FDA Patient Safety News: Show #99, June 2010

New Formulation for OxyContin

FDA has approved a new formulation of the controlled-release drug OxyContin that is designed to be more difficult to manipulate by someone trying to misuse or abuse the medication. OxyContin tablets contain the opioid analgesic oxycodone, which is released gradually after the tablet is swallowed. People intent on abusing the drug have been able to release more of the medication all at once by crushing or chewing the tablets, or by dissolving them and injecting the liquid.

The new formulation makes it more difficult for people to defeat the controlled-release properties of the drug by cutting or crushing the tablets. And if someone tries to dissolve the tablets, the result will be a gummy substance that would be difficult to inject through a syringe. Although the new formulation may not prevent all abuse of OxyContin, it is a step in the right direction. The manufacturer will conduct a study to evaluate how well the new formulation reduces abuse and misuse of the drug.

Additional Information:

FDA Press Release. FDA Approves New Formulation for OxyContin. April 5, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm207480.htm


First Absorbable Sealant Patch for Cardiovascular Surgery

FDA recently approved the first absorbable fibrin sealant patch to prevent bleeding from small blood vessels during cardiovascular surgery. The patch is called TachoSil and it is made by Nycomed. The patch provides an additional tool for surgeons to help control mild and moderate bleeding when standard surgical techniques are ineffective or impractical. TachoSil should not be used intravascularly.

The effectiveness of TachoSil was evaluated in a study of 119 cardiovascular surgery patients. Nearly three-quarters of the group who received TachoSil stopped bleeding within three minutes, compared to about one third of the comparator group. Adverse reaction rates were not statistically different between the two groups.

Additional Information:

FDA Press Release. FDA Approves First Biodegradable Sealant Patch for Cardiovascular Surgery. April 5, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm207422.htm


First Absorbable Sealant Patch for Cardiovascular Surgery

FDA recently approved the first absorbable fibrin sealant patch to prevent bleeding from small blood vessels during cardiovascular surgery. The patch is called TachoSil and it is made by Nycomed. The patch provides an additional tool for surgeons to help control mild and moderate bleeding when standard surgical techniques are ineffective or impractical. TachoSil should not be used intravascularly.

The effectiveness of TachoSil was evaluated in a study of 119 cardiovascular surgery patients. Nearly three-quarters of the group who received TachoSil stopped bleeding within three minutes, compared to about one third of the comparator group. Adverse reaction rates were not statistically different between the two groups.

Additional Information:

FDA Approval Page. TachoSil. April 6, 2010.
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm207482.htm


Reduced Effect from Plavix in Some Patients

Through a new boxed warning, the FDA is alerting healthcare professionals about a subgroup of patients who cannot effectively metabolize the anti-platelet drug Plavix (clopidogrel).

These patients, called "poor metabolizers," have little or no activity of the liver enzyme CYP2C19, which converts Plavix to its active form, so they may not experience the full anti-clotting benefits of the drug.

Practitioners should know that tests are available to identify genetic differences in CYP2C19 function and thus identify poor metabolizers. They should consider using other anti-platelet medication or an alternative dosing strategy for these patients. And although raising the dose of Plavix in poor metabolizers can increase anti-platelet response, an appropriate dose regimen has not been established in a clinical trial.

Additional Information:

FDA MedWatch Safety Alert. Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug. March 12, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204256.htm


Muscle Injury from High Doses of Zocor

FDA is informing healthcare professionals that a preliminary review of a large clinical trial shows an increased risk of muscle injury in patients taking the highest dose of the statin drug simvastatin. Simvastatin is sold as Zocor, and is also an ingredient in Vytorin (ezetimibe/simvastatin) and Simcor (niacin extended-release/simvastatin).

Myopathy is a known side-effect of all statin drugs, as is rhabdomyolysis, a potentially life-threatening type of myopathy. The higher the statin dose, the greater the risk of developing myopathy or rhabdomyolysis. The clinical trial showed that the risk of myopathy is much higher in patients taking 80 mg of simvastatin, which is the highest approved dose, than in those taking 20 mg.

The risk of myopathy is also increased when simvastatin is used with certain other medications. In fact, simvastatin should be avoided in people taking certain drugs, and there are specific dose limits when it's prescribed with other drugs.

