FDA Patient Safety News: Show #101, August 2010

Warning on Proton Pump Inhibitors and Fracture Risk

FDA is cautioning healthcare professionals and patients that proton pump inhibitors (PPIs) may increase the risk of fractures of the hip, wrist and spine. The drugs' labeling will be revised to reflect these concerns. PPIs are used to reduce gastric acidity, and include Nexium (esomeprazole), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Protonix (pantoprazole), Aciphex (rabeprazole) and Prevacid (lansoprazole).

The new safety information is based on FDA's review of several epidemiological studies. These studies found that patients who received high doses of the drugs or took them for a year or more had the greatest fracture risk. Since most of these patients were older than 50, the increased risk was observed mainly in this age group.

Healthcare professionals prescribing proton pump inhibitors should consider the possibility of an increased fracture risk, and whether a lower dose or shorter duration of therapy might be possible. Patients at risk for osteoporosis should have their bone status managed, and should supplement their diets with adequate amounts of vitamin D and calcium.

Patients taking prescription PPIs should understand the possibility of an increased fracture risk, but they should be told not to stop their medication without consulting their healthcare professional. People using over-the-counter PPIs to treat heartburn should be cautioned not to take these drugs for more than 14 consecutive days, and not to take more than three 14-day treatment courses in one year.

Additional Information:

FDA MedWatch Safety Alert. Proton Pump Inhibitors (PPI): Class Labeling Change. May 25, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213321.htm

Update on Counterfeit Polypropylene Mesh

FDA now has more information on the counterfeiting of Bard flat polypropylene surgical mesh, commonly known as Marlex mesh. This was first reported earlier this year. The counterfeit products, which were distributed between October 21, 2008 and October 27, 2009, were labeled with the C.R. Bard/Davol brand name, but they were not manufactured by Bard.

FDA testing has now found that the counterfeit samples are not sterile, although they are labeled as sterile. This can mean an increased risk of infection if they are implanted in a patient. FDA tests have also shown that the weave pattern and structure of the counterfeit mesh is different from the authentic. Also, the counterfeit may not have properly finished edges, which could allow it to unravel. FDA is continuing to test samples of the counterfeit mesh as part of its ongoing investigation.

RAM Medical Inc., a medical product distributor, sold the counterfeit products to the following six distributors:

• Amerimed Corporation
• Henry Schein Inc.
• Marathon Medical Corporation
• Medline Industries
• MMS - A Medical Supply Company
• Q-Med Corporation

These distributors then sold them to hospitals, or possibly to other distributors. RAM Medical is recalling all of the counterfeit mesh from the recalled lots.

Here's what healthcare professionals and facilities should do.

• Lot numbers of the counterfeit products can be found in the link below.

• Anyone who has surgical mesh from any of these lots that came from one of the above six distributors, contact RAM at 973-633-0400 for instructions on returning it.

• Anyone who has mesh from one of the listed lots that came from another distributor, contact Bard at 1-800-556-6275 to see if it is authentic.

• Examine stock of polypropylene mesh from other manufacturers. If anything in the packaging or labeling indicates a possible counterfeit product, contact the manufacturer and FDA's Office of Criminal Investigations at 1-800-551-3989.

Additional Information:

FDA MedWatch Safety Alert. Counterfeit Polypropylene Surgical Mesh: Initial Communication. June 8, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204224.htm

Thrombosis with Off-Label Promacta Use

GlaxoSmithKline is warning healthcare professionals about the risk of thrombosis if patients with chronic liver disease are treated with Promacta (eltrombopag). Promacta is approved to treat thrombocytopenia in certain adult patients with chronic idiopathic thrombocytopenic purpura (ITP).

The company notification was based on findings from a clinical trial designed to find out whether Promacta might reduce the need for platelet transfusions in patients with thrombocytopenia from chronic liver disease. The study was stopped after more patients in the Promacta group experienced portal venous system thromboses than in the control group.

The company's letter states that Promacta is not indicated for treating thrombocytopenia in patients with chronic liver disease. The letter also reminds practitioners that Promacta treatment should be aimed at increasing the platelet count to a level that reduces the risk of bleeding, and not to normalize the platelet count. The company also says to use caution when administering Promacta to patients with known risk factors for thromboembolism.

Additional Information:

FDA MedWatch Safety Alert. Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease. May 12, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211796.htm

Severe Liver Injury with Orlistat (Xenical, Alli)

The labeling for the weight loss drug orlistat will include new safety information about rare cases of severe liver injury in patients taking this drug. Orlistat is sold by prescription as Xenical in 120 mg strength and over the counter as Alli in 60 mg strength.

This action resulted from a recently completed FDA review that identified thirteen cases of severe liver injury with orlistat during an approximate ten-year period. One case in the United States involved Alli and twelve cases in foreign countries involved Xenical. During the same time period, an estimated 40 million people worldwide used Xenical or Alli.

Although it has not been established that orlistat causes liver injury, patients should be told to contact their healthcare professional if they experience symptoms of liver dysfunction. These include itching, yellow eyes or skin, dark urine, light-colored stools, or loss of appetite.

If liver injury is suspected, clinicians should advise patients to stop taking orlistat immediately. Healthcare professionals and consumers should report adverse events with Xenical or Alli through FDA's MedWatch Program.

