–sulfamethoxazole (TMP–SMX; Bactrim, Septra), putting them at a high risk for being hospitalized with hyperkalemia—in fact, more than 12 times higher.

In the study, conducted by researchers from Canada and Saudi Arabia, 165,754 patients who were treated with spironolactone were identified during an 18-year study period. Of these patients, 17,859 were given TMP–SMX. Of the spironolactone patients, 6,903 were admitted for hyperkalemia, and 306 of them were admitted within 14 days of receiving TMP–SMX, amoxicillin (Amoxil, Glaxo-SmithKline), norfloxacin (Noroxin, Merck), or nitrofurantoin (e.g., Furadantin, Norwich/Shionogi).

After multivariate adjustments, hospitalized patients were more than 12 times as likely to have received a recent prescription for TMP–SMX than for amoxicillin. The researchers observed no association between hyperkalemia and norfloxacin; nitrofurantoin was associated with a less pronounced increase in risk. The risk was higher with the double-strength formulation of TMP–SMX, compared with the single-strength tablets.

The data suggested that approximately 60% of all cases of hyperkalemia in older patients taking spironolactone and treated with an antibiotic for a urinary tract infection could be avoided if TMP–SMX were not prescribed.

This is the first estimate of the risk of coprescribing TMP–SMX and spironolactone. Serious hyperkalemia can cause sudden death and is the most dangerous complication of treatment with spironolactone.

Hyperkalemia develops in as many as one-third of patients receiving spironolactone, underscoring the need to choose alternatives to TMP–SMX or to closely monitor patients who are receiving both drugs.

Source: BMJ, 2011;343:d5228

Tysabri Decreases Remitting MS Episodes

Taking the anti-inflammatory drug natalizumab (Tysabri, Elan/Biogen Idec) for two years was found to reduce the number of patients with remitting multiple sclerosis (MS) who experience relapses and progression of disability.

Many patients with MS feel healthy for a while, then relapse into periods of ill health. Over time, the disease tends to develop into a permanent disability. The aim of treatment is to increase the period of remission between relapses and to delay the progression to the full disease for as long as possible.

Natalizumab prevents some white blood cells from passing from blood vessels into the brain. Because MS is linked to inflammation, the theory is that blocking this passage of cells might help reduce the symptoms.

A team of researchers in Italy and the United Kingdom identified three trials showing that natalizumab reduced the risk of experiencing at least one new bout of disease at 2 years by about 40%. The number of patients who had disability progression over the 2 years was reduced by 25%. However, progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain disease caused by the John Cunningham virus (JCV), developed in two patients in the trials.

Because of the safety concerns and the high cost of natalizumab, further research is needed to pinpoint which patients might benefit the most from the therapy.

Source: Cochrane Database Syst Rev, Issue 10, October 5, 2011

Dialysis Three Times Weekly Might Not Be Enough

Findings from a major study are challenging the wisdom of the way diabetic patients and those with failing kidneys have been treated for the past 50 years. Apparently, three-times-weekly dialysis is not adequate. Deaths, heart attacks, and hospitalizations were much higher on the day after the two-day interval between treatments each week than at other times, the study found.

Most of the 400,000 Americans with renal failure must undergo blood purification three days a week at dialysis clinics, usually on Mondays, Wednesdays, and Fridays or on Tuesdays, Thursdays, and Saturdays, with a two-day break between the last session of the week and the next one.

The three-day dialysis schedule has been customary since the mid-1960s. However, doctors now think that the two-day hiatus between treatments might be risky. Some studies have reported more heart-related deaths on the day after the gap, with fluid and toxin buildup most prominent on Monday mornings right before dialysis.

The latest research, funded by the National Institutes of Health, analyzed the medical records of 32,000 people who had dialysis three times a week from 2005 through 2008. The average age was 62, and 25% of the patients had been on dialysis for a period of one year or less. After about two years of follow-up, 41% had died, including 17% from heart-related causes.