FDA will continue to evaluate other sources of information to further define the risk of myopathy from high doses of simvastatin, and will share this information with practitioners and the public as soon as it is available. In the meantime, when deciding to use simvastatin, practitioners should consider the drug's potential risks and known benefits compared to other cholesterol-lowering therapies. Before prescribing simvastatin, prescribers should carefully review the patient's medications for potential drug-drug interactions.

Additional Information:

FDA MedWatch Safety Alert. Zocor (simvastatin): increased risk of muscle injury with high doses. March 19, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205404.htm


Companies to Stop Marketing Unapproved Nitroglycerin Tablets

FDA has told two drug companies to stop marketing sublingual nitroglycerin tablets that have not been approved as safe and effective by the FDA. Glenmark Generics and Konec Inc., have been selling unapproved nitroglycerin in 0.3, 0.4, and 0.6 mg dosages. FDA has seen significant problems with the quality and efficacy of nitroglycerin tablets that are not approved.

Although Glenmark Generics and Konec must stop shipping these drugs by September 2010, there should not be a supply problem. Pfizer's Nitrostat tablets, which are FDA-approved, come in the same dosages.

Hospitals and pharmacies that now buy the unapproved nitroglycerin tablets will need to switch to approved ones. Patients who currently take the unapproved products should continue to take their medications and talk to their healthcare professional about their treatment options.

Additional Information:

FDA Press Release. FDA Orders 2 Companies to Stop Marketing Unapproved Nitroglycerin Tablets. March 16, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm204744.htm


Boxed Warning for Exjade

Novartis Oncology has alerted healthcare professionals about a new boxed warning and other safety changes in the labeling for Exjade (deferasirox). Exjade is used to treat transfusional hemosiderosis, the chronic iron overload that can result from multiple blood transfusions.

The boxed warning emphasizes that Exjade may cause renal or hepatic impairment, including kidney or liver failure. It also highlights the risk of gastrointestinal hemorrhage. These kidney, liver and GI reactions, which are sometimes fatal, have been seen more often in elderly patients and those with high-risk myelodysplastic syndromes, underlying renal or hepatic impairment, or low platelet counts.

Patients on Exjade must be closely monitored for kidney and liver function before starting and during therapy.

Additional Information:

FDA MedWatch Safety Alert. Exjade (deferasirox): Boxed Warning. February 18, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200850.htm


Hemolysis Risk with WinRho SDF

Baxter Healthcare and Cangene Corporation are notifying healthcare professionals that intravascular hemolysis (IVH), which can be fatal, has occurred in patients with immune thrombocytopenic purpura treated with WinRho SDF, an intravenous immune globulin product. Intravascular hemolysis can lead to severe anemia, renal failure, acute respiratory distress syndrome, disseminated intravascular coagulation, and multi-system organ failure.

Elderly patients with co-morbid conditions appear to be at higher risk for developing acute hemolytic reactions.

Here are the recommendations that now appear in the boxed warning for this product:

• Closely monitor patients in a healthcare setting for at least eight hours after administering WinRho SDF. But be aware that IVH can occur even after that time.

• Perform a baseline dipstick urinalysis. Repeat this at two and four hours after administration, and at the end of the monitoring period.

• Instruct patients to watch for symptoms of IVH, including back pain, shaking chills, fever, discolored urine and hematuria.

• If you suspect IVH, confirm this with laboratory tests, including plasma hemoglobin, haptoglobin, LDH, direct and indirect plasma bilirubin, and dipstick urinalysis.

Finally, as a reminder, it is important to monitor all patients receiving intravenous immune globulin products for signs and symptoms of hemolysis, and to perform confimatory lab tests if they occur.

Additional Information:

FDA MedWatch Safety Alert. WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis. March 10, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203739.htm


Avoiding Problems with Temporary Cardiac Pacing

A recent FDA article in the journal Nursing2010 describes a variety of problems associated with temporary pacing leads. Temporary pacing is used during emergency treatment of some bradyarrhythmias and tachyarrhythmias, and also used prophylactically for patients at risk for bradyarrhythmias during cardiovascular surgery.

