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P T. 2011;36(8): 469-472, 477-478

New Drugs/Drug News/New Medical Devices August 2011


Xarelto Reduces Risk Of Blood Clots After Surgery

The FDA has approved rivaroxaban (Xarelto, Janssen) to reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee- or hip-replacement surgery. The tablets are taken once daily. Patients who are undergoing a knee replacement should take the drug for 12 days; patients who are undergoing a hip replacement should take it for 35 days.

In a study involving hip-replacement surgery, venous thromboembolic events (VTEs) developed in 1.1% of rivaroxaban patients and in 3.9% of those receiving enoxaparin (Lovenox, Sanofi-aventis). In another study, 2% of rivaroxaban participants developed VTE compared with 8.4% of those receiving enoxaparin. Bleeding was the most common side effect.

Other anticlotting drugs include fondaparinux (Arixtra, GlaxoSmithKline), dalteparin (Fragmin, Pfizer), warfarin (Coumadin, Bristol-Myers Squibb), and heparin.

Rivaroxaban is also discussed in this month’s Continuing Education Credit article on atrial fibrillation (page 525).

Source: FDA, July 5, 2011

Brilinta, an Antiplatelet Agent For Acute Coronary Syndromes

AstraZeneca has been granted approval of its heart drug, ticagrelor (Brilinta), which may become a strong rival of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-aventis). Ticagrelor is indicated to reduce cardiovascular deaths and heart attacks in patients with acute coronary syndromes (ACS). The drug prevents the formation of new blood clots, thus maintaining blood flow to help decrease the risk of future cardiovascular events.

A boxed warning mentions a risk of bleeding and reduced effectiveness if the drug is taken with more than 100 mg of aspirin per day. In clinical trials, ticagrelor was more effective than clopidogrel in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 mg, according to the FDA.

Ticagrelor was approved in Europe as Brilique. A Risk Evaluation and Mitigation Strategy (REMS) and a patient Medication Guide are provided.

Sources: Bloomberg; Fierce Biotech; Heartwire, July 20, 2011

Generic Arixtra

Dr. Reddy’s has announced the FDA’s final approval of its Abbreviated New Drug Application (ANDA) for fondaparinux sodium injection, the generic version of GlaxoSmithKline’s Arixtra, an anticoagulant. The approval covers strengths of 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL, and 10 mg/0.8 mL in prefilled, color-coded, single-dose syringes with an automatic needle safety device.

Fondaparinux, an anticoagulant, is a complex molecule that is difficult to make on a large scale, according to Dr. Reddy’s. The company will be using a patented process developed by Alchemia Ltd.

Sources: Dr. Reddy’s/Alchemia Ltd., Associated Press, July 13, 2011


Boostrix Vaccine For Oldest Age Group

Boostrix (GlaxoSmithKline) has been approved to prevent tetanus, diphtheria, and pertussis in people 65 years of age and older. The vaccine was first approved in 2005 for adolescents 10 through 18 years of age. In 2008, the approval was extended to include adults 19 through 64 years of age.

Boostrix is given as a single-dose booster injection. Adverse reactions have included headache, fatigue, and pain at the injection site.

Source: FDA, July 8, 2011

Lialda to Maintain Remission Of Ulcerative Colitis

Shire’s once-daily mesalamine (Lialda) delayed-release tablets are now approved for the maintenance of remission in patients with ulcerative colitis. In 2007, mesalamine was approved for the induction of remission in patients with active, mild-to-moderate ulcerative colitis.

Source: Shire, July 19, 2011


Tamper-Resistant Oxycodone (Oxecta) for Pain

Pfizer and Acura have announced the FDA’s approval of an abuse-resistant form of oxycodone HCl tablets (Oxecta) for patients with acute and chronic moderate-to-severe pain.

An immediate-release Schedule II medication, Oxecta was previously under development as Acurox, which included niacin to deter oral abuse. Pfizer acquired Oxecta when it merged with King Pharmaceuticals in 2010.

Aversion technology is designed to discourage tampering associated with opioid abuse and misuse, such as crushing, chewing, snorting, or injecting. The ingredients form a gel if the tablet is mixed to create a solution, and they irritate the nose if the product is crushed and inhaled. The drug breaks down into crumbled chunks instead of a powder if it is crushed, and it turns sudsy if it is mixed with liquid and drawn into a syringe. Oxecta should not be used in a feeding tube because it may obstruct the tube.

Pfizer will be conducting a study to learn whether the product decreases the consequences of abuse and misuse.