There was a 22% higher risk of death on the day after a long break than on other days of the week. However, changing the schedule could be difficult for patients, dialysis centers, and insurers.

Source: N Engl J Med 2011; 365:1099–1107; Denver Post, Associated Press, September 22, 2011

Are Drugs Better Than Stents In Preventing Stroke?

Inserting a stent into the brain to improve blood flow to prevent a second stroke might be doing more harm than prescribing cholesterol-lowering drugs and lifestyle changes. In a new study, patients receiving a brain stent had more than twice the rate of strokes and deaths one month after surgery than patients treated with drugs alone. An ongoing trial involving the addition of Stryker Corp.’s Wingspan stent to medications was halted early.

The self-expanding device is the only system approved by the FDA for certain high-risk stroke patients. Other similar devices that are not approved by the FDA for these patients are being used as well.

Researchers studied 451 patients in 50 medical centers who had recently had a stroke or stroke-like symptoms caused by narrowing of a major brain artery. Each patient was given blood-thinning drugs and treatments to lower blood pressure (BP) and cholesterol. Half of the patients also received stents. The researchers had expected the stenting system to cut the risk of stroke or death by 35% over two years. Instead, 14.7% of stent patients had a stroke or died within the first 30 days of enrollment, compared with 5.8% of patients who received drugs and lifestyle advice alone.

The increased risk from stents appeared to extend beyond the first month of treatment. During a nearly one-year follow-up period that began after the first 30 days of the trial, 20.5% of patients in the stent group and 11.5% of patients in the drugs-and-lifestyle group had a stroke or died. An independent safety board then recommended that researchers stop enrolling new patients. Everyone already in the trial will be followed for two years to study the long-term effects of both treatment approaches.

Dr. Marc Chimowitz said that stroke patients with recent symptoms and an intracranial arterial blockage of 70% or greater should receive only aggressive medical therapy that follows the regimen used in this trial as closely as possible. Some researchers still think there could be a place for stents.

Sources: N Engl J Med 2011;365(11): 993–1003;, September 8, 2011; Bloomberg, August 13, 2011


Reducing Cholesterol To Treat Brain Cancer

Glioblastoma, a lethal brain cancer, may some day be able to be treated with cholesterol-lowering drugs. In a study from the University of California, Los Angeles, EGFR vIII, an oncogene in glioblastoma, increased the activity of the receptor for low-density lipoprotein (LDL) and therefore allowed for large amounts of cholesterol.

Glioblastoma cells apparently need cholesterol to grow and survive. Cholesterol has a role in making new membranes, and rapidly growing tumors need many membranes.

Research is focusing on combatting a tumor’s growth supply rather than the tumor itself, such as with the use of bevacizumab (Avastin, Genentech, Roche). If the work can be confirmed in larger studies, it could lead to a role for cholesterol-manipulating drugs.

Sources: Cancer Discovery, September 15, 2011; Medscape Today, September 16, 2011


New Approval: LeGoo Gel For Vascular Surgery

PuraMed’s LeGoo has been approved to temporarily stop blood flow in blood vessels below the neck that are 4 mm or less in diameter during surgery. The device enables surgeons to join blood vessels without clamps or elastic loops, and stopping the blood flow enables surgeons to visualize where to place sutures to connect the vessels. LeGoo minimizes blood without damaging blood vessels.

The nontoxic gel is liquid at room temperature and solid at higher temperatures. When injected into a blood vessel, the gel forms a plug that molds to the shape of the vessel and stops blood flow for up to 15 minutes. After the blood vessels are joined, the plug dissolves on its own in 15 minutes. LeGoo is contraindicated for use in vessels that supply blood to the brain.

Source: FDA, October 5, 2011

Inhalers With CFCs To Be Discontinued in 2012

Epinephrine inhalers containing chlorofluorocarbons (CFCs) will not be made or sold after December 31, 2011. These devices (such as Primatene Mist, Armstrong) are the only FDA-approved inhalers for the temporary relief of occasional symptoms of mild asthma that are sold without a prescription. CFCs are used to propel the medication out of the inhaler to be breathed in by the lungs. The devices will be unavailable because of the Montreal Protocol on Substances that Deplete the Ozone Layer, an agreement that was signed by the U.S.

