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U.S. Department of Health and Human Services

Show #21, November 2003

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Show #21, November 2003

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 New Medical Products

November2003FDA Patient Safety News Homepage
New Stair-Climbing Wheelchair (Video, print, and e-mail functions)
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FDA has approved a new powered wheelchair that can climb stairs, go up and down curbs, and operate on gravel, grass, and sand. It can also raise itself up, so that the seated user can have an eye-level conversation with a standing person, or can reach high shelves. It's called the INDEPENDENCE iBOT 3000 Mobility System, and it's manufactured by Independence Technology. It works using a computerized system of sensors, gyroscopes and electric motors.

Although other devices have some of these features, like elevating the user, the iBOT 3000 can do three things: climb curbs and stairs, elevate the user, and travel over uneven ground.

Not everyone can use one of these chairs. Users must have the use of at least one hand to operate the controls on the chair, they can't weigh more than 250 pounds, and they can't have medical conditions that increase their risk of bone fractures. They also must be able to sit upright and bend their knees so they can use standard footrests. And they must have the judgment to avoid obstacles that could cause a fall. In fact, patients have to be trained in using the chair, and pass a test to prove they can operate it safely. And health professionals have to undergo special training to prescribe the chair.

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New Drug for Alpha -1 Protease Inhibitor Deficiency (Video, print, and e-mail functions)
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FDA recently approved a new drug called Zemaira for people with a deficiency of Alpha 1-Proteinase Inhibitor who also have evidence of emphysema. Alpha 1-Proteinase Inhibitor, also called Alpha 1-PI or Alpha-1 antitrypsin, is a blood protein that protects tissues from being digested by enzymes released during the inflammation process. Zemaira, made by Aventis Behring L.L.C., is highly purified human alpha 1-PI derived from human plasma. It's administered intravenously.

A deficiency of Alpha-1-PI shows up most frequently as lung disease, although it can also affect the liver. It’s generally thought to be very rare, but some evidence suggests that about 1 in 3,000 individuals in the U.S. may have this deficiency. Most affected people are not aware of their condition.

Although there are other treatments for this condition already on the market, the availability of this new product offers more choice and provides further safeguards against any possible disruption in the supply of these treatments.

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 Recalls and Safety Alerts

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Warning on Salmeterol for Asthma (Video, print, and e-mail functions)
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GlaxoSmithKline has added a new boxed warning and other safety information to the labeling for several drugs containing salmeterol, a long-acting bronchodilator used to treat asthma and chronic obstructive pulmonary disease. Those drugs include Serevent Inhalation Aerosol, Serevent Diskus, and Advair Diskus. The new warning describes a small but significant increase in the risk of life-threatening asthma episodes or asthma-related deaths in patients taking salmeterol.

The new information comes from the so-called SMART study, a large placebo-controlled U.S. investigation of Serevent. The study was designed to further investigate the safety of Serevent, particularly whether it might cause rare, but serious asthma-related adverse events. The trial compared the effects of adding salmeterol vs. a placebo to a patient's usual asthma therapy over 28 weeks.

FDA and GlaxoSmithKline have analyzed the data, which includes about 13,000 patients each in the Serevent group and the control group. There were 13 asthma-related deaths in the Serevent group, vs. 4 in the control group. Subgroup analyses suggest that the risk may be greater in African-American patients than Caucasians.

FDA is emphasizing that the benefits of treating asthma and COPD with salmeterol products continue to outweigh the potential risks when these drugs are used according to the instructions in the labeling. Patients should NOT discontinue treatment with Serevent or Advair products without consulting with their physician, because abruptly stopping these drugs can result in acutely deteriorating asthma control, which could be life-threatening. FDA points out that all asthma drugs, including salmeterol, should be prescribed as part of a comprehensive plan that takes into account the severity of the patient's asthma and educates the patient about the disease and how it's treated.

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Alert on IMOVAX Rabies Vaccine (Video, print, and e-mail functions)
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Here's an alert about the rabies vaccine, IMOVAX. The manufacturer, Aventis Pasteur, says that some of their old packages of IMOVAX are missing the vials of freeze-dried vaccine and contain only a diluent syringe and two needles. Each box should include a vial of freeze-dried vaccine plus a diluent syringe and the two needles.

If you stock this product in the older packages, which are gray boxes, Aventis Pasteur says you should open every box in your inventory to confirm that it contains the vaccine vial. If you find a package where it's missing, contact the company.

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Warning on Human Growth Hormone for Prader-Willi Syndrome (Video, print, and e-mail functions)
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Pharmacia & Upjohn Company, a subsidiary of Pfizer Inc, has issued a letter to health care professionals alerting them to important new safety information about their growth hormone product, Genotropin, when it's used to treat children with growth failure due to Prader-Willi syndrome.

Prader-Willi is a congenital disorder characterized by short stature, mental retardation, excessive eating, obesity, and sexual infantilism. Genotropin is used in Prader-Willi patients to increase stature and improve the ratio of lean to fat tissue.

The company has issued the alert because it has become aware of seven fatalities worldwide in children being treated with Genotropin for Prader-Willi syndrome.

The affected children shared several risk factors: severe obesity, a history of respiratory impairment or sleep apnea, or an unidentified respiratory infection. Male patients with one or more of these risk factors may be at greater risk than females.

