 This is FDA Patient Safety News. In this edition, two new drugs to treat metastatic colorectal cancer, more information on antidepressants and suicidality, a recall of certain patient lifts, and teaching patients to use epinephrine injectors. These stories and more on this edition of FDA Patient Safety News. Welcome to the program. For the U.S. Food and Drug Administration, I'm Mark Barnett. And I'm Anita Reiner. Let's start with some medical products FDA recently approved. FDA recently approved two new drugs to treat metastatic colorectal cancer. One of them is Avastin or Bevacizumab, manufactured by Genentech Incorporated, and the other is Herbitux or Satuxumab, manufactured by Imclone Systems Incorporated. Both of these drugs are monoclonal antibodies given intravenously, but they work by targeting different proteins. Avastin, an angiogenesis inhibitor, binds to VEGF, or Vascular Endothelial Growth Factor, which stimulates the formation of new blood vessels. It's believed that once it's bound, the VEGF is no longer able to stimulate new vessel formation, and this can delay tumor growth. Herbitux binds to Epidermal Growth Factor Receptor, or EGFR, a protein that plays a role in regulating cell growth. It's believed that when Herbitux is bound to the receptor, this blocks the Epidermal Growth Factor from binding to the cancer cells, thus blocking their growth. These two drugs are used as part of different treatment regimens and at different stages of treatment. Avastin is given as initial treatment for metastatic colon cancer in combination with the standard three-drug IFL treatment. Herbitux is given to patients whose tumors are no longer responding to standard treatment. It's used with ironotacan, or if patients can't tolerate ironotacan, it's used alone. In a clinical trial, patients with metastatic colorectal cancer who were treated with Avastin in combination with IFL survived about five months longer than control patients who were receiving IFL alone. Although treatment with Herbitux has not yet been shown to increase patient survival, it did delay tumor growth, especially when used as a combination treatment. Treatment with these drugs can cause a range of side effects, some of them serious. For example, rare but serious side effects with Avastin include gastrointestinal perforation, impaired wound healing, hemoptysis, and internal bleeding. Herbitux can also cause serious side effects, usually during infusion of the first dose. These can include airway obstruction and hypotension. FDA recently approved a miniaturized ventricular assist device for children ages 5 to 16 who are awaiting a heart transplant. The device, which is called the DeBakey VAD Child and manufactured by Micromet technology, may allow children with severe left ventricular failure to survive long enough to receive the transplant. While similar ventricular assist devices have been approved for use in adults, this is the first one for children. It was approved under what's called a Special Humanitarian Device Exemption, a mechanism through which FDA can make certain devices quickly available on a limited basis for patients with rare medical conditions. It's estimated that fewer than 100 children per year will be candidates for the new device. In a previous edition of FDA Patient Safety News, we told you about FDA's ongoing review of a possible increased risk of suicidal thinking and suicide attempts in pediatric patients being treated with various antidepressants. Although this review is still underway, FDA has now sent a new advisory to healthcare professionals. The advisory describes new warnings about the need to closely observe both children and adults on antidepressants. The trade names of the drugs that are the focus of this labeling change are Prozac, Zoloft, Paxil, Luvox, Selexa, Lexapro, Wellbutrin, Afexer, Surzone, and Remeron. The advisory says to carefully monitor patients on these drugs for possible worsening depression or emergent suicidality, and this is especially important at the beginning of treatment or when the dose is either increased or decreased. Now, does that mean that the FDA believes that taking these drugs can cause an increased risk of suicidality? No, a causal link hasn't been established between these drugs and suicidality. Suicidal thoughts and attempts in these patients could be due to the underlying disease condition or might be due to the drug. Now, I'm assuming that a patient whose first experience with suicidal thoughts occurs after starting on one of these drugs would be a prime candidate for monitoring. Yes, they would be, but there are other groups that should also be evaluated to determine whether their drug therapy should be discontinued or perhaps modified in some way. For example, patients whose depression becomes persistently worse or whose suicidality is severe or abrupt in onset. The advisory also points out that patients should be observed for anxiety, agitation, panic attacks, and other behavioral symptoms known to be associated with antidepressant therapy. Although FDA hasn't concluded that these symptoms are a precursor to worsening depression or suicidal impulses, patients who experience these symptoms may be at increased risk. Again, therapy should be evaluated and medications may need to be stopped in patients with symptoms that are severe, abrupt in onset, or weren't part of the patients presenting symptoms. Now, everything you said so far about monitoring the patient has to do with the practitioner. But with these drugs, I'm assuming the patient has a role to play too in monitoring how they're feeling. Absolutely. Patients have a role and family members have a role. Remember, many of these patients are children, so parents can play a very important part. In any case, patients, family members, and caregivers should be told to look for these kinds of symptoms or suicidal thoughts and report them immediately to healthcare providers. You can get a copy of FDA's full advisory on our website. FDA recently announced that certain battery operated patient lifts are being recalled by their distributor because they can break during use and endanger patients. The lift in question is called the FABORG person lift. It's manufactured in Denmark and distributed in the U.S. by Moving Solutions. Over 800 of these lifts have been sold in this country. The problem occurs when the bolt that secures the lift arm to the main frame breaks. This can cause the patient to fall and possibly cause the lift arm to fall on the patient as well. One death has been reported because of this failure in the bolt. In January, Moving Solutions notified users of the problem, and they included a nylon washer to be inserted over the bolt. At this point, FDA is investigating whether the washer is going to correct the problem. In the meantime, FDA is advising all facilities that have FABORG battery operated person lifts to stop using them. Major pharmaceuticals, a drug distributor, is recalling certain