Staff in one hospital reported many inadvertent disconnections with a new reusable extension cable that was supposed to connect the lead to the pacemaker. This problem had not occurred with the old cable. Staff resorted to using surgical tape to maintain the connection between the pacing wire and the extension cable, a practice that's not recommended in the instructions.

Leads can also fracture. In one case, the distal tip of a temporary epicardial lead broke off and remained in the patient when the lead was removed 13 days after surgery. The lead manufacturer had recommended only a 7-day implant duration.

There is also a risk of misconnection when using a balloon temporary pacing catheter that has an extra lumen for infusion, hemodynamic monitoring or blood sampling. In one case, a patient's caregiver accidentally connected I.V. tubing to the pacing catheter's balloon inflation port, causing the balloon to burst inside the patient.

The article recommends several ways to help avoid problems like these. They include verifying that proper connections have been made throughout the entire pacing system, and knowing your hospital's policy and procedures for handling defective devices.

Additional Information:

FDA Medical Device Safety. Take the Lead on Safety With Temporary Cardiac Pacing. March 9, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm203731.htm


Caution about Sexual Enhancement Supplements

Your patients can easily find them on the internet --- products advertised as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs, which might mislead people into thinking they're harmless.

In fact, an FDA investigation of a number of these sexual enhancement products found that a third of them actually contained the same or similar ingredients as those in Viagra (sildenafil citrate), Cialis (tadalafil), and Levitra (vardenafil HCl) - and sometimes in very large amounts. FDA has issued many alerts about these products over the past several years, but their number appears to be growing.

As with the approved drugs for erectile dysfunction, taking these products can be especially dangerous for people who are on prescription drugs that contain nitrates, such as nitroglycerin, because they can interact to cause dangerous hypotension. Patients with diabetes, hypertension, high cholesterol, or heart disease often take nitrates, and since erectile dysfunction is common in men with these conditions, they may seek out these supposedly natural products. To make matters worse, it is unlikely that these so-called supplements are made under the same quality controls as prescription drugs. This means that the identity or amount of active ingredients could vary greatly or the products could contain other potentially risky ingredients not listed on the label.

So caution your patients not to be misled by claims of "all natural" ingredients in products marketed for sexual enhancement. Warn patients who should not take approved prescription drugs for erectile dysfunction that taking these sexual enhancement products could pose similar or worse risks. And tell patients who are using prescription drugs to treat erectile dysfunction not to take these so-called "supplements" because doing so could expose them to dangerously high doses of the active ingredient in their prescriptions.

Additional Information:

FDA Consumer Update. Hidden Risks of Erectile Dysfunction "Treatments" Sold Online. February 21, 2009.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048386.htm


Caution about Sexual Enhancement Supplements

Your patients can easily find them on the internet --- products advertised as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs, which might mislead people into thinking they're harmless.

In fact, an FDA investigation of a number of these sexual enhancement products found that a third of them actually contained the same or similar ingredients as those in Viagra (sildenafil citrate), Cialis (tadalafil), and Levitra (vardenafil HCl) - and sometimes in very large amounts. FDA has issued many alerts about these products over the past several years, but their number appears to be growing.

As with the approved drugs for erectile dysfunction, taking these products can be especially dangerous for people who are on prescription drugs that contain nitrates, such as nitroglycerin, because they can interact to cause dangerous hypotension. Patients with diabetes, hypertension, high cholesterol, or heart disease often take nitrates, and since erectile dysfunction is common in men with these conditions, they may seek out these supposedly natural products. To make matters worse, it is unlikely that these so-called supplements are made under the same quality controls as prescription drugs. This means that the identity or amount of active ingredients could vary greatly or the products could contain other potentially risky ingredients not listed on the label.

So caution your patients not to be misled by claims of "all natural" ingredients in products marketed for sexual enhancement. Warn patients who should not take approved prescription drugs for erectile dysfunction that taking these sexual enhancement products could pose similar or worse risks. And tell patients who are using prescription drugs to treat erectile dysfunction not to take these so-called "supplements" because doing so could expose them to dangerously high doses of the active ingredient in their prescriptions.

Additional Information:

FDA MedWatch Safety Alert. RockHard Weekend - product contains undeclared drug ingredient. November 18, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191052.htm


Caution about Sexual Enhancement Supplements

Your patients can easily find them on the internet --- products advertised as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs, which might mislead people into thinking they're harmless.

