FDA's MedWatch Safety Alerts: August 2012

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After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.
FDA encourages health care professionals and consumers to report problems with medical products, including

unexpected and undesirable side effects
quality problems, such as a drug with an unusual odor or color, or a device with defective parts
unclear or confusing instructions
failure to deliver the expected benefit.

Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

Online
Regular Mail: Use postage-paid, pre-addressed FDA form 3500 (http://www.fda.gov/medwatch/report.htm)
Fax: 800-FDA-0178
Phone: 800-332-1088

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness, or death.
Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.
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Caution Urged in Giving Kids Codeine

FDA is reviewing reports of children who developed serious side effects or died after taking codeine for pain relief after surgery for the removal of tonsils or adenoids to treat sleep apnea. Three deaths and one non-fatal but life-threatening case of respiratory depression (slower breathing) were documented in medical literature.
Risk: These children, ages 2 to 5, had an inherited ability to convert codeine into life-threatening or fatal amounts of morphine in the body. Codeine is converted to morphine in the body by a particular enzyme. Some people have variations in their DNA that cause this conversion to be faster and more complete, making the morphine levels high. High levels of morphine can lead to potentially fatal breathing difficulties.
Recommendations
Health care professionals should be aware of the risks of using codeine in children, particularly in those who have undergone surgery to treat sleep apnea.

If codeine is prescribed, the lowest effective dose for the shortest period of time should be used on an as-needed basis—not around the clock.
Parents and caregivers who observe unusual sleepiness, confusion, or difficult or noisy breathing in their child should seek medical attention immediately. These are signs of overdose.

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Safety Concerns Raised About Defibrillator Leads

FDA is making recommendations regarding safety concerns with the recalled Riata and Riata ST leads that connect implantable cardioverter defibrillators (ICDs) to the heart to monitor heart rhythms. ICDs can detect life-threatening heart rhythms and deliver an electrical shock through the lead to the heart. These leads have an increased risk that the layers of insulation that protect electrical conductor wires will prematurely fail, affecting their ability to function properly.
Risk: Riata’s manufacturer, St. Jude Medical Inc., recalled these leads on Nov. 28, 2011, because of premature erosion of the insulation around the electrical conductor wires. St. Jude Medical stopped selling these leads in late 2010 but reports that as of 2011, about 79,000 Riata leads remained implanted in patients in the United States.
If an ICD lead isn’t working properly, there could be defects in its ability to detect a problem or deliver shock therapy, which could result in serious injuries or death.
Recommendations

Patients should contact their cardiac physician to determine if they have the recalled leads and to request additional information regarding care and monitoring. Physicians and patients should discuss the best approach to take based on individual need.
Physicians should closely monitor patients who have a Riata or Riata ST lead and notify patients if they have a recalled lead.
Patients with these leads should be evaluated with X-rays or other imaging technology for the presence of any electrical abnormalities.
St. Jude Medical recommends reprogramming the device to increase the chance for detection of a lead abnormality.

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FDA: Revatio Not for Children

FDA is advising healthcare professionals and medical organizations that the drug Revatio (sildenafil) should not be prescribed for children ages 1-17 for treatment of pulmonary arterial hypertension (PAH). Treatment of PAH in children with this drug is an off-label use (a use not approved by FDA), and a new warning that use is not recommended in pediatric patients has been added to the Revatio labeling.
Risk: A recent clinical pediatric trial showed that:

Children taking a high dose of Revatio had a higher risk of death than children taking a low dose.
The low doses of Revatio are not effective in improving exercise ability.

Revatio relaxes blood vessels in the lungs to reduce blood pressure and is approved to improve exercise ability and delay clinical worsening of PAH in adult patients.
Recommendations

Patients and caregivers are advised to not change the dose or stop taking Revatio without talking to a healthcare professional.
Healthcare professionals were reminded that use of this product, particularly chronic use, in children is not approved by FDA, and is not recommended.