Sources: Bloomberg News, MedPage Today, June 20, 2011

Lazanda (Fentanyl) Nasal Spray Relieves Cancer Pain

Fentanyl nasal spray (Lazanda, Archimedes) has been approved for the management of breakthrough pain in patients 18 years of age and older who have been receiving opioids for underlying persistent cancer pain. In Europe, Lazanda is marketed as fentanyl pectin nasal spray (PecFent).

The drug is delivered as a fine mist spray to the nasal membrane. Each spray forms a gel when it contacts the nasal mucosa; the active ingredient is then rapidly absorbed across the mucus membrane and directly into the bloodstream.

Lazanda is contraindicated in opioid non-tolerant patients and in those with acute or postoperative pain. The product will include a Risk Evaluation and Mitigation Strategy (REMS) program. Fentanyl is a Schedule II controlled substance.

Sources: Archimedes, June 30, 2011; Medical News Today, July 1, 2011


Rules for Generic Labels Are Less Stringent

The Supreme Court has ruled that generic drug companies do not share the same level of responsibility as their brand-name counterparts in updating warning labels about new risks. For instance, consumers may sue the brand-name drug manufacturer for inadequate warnings, but they may not sue a generic drug manufacturer for the same problem.

Generic drug companies must use the same warning labels as the brand-name medications and may not independently change the labels. However, these companies are caught in a bind: they can comply with a state law requiring them to change their labels or with the federal law prohibiting changes, but not both. Given this dilemma, federal law preempts state law under the Constitution’s supremacy clause.

Sources: Cable News Network (CNN); The New York Times, June 23, 2011

Alert for Colistimethate

The American Society of Health-System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP) have warned that potentially fatal dosing errors have occurred with the antibiotic colistimethate for injection. The use of this drug has been increasing because of its value as a last-resort treatment for multidrug-resistant organisms.

Colistimethate is a prodrug; in the U.S., the strengths of all colistimethate-for-injection products are labeled in terms of the base drug (colistin), not the prodrug. The label expresses the strength as 150 mg of colistin base per vial.

Dosing information is also expressed in terms of the colistin base. However, in some journal and Internet references, dosing information is based on the prodrug. Thus, the colistimethate dose has sometimes been ordered but may be confused as a colistin dose. This causes the dose to be approximately 2.5 times higher than intended.

The alert provides information on preventing incorrect dosing of the drug, developing dose limits, restricting prescribing to infectious-disease specialists, and monitoring renal function.

Sources: FDA; ASHP; ISMP; June 30, 2011

Flu Vaccines for 2011–2012

The new FDA-approved influenza vaccine formulations for the 2011–2012 influenza season will include the same virus strains that were used for the 2010–2011 flu season: Afluria (CSL Limited); Fluarix (GlaxoSmithKline); FluLaval (ID Biomedical Corp.); FluMist (Med-Immune); Fluvirin (Novartis); and Fluzone, Fluzone High-Dose, and Fluzone Intradermal (Sanofi Pasteur). Fluzone Intradermal, approved in May 2011, will be available for people 18 to 64 years of age. This vaccine is delivered into the skin, rather than the muscle, with a very small needle.

The strains selected are A/California/7/09 (H1N1)-like virus (pandemic [H1N1] 2009 influenza virus); A/Perth/16/2009 (H3N2)-like virus; and B/Brisbane/60/2008-like virus. It is always possible that an imperfect match may occur between the virus strains that are predicted to circulate and the virus strains that eventually cause the most illnesses. However, even if the vaccine and the circulating strains do not match exactly, the vaccine may reduce the severity of the illness or may prevent influenza-related complications. The Centers for Disease Control and Prevention (CDC) recommends that everyone six months of age and older receive an annual flu vaccination.

Sources: FDA, July 18, 2011; CDC,

Most Drugs Do Not Improve Parkinson’s Psychosis

Although antipsychotic drugs are commonly used in Parkinson’s disease (PD), they can worsen parkinsonism. Evidence of their efficacy is limited, and their use in patients with dementia sometimes increases the risk of death.

In a study of patients with PD from the University of Pennsylvania, about 30% of the prescriptions were for high-potency medications that can actually cause harmful effects. For 98% of prescriptions, there was no proof that the drugs improved symptoms of psychosis in the patients. Only one drug, clozapine (Clozaril, Novartis), does improve psychotic symptoms in PD psychosis, but only 2% of patients received prescriptions for it.