Additional Information:

FDA MedWatch Safety Alert. Orlistat (marketed as Alli and Xenical): Labeling Change. May 26, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213448.htm

Dosing Errors with Certain Oral Syringes

The Institute for Safe Medication Practices (ISMP) recently pointed out that measuring doses with certain oral syringes can be confusing for healthcare practitioners and patients, and that this can lead to overdoses.

This type of syringe is packaged with drugs such as morphine sulfate concentrated oral solution. The plunger inside the syringe has a pointed end instead of a flat one. It is made that way so there is less residual solution in the syringe after the drug is delivered. But some people do not understand what part of the plunger to line up against the markings on the syringe barrel when they're measuring the dose.

The correct way to measure the dose is to align the widest part of the syringe plunger with the calibrated markings on the barrel. If the tip of the plunger is mistakenly used to line up the dose, the plunger will be pulled too far out and the syringe will contain more than the intended dose.

ISMP cites a case where the nursing staff in several long term care facilities may have done just that --- measured doses incorrectly by using the tip of the plunger to line up the dose. ISMP notes that the Medication Guide for Roxane's morphine sulfate oral solution gives detailed instructions to patients on how to use the syringe properly, but nurses, pharmacists and other healthcare professionals should also be reminded about the right way to measure a dose with these syringes.

Additional Information:

ISMP Medication Safety Alert – Community/Ambulatory Care Edition.
http://www.ismp.org/newsletters/ambulatory/archives/201004-2.asp

Reporting Adverse Events to MedWatch

An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns.

MedWatch reports alone rarely confirm a causal relationship between an adverse event and a medical product. It may take a formal epidemiologic study or a controlled clinical trial to do that. Still, MedWatch reports are vital in helping to make sure that medical products are safe, because they provide a rapid signal to FDA that problems may be occurring.

FDA depends on reports from healthcare professionals and consumers to keep the MedWatch system working. Here are the kinds of problems to report:

• Any serious adverse event that might be associated with a drug, biologic, medical device, dietary supplement or cosmetic product. FDA is particularly interested in serious adverse events that are not listed in the product labeling. "Serious" means fatalities, hospitalizations, and medically significant events.

• Therapeutic failures where the drug or device failed to work as it should (e.g., if a patient has to switch from one brand of a drug to another because the original one was ineffective).

• Use errors with medications or devices, including situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or packaging.

• Product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging.

FDA encourages people to report these problems to MedWatch even if you are not sure that the product was the cause. It is easy to report by internet, phone, fax, or mail. See "Additional Information" link below.

Additional Information:

MedWatch – The FDA Safety Information and Adverse Event Reporting Program.
http://www.fda.gov/Safety/MedWatch/default.htm

Lifeline and ReviveR AED Battery Packs Recalled

Defibtech is recalling certain battery packs used in Lifeline and ReviveR automatic external defibrillators (AED). These battery packs may cause the AED to inappropriately cancel the charge and be unable to deliver therapy. The company has received four malfunction reports from AED users.

This recall affects DBP-2800 battery packs shipped before June 4, 2007. The affected packs have serial numbers between 202001005 and 202005916 or between 206001001 and 206009871.

Anyone who has a Lifeline or ReviveR AED should check the battery pack's serial number and contact the company if it is affected by the recall. Defibtech will be sending corrective software to users who have affected battery packs.

In the meantime, the company says the AED can be kept in service until the software update card is received. But make sure there is a backup battery pack or a backup AED available. If your AED cancels a shock during a rescue and shuts down with service code 1003, replace the battery pack and continue with the rescue.

Additional Information:

FDA MedWatch Safety Alert. Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall. June 6, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214916.htm

Lifeline and ReviveR AED Battery Packs Recalled

Additional Information:

Defibtech. Urgent Medical Device Safety Information and Correction - Defibtech DBP-2800 Battery Packs. May 20, 2010.
http://www.defibtech.com/BatteryFA-usa.html

Help FDA Stop “Bad Ads”

FDA monitors the way drug companies advertise and promote prescription drugs to help assure that the information is accurate and balanced. But it is difficult for the agency to check on these activities when they take place in doctors' offices, or in industry-sponsored meetings and training sessions. That is where the new "Bad Ad" program comes in. By taking part in this FDA program, healthcare professionals can help ensure that prescription drug advertising is truthful, and that it's not misleading. The "Bad Ad" program asks healthcare professionals to recognize misleading or inaccurate promotion by drug companies, and then report it to the FDA. That way, FDA can take steps to address possible violations.

Here are some examples of situations to look for:

• A speaker's slides describe a drug's efficacy, but there is no risk information. That is considered misleading because the presentation doesn't provide a fair balance of benefit and risk information.

• A company representative in a commercial exhibit hall says that a drug is effective for a use that has not been approved by FDA. This is promoting an "off-label" use, and it is illegal.

• Overstating the effectiveness of a drug --- for example, saying a drug works in as little as three days, when most of the patients in the drug's clinical trials did not show results for three months.

FDA is kicking off the Bad Ad program at major medical conferences this summer, so stop by an FDA booth to learn more about recognizing and reporting misleading drug promotions. In any case, the most important thing is to report these to the FDA. Just send an email to badad@fda.gov or call (877) RX- DDMAC.

Additional Information:

FDA Bad Ad Program. Truthful Prescription Drug Advertising and Promotion. May 14, 2010.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm

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