Many manufacturers have replaced CFCs with an environmentally friendly propellant, hydrofluoroalkane (HFA). There is currently no HFA version of epinephrine inhalers. Many safe inhalers are available with a prescription. Primatene Mist now carries a notice about the phase-out date on its product label.

Source: FDA, September 22, 2011


Marvin M. Goldenberg, PhD, RPh, MS

Name: Sonolith i-move Device

Manufacturer: EDAP TMS SA, Lyon, France

Approval Date: August 3, 2011

Purpose: The Sonolith i-move device is used in breaking up kidney stones, extracorporeal shock wave lithotripsy procedures, and endourology applications.

Description: This compact, mobile lithotripter replaces the Sonolith Praktis. An infrared stereovision system enables real-time, three-dimensional ultrasound localization of urinary stones.

Benefit: The lithotripter is versatile and designed for patient comfort, and its various configurations makes it adaptable to all patient sizes.

Sources: Global Newswire, August 3, 2011;;

Name: Herculink Elite Renal Stent System

Manufacturer: Abbott, Abbott Park, Ill.

Approval Date: August 10, 2011

Purpose: The stent system is used to treat renal artery stenosis in patients with uncontrolled hypertension. Over time, narrowed kidney arteries can lead to kidney failure and an increased risk of heart disease, stroke, and peripheral artery disease.

Description: The device consists of two components, the stent and the delivery system. The stent is an implant constructed of cobalt chromium, laser-cut into a mesh shape. It is mounted onto a delivery catheter. The stent system is inserted after balloon angioplasty.

Benefit: The device was approved on the basis of results from the Herculink Elite Cobalt Chromium Renal Stent Trial (HERCULES). The study met its primary endpoint, with a low restenosis rate of 10.5% at nine months after treatment. Few adverse events were noted, and 99% of patients experienced no kidney-related complications within 30 days after treatment. At 9 months, systolic blood pressure was reduced in most patients.


Name: Vysis ALK FISH Test

Manufacturer: Abbott, Abbott Park Ill.

Approval Date: August 29, 2011

Purpose: A molecular diagnostic test is now approved to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in patients with non–small-cell lung cancer (NSCLC).

Description: The test is designed to identify ALK-positive NSCLC patients for Pfizer’s approved NSCLC therapy, crizotinib (Xalkori), an oral first-in-class ALK inhibitor. (Crizotinib is discussed in this month’s Pharmaceutical Approval Update column on page 719.) Fluorescence in situ hybridization (FISH) technology is used to detect rearrangements of the gene on the 2p23 chromosome.

Benefit: The test offers a standardized way of identifying the 3% to 5% of patients who might be able to benefit from the new therapy. The Abbott–Pfizer collaboration marks a breakthrough in the advancement of personalized medicine and companion diagnostics that may help a subset of patients receive treatment according to their genetic profile.



Medtronic and the FDA have notified health care professionals of a Class I recall of the SynchroMed II Infusion system. The problem, thought to be related to the formation of a film within the pump battery, can lead to the sudden loss of therapy and the return of underlying symptoms or withdrawal symptoms. The recall includes the SynchroMed II Implantable Infusion Pump, Models 8637-20 and 8637-40, which were distributed between May 2004 and July 8, 2011.

The SynchroMed II Implantable Programmable Drug Pump is part of the infusion system. This infusion pump delivers morphine sulfate to treat chronic pain, ziconotide for severe pain, and baclofen for severe spasticity, and floxuridine and methotrexate for cancer. Patients are being advised to carry their identification cards with them at all times and to contact their physicians immediately if they experience a return of symptoms or hear a device alarm.

Source: FDA, September 12, 2011