In fiscal year 2008, 50% of patients with PD who also had a diagnosis of psychosis received an antipsychotic drug. Quetiapine (Seroquel, AstraZeneca) was the drug that was prescribed most frequently (in 66% of patients). Comparing fiscal year 2008 with fiscal year 2002, the use of these medications in PD was unchanged. Decreases in risperidone (Risperdal, Janssen) and olanzapine (Zyprexa, Eli Lilly) were offset by an increase in quetiapine and the introduction of aripiprazole (Abilify, Bristol-Myers Squibb/Otsuka).

The frequency of use of these agents has not changed since the FDA issued black-box warnings for antipsychotic agents in patients with dementia. Because psychosis and dementia often coexist in PD patients, risks associated with the use of atypical antipsychotic drugs in this population need to be assessed.

Sources: Reuters, July 19, 2011; Arch Neurol 2011;68(7):899–904

Drug Events and Pregnancy

Autism and Antidepressants

In a preliminary study of pregnant women, those who took antidepressants had a slightly increased risk of having a child with autism. From 2006 to 2008, antidepressant use grew to include about 7.5% of pregnant women, an increase from 5% in 2000 to 2002. Until 1990, fewer than 1% of pregnant women used antidepressants in the first trimester.

Results indicated a doubling in the risk of autism if the mother took an antidepressant at any point in the year before delivery. The risk tripled if she filled the prescription during the first trimester.

The findings did not address whether antidepressants caused autism, but the drugs might have had adverse outcomes in children. The researchers identified 298 children with autism or a similar disorder. They then examined the characteristics of the mothers retrospectively. The children and mothers were compared with 1,507 non-autistic children and their mothers. The link between autism in the child and the mother’s use of antidepressants—predominantly the selective serotonin reuptake inhibitors (SSRIs)—remained even after other factors were considered that might have been related to either condition, such as maternal age, ethnicity, education, birth weight, and place of birth.

The researchers also sought to determine whether the mother’s mental state or the antidepressants were linked with autism. The results indicated an association with treatment but not with the mother’s mental state.

Although the number of children exposed to SSRIs before birth in this population was low, exposure (especially during the first trimester) may modestly increase the risk of autism spectrum disorder. The potential risk associated with exposure must be balanced with the risk of untreated mental health disorders in the mother.

Sources: Am J Obstet Gynecol July 4, 2011 (online); The Wall Street Journal, July 5, 2011

Birth Defects and SSRIs

About 3% to 6% of women take selective serotonin reuptake inhibitors (SSRIs) for depression during pregnancy, say researchers from Finland. Does that put them at risk of giving birth to babies with congenital anomalies, such as septal heart defects, anencephaly, and limb defects? Although a small increased risk of congenital cardiovascular anomalies has been suggested with fluoxetine (Prozac, Eli Lilly) and paroxetine (Paxil, GlaxoSmithKline), no direct teratogenicity for any of the SSRIs has been established.

The researchers performed a retrospective cohort study using data from national registers between 1996 and 2006 on 635,583 births, congenital anomalies, and terminations of pregnancy owing to severe fetal anomalies. Offspring who were exposed to SSRIs (n = 6,976) during the first trimester were compared with offspring who had not been exposed to these drugs.

At first, congenital anomalies appeared to be more common among offspring exposed to SSRIs, but that difference did not remain significant after the team adjusted for confounding factors. Variables that were independently associated with birth defects included maternal age, year of pregnancy (2006 compared with 1996), maternal diabetes, and prescriptions for other psychiatric drugs.

Nonetheless, there was an increased risk of ventricular septal defects after exposure to fluoxetine, even when newborns in the neonatal care unit were excluded from the analysis. The risk of right ventricular outflow tract defects was increased with exposure to paroxetine. Citalopram (Celexa, Forest) was associated with neural tube defects. Most striking was the ten-fold jump in fetal alcohol spectrum disorders in offspring of mothers using SSRIs compared with offspring who had not been exposed.

Women taking SSRIs were 20 times more likely to have purchased other psychiatric drugs, compared with women who did not purchase SSRIs during pregnancy. When the researchers considered only other psychiatric drugs, the association between SSRIs and major congenital anomalies became insignificant. When they categorized polytherapy as consisting of first-trimester use of both SSRIs and other psychiatric drugs, exposure was significantly associated with congenital anomalies.

Exposure to fluoxetine and paroxetine in early pregnancy was associated with a small but established risk of cardiovascular anomalies. The researchers advise follow-up of pregnant women who drink alcohol, smoke, and use other psychiatric drugs while they are taking SSRIs.

