FDA Patient Safety News: Show #73, March 2008
First Drug to Treat PKU Approved FDA has approved the first drug to treat phenylketonuria (PKU), which is a genetic disorder that affects one in about 15 thousand births in the U.S. The drug, called Kuvan (sapropterin dihydrochloride) was developed by BioMarin Pharmaceutical in partnership with Merck. Additional Information: FDA Press Release. FDA Approves Kuvan for Treatment of Phenylketonuria (PKU). December 13, 2007. Recall of Heparin and Saline Flush Syringes Here is an alert about a nationwide recall of all heparin and normal saline flushes manufactured by AM2 PAT, Inc. These pre-filled syringes are distributed under two brand names: Sierra Pre-filled and B. Braun. Additional Information: FDA Press Release. FDA Warns Public of Contaminated Syringes. January 25, 2008. Recall of Heparin and Saline Flush Syringes Here is an alert about a nationwide recall of all heparin and normal saline flushes manufactured by AM2 PAT, Inc. These pre-filled syringes are distributed under two brand names: Sierra Pre-filled and B. Braun. Additional Information: FDA MedWatch Safety Alert. Heparin and Normal Saline Pre-Filled Flushes. January 18, 2008. Recall of Heparin and Saline Flush Syringes Here is an alert about a nationwide recall of all heparin and normal saline flushes manufactured by AM2 PAT, Inc. These pre-filled syringes are distributed under two brand names: Sierra Pre-filled and B. Braun. Additional Information: FDA MedWatch Safety Alert. Heparin Lock Flush Solution (Pre-Filled 5 ml in 12 ml Syringes). December 21, 2007. Severe Pain with Osteoporosis Drugs FDA is alerting healthcare professionals that severe bone, joint, or muscle pain can occur in patients taking bisphosphonate drugs such as Fosamax (alendronate sodium), Actonel (risedronate sodium), Reclast (zoledronic acid) and Boniva (ibandronate sodium). These drugs are used to treat osteoporosis and certain other diseases. Additional Information: FDA MedWatch Safety Alert. Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa). January 7, 2007. Warning on Exjade and Liver Failure Novartis is warning healthcare professionals that hepatic failure can occur in patients treated with Exjade(deferasirox). Exjade is used to treat tranfusional hemosiderosis, the chronic iron overload that can result from multiple blood transfusions. Additional Information: FDA MedWatch Safety Alert. Exjade (deferasirox) Tablets For Oral Suspension. December 13, 2007. Dangerous Skin Reactions from Carbamazepine FDA is alerting healthcare professionals about dangerous and possibly fatal skin reactions to the drug carbamazepine in certain patient populations. The reactions have included Stevens Johnson syndrome and toxic epidermal necrolysis. Additional Information: FDA MedWatch Safety Alert. Carbamazepine (marketed as Carbatrol, Equetro, Tegretol and generics). December 12, 2007. Potentially Fatal Hyponatremia from Desmopressin FDA is notifying healthcare professionals about the risk of potentially fatal hyponatremia in certain patients treated with desmopressin, an antidiuretic that is sometimes used to treat nocturnal enuresis (bedwetting). It works by reducing water loss in the urine. Additional Information: FDA MedWatch Safety Alert. Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray). December 4, 2007. Alaris (Medley) Infusion Pumps Recalled Cardinal Health is recalling all Alaris Infusion Pump modules shipped before September 27, 2007. The products, which are Model 8100, were formerly known as Medley Pump modules. Additional Information: FDA MedWatch Safety Alert. Cardinal Health Alaris Pump Module. December 26, 2007. Alaris (Medley) Infusion Pumps Recalled Cardinal Health is recalling all Alaris Infusion Pump modules shipped before September 27, 2007. The products, which are Model 8100, were formerly known as Medley Pump modules. Additional Information: Cardinal Health. Alaris Pump Voluntary Recall Update. December 27, 2008. Preventing Burns from Electric Dental Handpieces FDA is warning dental professionals about serious patient injuries caused by poorly maintained electric dental handpieces. Some patients have experienced third degree burns that needed plastic surgery. The burns have occurred during tooth extraction, when cutting teeth and bone, and during other surgical procedures, but overheating could happen during any dental procedure. Additional Information: FDA MedWatch Safety Alert. Electric Dental Handpieces. December 13, 2007. MedWatch: Reporting Adverse Events FDA's Medwatch program allows health care professionals and consumers to report to the FDA serious problems with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns. Additional Information: MedWatch - The FDA Safety Information and Adverse Event Reporting System.