lots of the company's OTC nasal decongestant. Some of the recalled lots are contaminated with Burkholderia sapatia, which could cause potentially life-threatening infections when used by patients with compromised immune systems, particularly those with cystic fibrosis. The recalled spray is sold over the counter in 15 and 30 milliliter bottles. The label says major soothing twice a day 12-hour nasal spray decongestant, regular oxymetazoline hydrochloride 0.05%, distributed by major pharmaceuticals, LaVonia, Michigan. Ten lots of this product are currently being recalled. If you stock this product or have patients who use it, go to our website to find the lot numbers that were recalled. Check this information against the lot number found on the bottom of the carton and on the back of the bottle label. You can find additional information and instructions on how to return the recalled product on our website. Now a warning about the drug Zyprexa, or Olanzapine, made by Eli Lillian Company. Zyprexa is used to treat schizophrenia and bipolar disorder. The warning section of the drug's label now describes cerebrovascular adverse events. These have occurred in elderly patients being treated for dementia-related psychosis in clinical trials. These events, some of them fatal, have included stroke and TIAs. The labeling reminds practitioners that Zyprexa has not been approved for the treatment of patients with dementia-related psychosis. FDA has issued a public health notification reminding surgeons that absorbable hemostatic agents can cause neurological damage if they're applied on or near a bony or neural space and left in the patient. Since 1996, FDA has received more than 100 reports of adverse events with absorbable hemostatic agents, 11 of which resulted in paralysis or neural deficits. Mark, what's the connection between using one of these hemostatic agents and paralysis? Well, the common thread in all of those 11 cases was that the absorbable hemostatic agent was applied on or near a bony or neural space and it was left in the patient. Once it was wet, the material swelled and then it exerted pressure on the spinal cord or other neural structures. In some cases, blood pooled behind the material and formed a hematoma that exerted pressure on neural tissue. Now, you said 11 reports of neurological damage and that's not that large a number considering how often these products are used. Well, that's right. These are rare events, but they have grave consequences and the most important thing is that they're largely preventable. Hemostatic agent recommends two specific steps to reduce the risk. First, when you're using an absorbable hemostatic agent on or near bony or neural spaces, use only the minimum amount necessary to achieve hemostasis. And second, remove as much of the material as possible after hemostasis is achieved. Recent articles have warned health professionals about dangerous mix-ups between opium tincture and paragoric. Since 1997, FDA has received eight reports of medication errors involving these two drugs. Three of them were fatal and three others required medical treatment. The danger stems from the fact that opium tincture is 25 times more concentrated than paragoric. So if the practitioner thinks that he or she is ordering paragoric but is actually ordering opium tincture, the patient could receive a large overdose. Well, how can a person be thinking paragoric when they end up ordering opium tincture? The names certainly don't sound alike. Those names don't sound alike, but the key is that each one of them has synonyms, and it's the synonyms that can sound alike and be confusing. Opium tincture, for example, is also called deodorized opium tincture, deodorized tincture of opium, tincture of opium, lotinum, opium, and DTO, which is an abbreviation for deodorized tincture of opium. Paragoric is also called camphorated tincture of opium and tincture of paragoric. So you can see how this confusion of names can lead to errors. For example, some practitioners have prescribed DTO thinking that this abbreviation stands for diluted tincture of opium. What it actually means, deodorized tincture of opium, and as a result, patients have been seriously overdosed. So what's the answer to all this confusion? Well, the main answer is that FDA is going to be working with manufacturers to clarify the labeling to clear up the confusion. In the meantime, it's really important to educate practitioners and staff members to avoid this kind of confusion. One general rule of thumb that can help to prevent errors is to remember that opium tincture is dosed in drops, in other words, in fractions of a milliliter, whereas paragoric is dosed in teaspoons. So any order for opium tincture that specifies teaspoonful doses is likely to be an error. Our website lists a number of additional recommendations to avoid mix-ups between paragoric and opium tincture that hospital pharmacies might want to consider. Millions of people have severe allergies to food, insect venom, drugs, latex, or other allergens. Many of these patients are given epinephrine autoinjectors, such as EpiPen, to use when an anaphylactic reaction occurs. But patients may not always be well-trained on how to use these devices, right? They may not remember what to do in an emergency. So here's a quick, step-by-step review of how to use one widely prescribed brand of injectable epinephrine, the EpiPen, distributed by day. You may want to pass this information onto your patients with severe allergies. Remove the EpiPen from its amber tube. Grasp it with the thumb towards the gray activation cap, but not over it. Remove the cap. Be sure not to touch the black tip at the other end of the EpiPen when it's removed. Hold the autoinjector with the black tip towards the outer thigh. Swing and jab firmly at a 90-degree angle into the outer thigh. Keep it against the thigh for 5 to 10 seconds. Remove the EpiPen and massage the injection site for several seconds. Look at the tip to be sure the needle is visible, and check the small clear window on the EpiPen for the black plunger, indicating that the epinephrine is affected. After using EpiPen, press the needle against a hard surface to bend it back towards the shaft. Then return it to the amber tube. Call 911 and go to an emergency room as soon as possible. Patients should take the used EpiPen with them to the hospital and give it to the physician for inspection and for proper disposal. Go to our website for more information. That's all for this edition of FDA Patient Safety News. Remember, you can get more information on all the stories you've seen here today by visiting our website. We also urge you to use the website to report problems you've encountered with medical products. That's how we learn about problems so we can alert others. We'll be back next month with another edition, so watch for us. Until then, for the U.S. Food and Drug Administration, I'm Anita Reiner. And I'm Mark Barnett. See you next time.