Source: Obstet Gynecol 2011;118:111–120 (July)

Chantix May Increase Heart Problems

Smokers who take Pfizer’s varenicline (Chantix) might be increasing their risk of heart problems. Dr. Sonal Singh at Johns Hopkins University warned that this drug, used as an aid in smoking cessation, might raise the risk of heart attacks and irregular heartbeats.

Varenicline blocks nicotine receptors in the brain so that cigarettes become less enjoyable. Today, almost 2,000 cases are pending in the federal court system that attribute adverse neuropsychiatric effects to the drug.

A warning label mentions the possibility of behavioral changes, hostility, agitation, depressed mood, and suicidal thoughts or actions. A boxed warning mentions the possibility of psychological events. Varenicline is banned for use by pilots and air-traffic controllers, because it may cause loss of consciousness and blackouts. It is also not recommended for truck and bus drivers.

Researchers examined data from clinical trials involving 8,216 healthy people who received either varenicline or a placebo. Heart problems were reported in 1.06% who took varenicline and in 0.82% of placebo participants. Although the difference appeared to be 0.24%, the actual risk was calculated at 72%. Dr. Singh said he hesitates to prescribe the drug, because smokers already have cardiovascular (CV) risks, and other options (counseling, nicotine replacements, and bupropion) are available.

Pfizer said that the study had several limitations—mainly that the number of heart problems was so small that it raised concerns about the reliability of the study’s conclusions. In June, the FDA added a warning that varenicline might be associated with a small, increased risk of CV adverse events in patients who already have CV disease.

Sources: Can Med Assoc J,, July 4, 2011; WebMD, Salient News, July 6, 2011,

Label Change: Lower ESA Doses For Lower Cardiovascular Risk

The FDA has recommended more conservative dosing guidelines for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular (CV) events such as stroke, thrombosis, and death.

ESAs are synthetic versions of erythropoietin, which stimulates the cells in bone marrow to produce red blood cells (RBCs). These drugs are approved to treat some forms of anemia resulting from CKD, chemotherapy, and other conditions. ESAs include epoetin alfa (Epogen, Amgen; Procrit, Ortho Biotech) and darbepoetin alfa (Aranesp, Amgen).

The new recommendations are being added to the boxed warning and other sections of the package insert. The lowest possible dose should be used to reduce the need for RBC transfusions. Until now, labels for ESAs have recommended doses to achieve and maintain hemoglobin (Hb) levels within the range of 10 to 12 g/dL in patients with CKD. In the new package insert, this targeted range is removed.

For patients with anemia of CKD who are not on dialysis, ESA therapy may begin only when the Hb level is below 10 g/dL. If the Hb level exceeds 10 g/dL, the dose should be reduced or interrupted.

For patients with anemia of CKD who are on dialysis, ESAs can be started when the Hb level is below 10 g/dL. If the Hb level approaches or exceeds 11 g/dL, the dose should be reduced or interrupted.

The changes are based on data from TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy), which showed that ESAs, when used to target Hb levels higher than 11 g/dL, increased the risk of adverse CV events and provided no additional benefit. The FDA has asked Amgen to conduct more trials. Changes are being added to the current Risk Evaluation and Mitigation Strategy (REMS) for ESAs.

Source: FDA, June 24, 2011

Antirheumatic Drugs May Improve Insulin Resistance

Rheumatoid arthritis (RA) and psoriasis have been associated with diabetes and insulin resistance. Disease-modifying antirheumatic drugs (DMARDs) that act directly against the inflammatory response, such as tumor necrosis factor (TNF) inhibitors and hydroxychloroquine, may improve insulin resistance and reduce the risk of diabetes mellitus.

Doctors from Brigham and Women’s Hospital in Boston examined the relationship between DMARDs and newly diagnosed diabetes. Their study involved 13,905 patients with RA or psoriasis. All participants had at least two diagnoses and one filled prescription for a DMARD before the start of follow-up. The researchers estimated the relative risk of diabetes according to the drug: TNF inhibitors, methotrexate, hydroxychloroquine, and other nonbiologic DMARDs such as sulfasalazine (Azulfidine, Pfizer), cyclosporine (Neoral, Sandimmune, Novartis), and azathioprine (Azasan, Salix; Imuran, Prometheus).

