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U.S. Department of Health and Human Services

Show #26, April 2004

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Show #26, April 2004

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 New Medical Products

April2004FDA Patient Safety News Homepage
New Drug for Mesothelioma (Video, print, and e-mail functions)
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The FDA recently approved a new drug used to treat malignant pleural mesothelioma, a rare cancer usually associated with asbestos exposure. The drug is called Alimta, or pemetrexed disodium, and it's distributed by Eli Lilly and Company. Alimta is intended to be used along with cisplatin.

Only about 2,000 new cases of mesothelioma are diagnosed each year in the U.S. Patients live, on average, nine to thirteen months after diagnosis.

In a randomized clinical trial, patients receiving Alimta along with cisplatin lived an average of 12 months after the trial began, compared with nine months for those on cisplatin alone.

Alimta must be supplemented with vitamin B-12 and folic acid to decrease the incidence and severity of adverse effects. Those effects include low white blood count, nausea, vomiting, fatigue, rash and diarrhea. Since the drug suppresses the bone marrow, patients are warned to report signs of infection, such as fever and chills.

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 Recalls and Safety Alerts

April2004FDA Patient Safety News Homepage
Warning on Counterfeit Contraceptive Patches (Video, print, and e-mail functions)
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Here's an alert about counterfeit contraceptive patches that contain no active ingredient. They've been sold by an overseas internet site. The counterfeit patches were promoted by this web site as Ortho Evra transdermal patches, which are FDA approved, and made by Ortho-McNeil Pharmaceutical, Inc.

The authentic patch contains an estrogen/progestin combination for contraception. The patch is attached to the woman's skin and left in place for seven days for three consecutive weeks, followed by one week without the patch. Obviously, a woman would be unprotected against pregnancy if she used one of the counterfeit patches.

Distinguishing between the authentic product and the counterfeit isn't difficult in this case. The authentic patch is a 1¾ inch beige square, made of a thin film. It comes in a sealed, opaque, white pouch with the product label attached to one side of the pouch. The lot number and expiration date appear on the attached label, and also on the back of the pouch. The counterfeit product is a slightly smaller brown square made of woven material. It has 5 holes that look like red dots on the middle of the top side of the patch. The counterfeits were sent in simple plastic bags without any identifiers, lot numbers, or expiration date.

The counterfeit patches were purchased from the website www.rxpharmacy.ws

At this point, we've identified several other websites associated with the one selling the counterfeit patches. These include usarxstore.com europeanrx pharmacy.com, and generic.com. All these web sites sold drugs that they claimed were the same as FDA-approved drugs. But in fact, they were from unknown sources and of unknown safety and efficacy.

With the cooperation of the internet service provider, service to these particular websites has now been shut down. FDA is urging people to be suspicious of any drugs they may have purchased from these websites, and to assume that they can’t be considered safe and effective. If they have products purchased from any of these websites, they shouldn't use them, and should contact a healthcare provider immediately. Even though these particular sites were shut down, we can't be certain that they were the only ones selling the counterfeit patches.

This case brings out a larger message for patients about the potential dangers of buying medical products on line. Remind your patients that if they want to buy drugs over the internet, they should have their prescriptions filled only at reputable on-line pharmacies. They should look for sites that bear the seal "Verified Internet Pharmacy Practice Sites.” That shows the site is operating according to the standards of the National Association of Boards of Pharmacy (NABP). Tell your patients to avoid foreign web sites and sites that don't provide a U.S. address and phone number to contact if there's a problem.

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April2004FDA Patient Safety News Homepage
Recall of Certain DURAGESIC Patches (Video, print, and e-mail functions)
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UPDATE April 19, 2004 - Janssen has expanded its US recall to include 5 manufacturing lots of DURAGESIC 75 mcg/hr patches: control numbers 0327192 (exp. 10/05); 0327193 (exp. 10/05); 0327294 (exp. 11/05); 0327295 (exp. 11/05); 0330362 (exp. 12/05). See "Additional Information".



Janssen Pharmaceutica is recalling one lot of DURAGESIC transdermal patches. The patches deliver the opioid fentanyl, used to treat severe chronic pain. A small percentage of the patches in this lot may leak medication because of an improper seal along one edge of the patch.

If the medication leaks from the patch directly onto the patient's skin, overdosing may occur. This can cause nausea, sedation, drowsiness, or potentially life-threatening complications. Caregivers can also be exposed, so anyone who comes in contact with the leaked medication should rinse the exposed skin thoroughly with water. Don't use soap.

Patients could also be underdosed as a result of a leaking patch. In an opioid tolerant patient, this can lead to withdrawal symptoms, such as sweating, sleeplessness and abdominal discomfort.

The affected lot contains DURAGESIC 75 microgram per hour patches with the control number 0327192, expiration date October 2005. You can find the control number on both the outer carton and on each foil pouch that contains a patch. At this time, we don't know of any other dosage strengths or lot numbers that are affected.

If you have any product with control number 0327192, stop using, administering or distributing it. Go to our web site to find Janssen Pharmaceutica's instructions on product return and on helping patients who may have the affected product. Or you can call Janssen directly at 1-800-Janssen.

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April2004FDA Patient Safety News Homepage
Severe Hepatotoxicity with VIRAMUNE (nevirapine) (Video, print, and e-mail functions)
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Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) has notified healthcare professionals about new hepatotoxicity warnings for the drug VIRAMUNE (nevirapine). VIRAMUNE is a non-nucleoside reverse transcriptase inhibitor that's used in combination with other antiretroviral agents to treat HIV-1 infection.