Those with PKU cannot metabolize phenylalanine, which is an amino acid found naturally in many foods. Normally, phenylalanine metabolism is controlled by the enzyme phenylalanine hydroxylase. In PKU patients, this enzyme does not function properly. That causes high blood levels of phenylalanine, which can lead to mental retardation, behavioral abnormalities, seizures and other neurological complications.
Kuvan increases the activity of phenylalanine hydroxylase in those PKU patients who have some residual functioning of this enzyme. This leads to improved breakdown and lower blood levels of phenylalanine. Still, in order for the drug to be most effective, patients on Kuvan must be on a phenylalanine-restricted diet, and blood levels must be monitored frequently.
The safety and efficacy of Kuvan was demonstrated in four short-term studies of 579 PKU patients. In addition, the manufacturer will establish general disease registries for PKU to help track clinical results and monitor any adverse effects.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109039.htm
Some of the syringes have been found to be contaminated with Serratia marcescens, which has caused patient infections that can be serious and even fatal.
All sizes and strengths of these heparin and saline flushes are being recalled. If you have any of these syringes, stop using them immediately. Quarantine them and return them to your distributor. For questions, contact the company at 919-552-9689.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116846.htm
Some of the syringes have been found to be contaminated with Serratia marcescens, which has caused patient infections that can be serious and even fatal.
All sizes and strengths of these heparin and saline flushes are being recalled. If you have any of these syringes, stop using them immediately. Quarantine them and return them to your distributor. For questions, contact the company at 919-552-9689.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm078971.htm
Some of the syringes have been found to be contaminated with Serratia marcescens, which has caused patient infections that can be serious and even fatal.
All sizes and strengths of these heparin and saline flushes are being recalled. If you have any of these syringes, stop using them immediately. Quarantine them and return them to your distributor. For questions, contact the company at 919-552-9689.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152467.htm
This severe, sometimes incapacitating musculoskeletal pain has occurred within days, months, or even years after starting bisphosphonates. In the most serious cases, the pain was so severe that patients could not continue their normal activities. Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution.
Note that these events are different from the acute phase response some patients experience after the first treatment with IV bisphosphonates, and occasionally after the first dose of oral bisphosphonates.
Although severe musculoskeletal pain is described in the labeling for all bisphosphonates, this association may be overlooked by practitioners because they may assume that the patient's pain can be attributed to osteoporosis itself.
Practitioners should consider whether musculoskeletal pain in patients on bisphosphonates might be caused by the drug, and consider discontinuing it either temporarily or permanently.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150837.htm
Cases of liver failure, some of them fatal, have been reported in patients treated with Exjade. Most of these cases occurred in patients over 55 years old who had significant comorbidities, including liver cirrhosis and multi-organ failure.
Because of this, liver function should be monitored monthly, and if there is unexplained, persistent, or progressive increase in serum transaminase levels, Exjade treatment should be modified or interrupted.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152285.htm
Carbamazepine is an anticonvulsant used to treat epilepsy, as well as mania/bipolar disorder and neuropathic pain. This drug is sold under the trade names Carbatrol, Equetro and Tegretol, and also as a generic.
These skin reactions are significantly more common in patients with a particular human leukocyte antigen allele called HLA-B*1502. This allele occurs almost exclusively in people with Asian ancestry, including South Asian Indians. Patients with this ancestry should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine, using available genetic tests.
If test results are positive, the drug should not be started unless the expected benefit clearly outweighs the risk of serious skin reactions.
Patients who test positive for HLA-B*1502 may also be at increased risk from other antiepileptic drugs that have caused serious skin reactions. So clinicians should consider avoiding these drugs when other treatments are equally acceptable.
Patients who test negative for HLA-B*1502 have a low risk of developing serious skin reactions from carbamazepine, but these reactions can still occur, although rarely. So healthcare professionals should watch for symptoms in any patient taking this drug.