During a mean follow-up period of six months, the researchers identified 267 newly diagnosed cases of diabetes: 55 cases among patients using nonbiologic DMARDs, 80 cases among those using TNF inhibitors, 82 cases among those taking methotrexate, and 50 cases among those using hydroxychloroquine (5,682 treatment episodes). Patients who switched to nonbiologic DMARDs had the highest incidence of diabetes, and those using TNF inhibitors or hydroxychloroquine had the lowest rates. There was a suggestion of a reduced risk with methotrexate, but it was found to be not statistically significant.

The investigators say that the results should be considered hypothetical. Several earlier studies had suggested that TNF inhibitors improved insulin metabolism among patients with RA. Animal studies had also indicated that hydroxychloroquine and the closely related anti-malarial agent chloroquine had direct effects on pancreatic islet cells.

In light of these previous results, the researchers say that their study supports the potential role for systemic immunosuppression in preventing and controlling diabetes.

Source: JAMA 2011;305:2525–2531

Don’t Stop Low-Dose Aspirin

Heart patients who are taking a daily aspirin (81 mg) are advised not to quit their regimen. In a study funded by AstraZeneca and led by Dr. Luis Garcia Rodriguez in Spain, patients who stopped taking low-dose aspirin had a higher risk of a heart attack and related fatalities. The researchers used a British database of 39,513 subjects, 50 to 84 years of age, who began taking the drug between 2000 and 2007.

During an average follow-up of 3.2 years, 1,222 patients had heart attacks or died of coronary-related causes. Within this group, 12% had stopped their regimen. Compared with patients who continued taking aspirin, those who quit therapy had a 50% greater risk for a heart attack or death. Over a period of one year, it was estimated that quitting aspirin might have accounted for four extra non-fatal heart attacks in every 1,000 people.

The authors say that the potential benefits of aspirin probably outweigh the risk of gastrointestinal bleeding, which many patients cite as a reason for discontinuation.

Sources: BMJ, July 19, 2011; heart-wire,, July 20, 2011; The Philadelphia Inquirer, July 25, 2011


Rilutek, an ALS Drug, May Help Bipolar Depression

One cause of depression is thought to be dysregulation of glutamate, the most abundant excitatory neurotransmitter in the body. Riluzole (Rilutek, Sanofi-aventis), commonly used to slow the progression of amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease), reduces the release of glutamate while increasing its uptake. The drug also may delay the need for a tracheostomy, although it is not a cure for ALS.

In some studies, riluzole was effective in treating acute bipolar depression alone or in combination with other antidepressants. Riluzole and other drugs that target glutamate reduce the risk of triggering a switch to mania.

The cause of ALS is unknown. One hypothesis is that motor neurons may be injured by glutamate.

Source: Brain & Behavior, Spring 2011,

Metformin for Mothers, Healthier Babies

The United Kingdom has launched the first trial of an effort to affect the intrauterine environment, and thus the development, of childhood obesity in the womb. A British study just getting under way aims to use medication to change the environment in the uteri of pregnant women in order to improve their children’s health later in life, a concept known as fetal (developmental) programming. By adding drugs or nutritional supplements and changing the diet to influence metabolism, digestion, and temperature in the mothers, scientists hope to set the children on a more healthful path for life.

In animal studies, reducing maternal cholesterol levels in pregnancy with cholestyramine (Questran, Par) or with high doses of vitamin E decreased the offspring’s chance of developing hypercholesterolemia, which is passed from the mother to the fetus and is a risk factor for atherosclerosis.

The U.K. study is aimed at reducing the risk of obesity in children born to obese mothers. So far, about 15 patients have enrolled, and about 400 women are expected to be recruited over the next two or more years. In the study, women who are obese but nondiabetic will receive metformin (Glucophage, Bristol-Myers Squibb) during their pregnancy. Obese women, even those without diabetes, tend to have hyperglycemia during pregnancy. Glucose passes through the placenta to the fetus, causing the fetus to work harder to produce more insulin to handle higher levels of sugar. These newborns tend to be born larger (weighing nine pounds or more) and need to produce more insulin, because their bodies expect to take in higher levels of glucose. Heavy babies have a higher risk of obesity, heart problems, and diabetes in later childhood and adulthood.

The researchers expect metformin to lower maternal glucose levels; this in turn should reduce the amount of glucose transmitted to the fetus. The hoped-for outcome is a smaller newborn with more efficient insulin metabolism.

Although the trial raises a question about whether pregnant women should take drugs that they don’t actually need, metformin is considered safe in pregnant women; in the U.K., it is the first-line treatment for diabetic pregnant women.