In fact, an FDA investigation of a number of these sexual enhancement products found that a third of them actually contained the same or similar ingredients as those in Viagra (sildenafil citrate), Cialis (tadalafil), and Levitra (vardenafil HCl) - and sometimes in very large amounts. FDA has issued many alerts about these products over the past several years, but their number appears to be growing.

As with the approved drugs for erectile dysfunction, taking these products can be especially dangerous for people who are on prescription drugs that contain nitrates, such as nitroglycerin, because they can interact to cause dangerous hypotension. Patients with diabetes, hypertension, high cholesterol, or heart disease often take nitrates, and since erectile dysfunction is common in men with these conditions, they may seek out these supposedly natural products. To make matters worse, it is unlikely that these so-called supplements are made under the same quality controls as prescription drugs. This means that the identity or amount of active ingredients could vary greatly or the products could contain other potentially risky ingredients not listed on the label.

So caution your patients not to be misled by claims of "all natural" ingredients in products marketed for sexual enhancement. Warn patients who should not take approved prescription drugs for erectile dysfunction that taking these sexual enhancement products could pose similar or worse risks. And tell patients who are using prescription drugs to treat erectile dysfunction not to take these so-called "supplements" because doing so could expose them to dangerously high doses of the active ingredient in their prescriptions.

Additional Information:

FDA MedWatch Safety Alert. Nature & Health Co. supplement products: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac. July 15, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172312.htm


Caution about Sexual Enhancement Supplements

Your patients can easily find them on the internet --- products advertised as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs, which might mislead people into thinking they're harmless.

In fact, an FDA investigation of a number of these sexual enhancement products found that a third of them actually contained the same or similar ingredients as those in Viagra (sildenafil citrate), Cialis (tadalafil), and Levitra (vardenafil HCl) - and sometimes in very large amounts. FDA has issued many alerts about these products over the past several years, but their number appears to be growing.

As with the approved drugs for erectile dysfunction, taking these products can be especially dangerous for people who are on prescription drugs that contain nitrates, such as nitroglycerin, because they can interact to cause dangerous hypotension. Patients with diabetes, hypertension, high cholesterol, or heart disease often take nitrates, and since erectile dysfunction is common in men with these conditions, they may seek out these supposedly natural products. To make matters worse, it is unlikely that these so-called supplements are made under the same quality controls as prescription drugs. This means that the identity or amount of active ingredients could vary greatly or the products could contain other potentially risky ingredients not listed on the label.

So caution your patients not to be misled by claims of "all natural" ingredients in products marketed for sexual enhancement. Warn patients who should not take approved prescription drugs for erectile dysfunction that taking these sexual enhancement products could pose similar or worse risks. And tell patients who are using prescription drugs to treat erectile dysfunction not to take these so-called "supplements" because doing so could expose them to dangerously high doses of the active ingredient in their prescriptions.

Additional Information:

FDA MedWatch Safety Alert. Stiff Nights product contains undeclared drug ingredient. November 5, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189300.htm


Phase-Out of CFC Inhalers

FDA is informing healthcare practitioners and patients that certain metered-dose inhalers used to treat asthma and chronic pulmonary obstructive disease will be gradually removed from the market because they use chlorofluorocarbons (CFCs) as propellants. CFCs released into the environment deplete the protective ozone layer in the atmosphere. They have been banned from consumer aerosol products for a long time.

Seven inhalers are affected by this action. Four of them are no longer being made. The remaining three, to be phased out over the next few years, are Aerobid, Combivent and Maxair. Aerobid cannot be sold in the U.S. after June 30, 2011. Combivent and Maxair cannot be sold after December 31, 2013. Manufacturers of these inhalers could stop selling them prior to these deadlines.

Patients still using one of these three inhalers should talk to their doctors about switching to another product, such as inhalers that use propellants other than CFCs, inhaled powders that do not use a propellant, or liquids administered with a nebulizer. Patients should understand that these products may look, feel or taste different from the ones they are accustomed to, and may need instruction in how to use them properly.

Additional Information:

FDA. Phase-Out of CFC Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. April 19 2010.
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm193896.htm



FDA Patient Safety News is available at www.fda.gov/psn