But note that over 90 percent of all serious skin reactions do occur within the first few months of treatment. This means that patients who have been on the drug for longer periods of time without developing skin reactions have a low risk of this kind of reaction in the future. And that includes even those who test positive for HLA-B*1502.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#carbamazepine
FDA has reviewed 61 reports of hyponatremic seizures associated with the use of desmopressin. Twenty-five cases occurred in children taking the drug intranasally, most of them for bedwetting. Because of this, the intranasal form of desmopressin is no longer indicated for treating nocturnal enuresis. It should not be used for any indication in hyponatremic patients or those with a history of hyponatremia.
Patients taking desmopressin who consume excessive fluids are at higher risk of developing hyponatremia. And so all forms of desmopressin should be used cautiously in patients with polydipsia and in patients taking drugs that may cause increased fluid intake. When using desmopressin tablets, fluid intake should be restricted starting one hour before taking the drug and continuing for 8 hours afterwards.
Interrupt treatment for nocturnal enuresis if the patient significantly increases water intake, or when fluid or electrolyte imbalance are apt to occur, as with fever, recurrent vomiting, diarrhea or vigorous exercise.
Patients or their caregivers should watch for circumstances that could lead to excessive fluid intake, again such as fever, vomiting, diarrhea and strenuous exercise, but also during hot weather and when taking certain medications that produce dry mouth. They should contact their doctor if symptoms of hyponatremia occur, such as severe headache, confusion, nausea, vomiting, fatigue, muscle cramps or weakness.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Desmopressin
The company recalled these units after receiving reports of inaccurate flow rates. The problem is that the occluder springs, which control medication flow, may have been misassembled during manufacturing or servicing. Misassembled springs can lead to overinfusion, which could result in serious health consequences or death.
The company says that overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there's no warning or notification when an overinfusion does occur.
Cardinal Health plans to inspect all of the recalled units and repair those with misassembled springs. Until this process is completed, the company is recommending that facilities perform an occluder pressure test on their Alaris pump modules using the method outlined in updated Service Bulletin 528A. A unit that fails this test should be taken out of service. However, since the test may not be able to detect all misassembled springs, the company will still need to inspect all of the recalled units.
For more information, contact the Alaris Pump Module Call Center at 800-625-6627.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152425.htm
The company recalled these units after receiving reports of inaccurate flow rates. The problem is that the occluder springs, which control medication flow, may have been misassembled during manufacturing or servicing. Misassembled springs can lead to overinfusion, which could result in serious health consequences or death.
The company says that overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there's no warning or notification when an overinfusion does occur.
Cardinal Health plans to inspect all of the recalled units and repair those with misassembled springs. Until this process is completed, the company is recommending that facilities perform an occluder pressure test on their Alaris pump modules using the method outlined in updated Service Bulletin 528A. A unit that fails this test should be taken out of service. However, since the test may not be able to detect all misassembled springs, the company will still need to inspect all of the recalled units.
For more information, contact the Alaris Pump Module Call Center at 800-625-6627.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152425.htm
The problem occurs if an electric handpiece is worn or clogged. In that case, the motor sends increased power to the handpiece head to maintain performance, which generates heat at the head or the attachment. All of this can happen very quickly. And it can happen without warning, because the patient is anesthetized so he or she can't feel the burn and the operator is protected from the heat by the handpiece housing.
Burns are less likely to occur with air-driven handpieces, because if there is a problem such as worn gears or a dull bur, the handpiece will perform sluggishly, and this alerts the operator to get it looked at.
Here's what's FDA recommends to prevent burns from electric handpieces. Essentially, it boils down to assuring proper maintenance. For example:
• Maintain the handpiece according to the manufacturer's instructions, and verify how often the device should be serviced.
• Be sure that personnel are trained to clean and maintain the device, and that they track and record this.
• Examine the handpiece before you use it, and be sure you're not using a worn drill or bur.
• Finally, it's also important to understand that the problem of burns from electric handpieces occurs outside the dental area. Similar devices are used in orthopedics, ENT procedures and podiatry, and any of these devices can also cause burns.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152462.htm
It is important to keep the MedWatch system working, and we can not do that without your help. Here are the kinds of reports we need from you:
• Report any serious adverse event that might be associated with a drug, biologic, medical device, or dietary supplement. By "serious" we mean fatalities, hospitalizations, and medically significant events. FDA is especially interested in serious adverse events that aren't listed in the product labeling.
• Report therapeutic failures - cases 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).
• Report cases of 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.
• Report product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging.
FDA encourages you 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.
http://www.fda.gov/medwatch/
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