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Drug Safety Communication

Reumofan Products Pose Health Risk

FDA has issued an updated alert that Reumofan Plus and Reumofan Plus Premium—marketed as dietary supplements for treatment of arthritis, muscle pain, osteoporosis, bone cancer and other conditions—have hidden drug ingredients that can cause serious and potentially fatal side effects
Risk: Since June 1, 2012, when FDA first warned the public about the dangers of these supplements, the agency has received reports of fatalities, stroke, severe bleeding in the gastrointestinal tract (including the esophagus, stomach and intestines), dizziness, insomnia (difficulty sleeping), high blood sugar levels and problems with liver and kidney functions, as well as corticosteroid withdrawal syndrome.
FDA analyzed the products and found the following drug ingredients:

diclofenac sodium—a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events, such as heart attack, as well as serious gastrointestinal problems.
methocarbamol—a prescription muscle relaxant that can cause sedation, dizziness and low blood pressure.
dexamethasone— a corticosteroid that can increase the risk of infection and cause increased blood sugar levels, changes in blood pressure, damage to bones, psychiatric problems and adrenal suppression.

Recommendations

Consumers should not start buying or using these products.
Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately, because a person who stops taking corticosteroids after long-term use, or after taking high doses, runs the risk of suffering from withdrawal syndrome. Individuals must work with their healthcare professionals to slowly and safely taper off the drug.

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Stent System’s Uses Narrowed

FDA is informing consumers and health care professionals that the indications and labeling for Stryker’s Wingspan Stent System (Wingspan) have been changed to limit its use to a narrow, select group of patients and conditions.
Wingspan is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis who are experiencing repeated strokes, preventing more strokes from occurring. Stenosis, or narrowing of the arteries, is a serious condition caused by a buildup of plaque, or fatty deposits, within the arteries.
Risk: Wingspan may present unacceptable risks, such as stroke and death, to many patients previously considered appropriate for treatment.
It should not be used for:

the treatment of stroke with an onset of symptoms within seven days or less of treatment; or
the treatment of transient ischemic attacks (mini strokes).

After reviewing the available safety information, the agency believes that a very specific group of patients may benefit from using the device because they are at serious risk of life-threatening stroke and have limited alternative treatment options. They are patients:

between 22 and 80 years old AND who have had two or more strokes despite aggressive treatment;
whose most recent stroke occurred more than seven days prior to planned treatment with Wingspan;
who have 70-99 percent stenosis due to plaque buildup in the intracranial artery related to the recurrent strokes; and
who have made good recovery from previous strokes and have a modified Rankin score of 3 or less prior to Wingspan treatment.

The Rankin scale is used to measure the degree of disability in stroke patients. Lower scores indicate less disability.
Recommendations
Ask your health care professional if there are other options available to you before considering Wingspan. If a health care professional recommends interventional treatment for intracranial stenosis, talk to him/her about:

whether you are a good candidate for treatment with Wingspan;
risks and benefits associated with the use of Wingspan; and
problems that can occur with the use of Wingspan, and additional medical procedures that may be needed to treat these problems.

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• Safety Communication
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Recall: Dukal Antiseptic Swabs and Wipes

Dukal Corporation announced a U.S. voluntary nationwide recall of selected lots of benzalkonium chloride swabs and antiseptic wipes manufactured for Dukal by Jianerkang Medical Dressing Co. due to concerns about potential contamination with the microbe Burkholderia cepacia.
Benzalkonium chloride antiseptic wipes are sold separately over the counter and in kits. They were distributed nationwide to the wholesale and retail levels.
Risk: Use of contaminated wipes could lead to infections, some of which pose health risks in people with suppressed immune systems.
Recommendations

Discontinue use and dispose of products identified in this recall immediately. See the press release below for a listing of lot numbers affected.
For more information, call the customer support team Monday to Friday from 8:30 am to 5:30 pm Eastern time at 800-243-0741 or e-mail productsupport@dukal.com.

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Press Release

Drug Safety Labeling Changes

In July 2012, FDA required safety labeling changes to be made to 41 drug products, including 12 opioid medications such as Oxycontin. The labels were updated to include information on the potential for abuse of these powerful, narcotic medications and the risk of life-threatening respiratory depression. There is also information on safe use and disposal.
In general, changes were made to the prescribing information and, in some cases, to the patient package inserts and medication guides (paper handouts for patients that come with many prescription medicines) to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.
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