The package insert now states that growth hormone is contraindicated in Prader-Willi patients who are severely obese or who have severe respiratory impairment. The warnings go on to say that patients should be evaluated for upper airway obstruction before beginning treatment with growth hormone, and that the treatment should be interrupted if patients show signs of upper airway obstruction. For additional information, you can contact Pfizer Medical Information at 800-323-4204.

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Warning for Risperdal (Video, print, and e-mail functions)
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Now a warning about the drug RISPERDAL or risperidone, manufactured by Janssen Pharmaceutica and used to treat schizophrenia. The WARNINGS section of the label for this drug now describes cerebrovascular adverse events in elderly patients being treated for dementia-related psychosis in clinical trials. These events, some of them fatal, included stroke and TIA. The warning goes on to say that RISPERDAL has not been approved for the treatment of patients with dementia-related psychosis.

In a recent letter to practitioners, Janssen Pharmaceutica is offering additional information on these and other clinical trials conducted in elderly patients. Call the company at 1-800-JANSSEN.

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 Preventing Medical Errors

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Drug Name Confusion: Purinethol® & Propylthiouracil (Video, print, and e-mail functions)
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Every now and then we alert you to mix-ups that can occur when drug names look or sound alike. This time we're talking about the similarity between the trade name of one drug and the generic name of another. Purinethol®, is the trade name of a potent antimetabolite used in oncology, whose generic name is mercaptopurine. Propylthiouracil is an anti-thyroid agent available only in generic form.

The Institute for Safe Medication Practices points out that although these drug names appear to be quite distinct, there are several common characteristics that may cause confusion. Both names start with "P" and end with "L", both come in 50 mg. tablets, and the "your" sound in "purine" and "uracil" can increase the risk of error. And propylthiouracil is often abbreviated "PTU", which can be mistaken to mean Purinethol®.

ISMP describes several examples of mix-ups between Purinethol® and propylthiouracil. In one case, a child with acute lymphoblastic leukemia mistakenly received propylthiouracil instead of Purinethol® for 6 months, even after his parents asked why the tablet looked different. No direct harm occurred, but the patient missed 6 months of chemotherapy, which then led to modifications in the therapy.

Perhaps more serious is the reverse kind of error, when Purinethol® is administered instead of propylthiouracil. The dose of propylthiouracil is often several hundred milligrams a day, which could be up to 6 times the maximum dose for Purinethol®. So mistakes where Purinethol® is given at these high doses could lead to significant harm, including bone marrow suppression, hepatotoxicity, immunosuppression, and teratogenicity.

ISMP suggests some ways to help reduce the risk of this kind of mix-up: Separate these two drugs on pharmacy shelves. List both the brand and the generic name on prescriptions for Purinethol®. Avoid using abbreviations. Counsel patients before dispensing these two drugs, and fully investigate situations where they report that their drugs look different than usual.

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Children at Risk from Brightly Colored Pills (Video, print, and e-mail functions)
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In a recent Medication Safety Alert, the Institute for Safe Medication Practices cautions that brightly colored pills could be mistaken for candy by young children. They cite the case of a two-year old brought to the emergency room after ingesting Wellbutrin SR. They note that this product is brightly colored in all three of its strengths, and that, viewed upside down, the drug name and strength that are printed on the tablets that might look like a happy face to a child.

ISMP reiterates the general need to educate parents to use safety caps, to keep medications out of children's reach, and to teach their children about poisons. But they note that this may be especially important with medications that can look to a child like candy.

Speaking of children, the FDA and the Council on Family Health have issued a new brochure that helps parents use over-the-counter medications safely for their kids. It's called "Got a Sick Kid?", and it goes through ten tips for giving the right medicine, in the right amount.
It also provides a chart showing the recommended immunization schedule for children. You can get copies of the brochure from the Council on Family Health by calling 202-331-7373.

And while we're talking about brochures, the FDA has a new one for patients and caregivers who are using medical devices in the home. It's a checklist that helps people use these products safely and effectively. It also provides general tips on maintaining medical devices so they continue to work as they're supposed to, as well as instructions for reporting adverse events. To find out how to get copies, go to our web site.

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 Advice for Patients

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Cell Phones and Hearing Aids (Video, print, and e-mail functions)
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If you have patients or family members who wear hearing aids, you may know that they often have trouble using cell phones. Some cell phones cause radiofrequency interference with hearing aids, so the user hears high-pitched whistling sounds through the hearing aid, or static, or thumping sounds.

But all cell phones aren't alike in this respect. Some of the phones have lower radiofrequency emissions or different technology that can reduce the unwanted effects on hearing aids. So you should advise hearing aid wearers shopping for a cell phone to try several brands and models before they decide. Some hearing aids may be so susceptible to interference that they simply won't work with any of the cell phones available, while others are designed to be resistant to interference. So the same trial and error approach is also important when shopping for hearing aids.

Fortunately, hearing aids are improving and before long it's going to be much easier for hearing aid wearers to find a compatible phone. Also, FDA has begun working with the hearing aid industry on ways to help clinicians and consumers choose hearing aids and cell phones that are likely to work together. The phones will be improving, too. The Federal Communications Commission recently announced that they'll require cell phone manufacturers to make at least some models usable by hearing aid wearers within the next two years.

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FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.

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