Obesity in pregnant women is a major risk factor in stillbirths, maternal death, and blood clots, as well as joint pain, nausea, and heartburn. Early intervention in the womb may be more effective in preventing obesity later in life than advising children and adults to eat better and exercise more.

Source: The Wall Street Journal, July 5, 2011


Marvin M. Goldenberg, PhD, RPh, MS

Name: Inform Dual ISH Test

Manufacturer: Ventana Medical Systems, Tucson, Ariz.

Approval Date: June 14, 2011

Purpose: About 20% of women with breast cancer have tumors that are HER2-positive and are, therefore, candidates for trastuzumab (Herceptin, Genentech). Deciding who might be a good fit may become easier, with the approval of a new genetic screening test.

Description: The test measures the number of copies of the HER2 gene in tumor tissue and is designed to detect amplification of the HER2 gene by light microscopy. The pathologist uses two-color chromogenic in situ hybridization (ISH) in formalin-fixed, paraffin-embedded human breast and gastric tumors.

Benefit: The pathologist can see and count copies of chromosome 17 and HER2 genes on the same slide. In the past, HER2 amplification could be measured only with the fluorescence microscope. With the new test, HER2 and chromosome 17 signals can be viewed directly under a microscope and for longer periods of time.

In a study of tumor samples from 510 patients with breast cancer, the test confirmed the number of copies of the gene in 96% of the HER2-positive samples and identified 92.3% of the HER2-negative tumor samples. Because patients whose tumors are HER2-negative are not usually candidates for trastuzumab, the test can assist physicians in selecting an appropriate treatment.

Sources: FDA and Medscape Today, June 14, 2011,

Name: Pinnacle CoMplete Acetabular Hip System

Manufacturer: DePuy Orthopaedics/Johnson & Johnson, Warsaw, Ind.

Approval Date: June 14, 2011

Purpose: This single-use device is intended for uncemented fixation and as a primary joint replacement prosthesis in total hip arthroplasty. Patients must be skeletally mature and must be experiencing at least moderate pain in the hip joint from non-inflammatory degenerative joint disease, osteoarthritis, or post-traumatic arthritis.

Description: As the first ceramic-on-metal total hip replacement system, the device combines a ceramic ball and a metal socket. The femoral head portion of the implant is made of ceramic, and the acetabular (socket) component is a metal alloy. Ceramic-on-ceramic, ceramic-on-polyethylene, metal-on-polyethylene, and metal-on-metal hip-replacement devices have been approved previously.

Benefit: Pain is reduced, and the patient’s ability to move is restored. In a two-year trial, no difference was observed between patients who received the ceramic-on-metal system and those who received a metal-on-metal implant. Two patients who received the Pinnacle product needed revision surgery to replace the new implant, compared with three control patients who required a second surgery.

Contraindications: The Pinnacle system should not be used in patients with an infection that could spread to other areas of the body; osteoporosis or severe osteopenia; a weakened or deformed upper femur; skeletal immaturity; nerve or muscle disease that could affect walking or weight bearing; cancer; renal impairment; or an allergy or sensitivity to metal. Pregnant women are not candidates for the device because of the unknown effects of metal ions on the fetus.

Sources: FDA, June 13, 2011; Med Page Today,

Name: Azficel-T (laVív)

Manufacturer: Fibrocell Science, Inc., Exton, Pa.

Approval Date: June 21, 2011

Purpose: This autologous dermal filler is used to improve the appearance of moderate-to-severe wrinkles of the nasolabial fold in adults.

Description: The patient’s own skin cells (fibroblasts) are extracted from behind the ear. The cells are sent to the company’s laboratory, where they undergo a multiplication process for about three months. In normal skin, fibroblasts help to produce collagen. The cells are then frozen until needed. Over a series of three treatment sessions, typically three to six weeks apart, the cells are injected into the patient’s nasolabial folds to reduce the appearance of smile lines.

Benefit: In two phase 3 studies, more patients responded positively to laVív than to placebo. laVív improved the appearance of nasolabial fold wrinkles for the six months of follow-up after the third and final treatment. Injection-site reactions usually resolved within one week. Because the biological process works over a period of time, laViv can provide natural-looking results. Fibrocell plans to set up a registry to further evaluate the safety of the filler.

Precaution: laViv should be administered only by dermatologists and plastic surgeons who complete a company-sponsored training program in biopsy collection, shipping procedures, product preparation, and injection technique. Specialists are also taught how to ensure that patients receive their own cells.

Sources: FDA,, and Medscape Today, June 22, 2011,