Severe, life-threatening, and in some cases fatal hepatotoxicity has been reported in patients treated with VIRAMUNE. These events are often associated with rash and have included fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure.

Women with CD4 counts greater than 250 cells per cubic millimeter, including pregnant women receiving chronic treatment for HIV infection, are at considerably higher risk of hepatotoxicity. The greatest risk of severe and potentially fatal hepatic events occurs in the first 6 weeks of VIRAMUNE treatment. However, the risk continues after this time and so patients should be monitored closely for the first 18 weeks of treatment with the drug. In some cases, hepatic injury progresses even though VIRAMUNE treatment has been discontinued.

Although this new information describes patients at increased risk, any patient on VIRAMUNE can experience hepatic events and should be monitored carefully. It's also important to counsel all patients that if signs or symptoms of hepatitis, severe skin reactions or hypersensitivity reactions occur, they should discontinue VIRAMUNE treatment and seek medical evaluation immediately. VIRAMUNE should not be restarted in these patients.

You can report adverse reactions to VIRAMUNE and find complete monitoring recommendations on our web site.

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April2004FDA Patient Safety News Homepage
False Positive Results with Ortho Hepatitis B Antibody Tests (Video, print, and e-mail functions)
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Here's a report you might want to share with colleagues in your blood banking facility. Ortho-Clinical Diagnostics, Inc., has sent a letter to blood banks and other health care professionals alerting them to reports of false positive test results with the company's screening test and confirmatory test for hepatitis B antibody. These tests are used by blood banks to screen blood donors. Over the last several months, some donors may have been notified by their local or hospital blood bank that they had a positive hepatitis test because of these false positives.

Ortho is conducting an investigation to try to find the cause of the problem. In the meantime, the company is recommending that blood facilities take certain specific steps to reduce the possibility of getting false positive test results:

-- First, prepare only enough test substrate for use within two hours or less.
-- Where feasible, use the semi-automated wash method for initial and repeat testing.

-- And if using the Ortho Summit Processor, run the Weekly Maintenance software function on a daily basis.

To minimize the potential for false-positives with the Confirmatory Test Kit, the company will be making several changes to the Instructions for Use.

The quality control procedures will have new information on how to calculate results on test samples, and summarize how to determine if a specimen is truly positive. Go to our website for more information, or contact Ortho-Clinical Diagnostics' Customer Technical Services at 1-800-421-3311. For questions about donor re-entry, contact FDA at 301-827-2000.

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 Preventing Medical Errors

April2004FDA Patient Safety News Homepage
Injections Into the Wrong Port of an Implantable Infusion Pump (Video, print, and e-mail functions)
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In a recent article, the Institute for Safe Medication Practices warned about fatal accidents that have occurred with implantable infusion pumps used to deliver drugs intrathecally. This type of drug delivery system is used to administer opiates for intractable chronic pain, and baclofen to treat spasticity associated with MS, cerebral palsy, and spinal cord injuries.

The pump is implanted under the skin, and it's attached to a catheter that resides in the intrathecal space. The drug is administered slowly through the catheter from a reservoir in the pump. The reservoir is periodically refilled by injecting a supply of the drug through a port located under the skin.

The problem arises because some models of this device have two ports. The first port refills the reservoir and the second one, which is used for myelography or removing CSF, leads directly into the catheter. These accidents occurred when the drug refill, instead of going into the reservoir port, was accidentally injected into the catheter access port. As a result, the drug intended for the reservoir went directly into the intrathecal space, and the patient received a massive overdose.

To help users locate the reservoir port when refilling the pump, the manufacturer provides a template. There's a different template that's used to find the catheter access port. ISMP points out that if this template is mistakenly used to try to locate the reservoir, the medication could be injected directly into the catheter, and then into the intrathecal space.

If you use implanted infusion pumps, or if any of your patients have them, please go to our web site and read the ISMP's article. It has a number of recommendations to prevent this kind of accident. By the way, one of the simplest recommendations is to implant pumps that have only one port, when this is appropriate for the patient.

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 New from FDA

April2004FDA Patient Safety News Homepage
FDA Campaign on Safe Use of Analgesics and Antipyretics (Video, print, and e-mail functions)
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The FDA has launched a nationwide campaign to educate consumers about using analgesics and antipyretics safely. FDA's chief concerns are the potential hepatoxicity associated with acetaminophen, and the GI bleeding and renal toxicity associated with NSAIDs. Although these risks are rare, they're largely preventable. And so FDA's campaign is designed to increase the public's awareness of the potential risks and how to minimize them.

For example, consumers who take several OTC cold and pain remedies that contain acetaminophen may unknowingly exceed the recommended dose. To add to the problem, prescription drugs containing acetaminophen may not be labeled with that information, and this can lead to the patient taking an even larger dose.

Also, people may not be aware that having more than three alcoholic drinks a day can increase the risks associated with both acetaminophen and NSAIDs.

And children can receive improper dosages if they're given the adult dose, or the wrong formulation of the drug, or if the pediatric dose based on weight is calculated incorrectly.

Check our web site for more information on the campaign, and on what to tell patients about how to use these drugs safely. You can also get educational brochures to give your patients, and reprints of an article for consumers on using caution with pain relievers.

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