FDA’s MedWatch Safety Alerts: February 2012

FDA’s MedWatch Safety Alerts: February 2012
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Label Changes Approved for Statins
Recall: Oral Contraceptives
Stomach Acid Drugs Could Cause Severe Diarrhea
Recall: Infant’s Tylenol Oral Suspension
Safety Warning About Spinbrush Powered Toothbrush
Recall: Healthy People Co. Dietary Supplements
Recall: Koff & Kold and Kold Sore
Safety Labeling Changes
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.

Online4
Regular Mail: Use postage-paid, pre-addressed FDA form 35005
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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Label Changes Approved for Statins
FDA announced in two Drug Safety Communications that important changes are being made to the drug labels of a broad range of statins. The safety information for the popular cholesterol-lowering drugs is tied to their effects on liver enzymes, memory, diabetes and muscle damage. (The drug label is the package insert that comes with a prescription medication.)

Risk: The new labels include information about these potential side-effects of statins:

cognitive effects—such as memory loss or confusion—that are generally not serious and reversible
increased blood sugar
an increased risk for muscle injury under certain conditions when taking lovastatin
Removed from the labels is the recommendation that liver enzymes be routinely tested. Liver injury from statins is rare, and experts say the monitoring does not seem to be effective in predicting or preventing such damage.

Recommendations

Patients should contact their health care professional if they have any concerns about taking statins.
Health care professionals should perform liver enzyme tests before initiating statin therapy in patients and then whenever clinically indicated.
Health care professionals and patients are encouraged to report any side effects resulting from the use of these products to MedWatch.
For More Information

FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs6
Consumer Update: FDA Expands Advice on Statins7
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Recall: Oral Contraceptives
Pfizer Inc. and Glenmark Generics Inc. have each issued a nationwide recall of certain lots of oral contraceptives. Pfizer has recalled 14 lots of Lo/Ovral-28 brand and 14 lots of Norgestrel and Ethinyl Estradiol tablets because some pill packs may contain an inexact count of inert or active ingredient tablets, and the tablets may be out of sequence. These tablets are sold under the Akrimax Pharmaceuticals brand. Glenmark has recalled seven lots of Norgestimate and Ethinyl Estradiol tablets, reporting a packaging error that rotated some of the pill packs 180 degrees within their container, reversing the weekly tablet orientation.

Risk: Correct dosing is important to avoid unplanned pregnancy, and these mistakes could leave women without adequate contraception.

Recommendations

Women using pills in the affected lot numbers should begin using an alternate form of contraception immediately, notify their health care professional and return the product to the pharmacy.

Any problems should be reported to MedWatch or to the company: Akrimax Medical Information, 877-509-3935, 8 a.m.-7 p.m. CST, Monday-Friday; Glenmark Generics Inc., 888-721-7115, 8 a.m.-5 p.m EST, Monday-Friday.

For More Information

Pfizer Lot Numbers and Product Descriptions8
Glenmark Lot Numbers and Product Descriptions9
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Stomach Acid Drugs Could Cause Severe Diarrhea
FDA is warning the public that the use of certain stomach acid drugs known as Proton Pump Inhibitors (PPIs) has been linked to an increased risk of Clostridium difficile–associated diarrhea (CDAD). These drugs are used to treat conditions like gastroesophageal reflux disease (GERD). They include Nexium (esomeprazole magnesium), Prevacid (lansoprazole) and Prilosec (omeprazole).

Risk: Clostridium difficile (C. difficile) is a bacterium that can cause severe diarrhea. Patients may go on to develop more serious intestinal conditions. The disease can also be spread in hospitals.

Recommendations

Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not ease in severity. Symptoms to watch out for include watery stools, abdominal pain and fever.

For More Information

FDA Drug Safety Communication10
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Recall: Infant’s Tylenol Oral Suspension
McNeil Consumer Healthcare has recalled seven lots (about 574,000 bottles) of Infant’s Tylenol Oral Suspension, 1 oz. grape, because of complaints from consumers who had trouble extracting the liquid medication.

Risk: This over-the-counter pain reliever and fever reducer comes with a syringe that is inserted into a protective cover, called a flow restrictor, at the top of the bottle to measure the right dose. In some cases, the flow restrictor was pushed into the bottle when the syringe was inserted.

Recommendations

Do not use the product if the flow restrictor is pushed into the bottle. Contact the company for a refund at www.tylenol.com or by calling 888-222-6036, 8 a.m.-8 p.m. ET, Monday-Friday, 9 a.m-5 p.m. ET, Saturday-Sunday.

For More Information

Infants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall – Dosing System Complaints11
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Safety Warning About Spinbrush Powered Toothbrush
FDA is warning consumers and dental care professionals about reports of serious injuries and potential dangers concerning use of all models of Arm & Hammer’s Spinbrush (sold until 2009 as the Crest Spinbrush). These risks are greater for children, who may need assistance while using this device.

Risk: There have been reports that while the battery-powered Spinbrush is turned on, the brush head has either popped off or broken off in the user’s mouth or near the face. Injuries reported include chipped teeth, cuts, swallowing and choking on broken pieces and injury to the face and eyes.

Recommendations

Inspect the Spinbrush for any damage or loose brush bristles before using it. If you see either of these things, do not use the brush.
Make sure the headpiece is connected properly to the brush handle and test the brush outside of the mouth before using it. If the connection feels loose or the headpiece comes off easily, do not use it.
Supervise children or adults who need assistance when using the Spinbrush.
Do not bite down on the brush head while brushing.
Report any damage to Church & Dwight, the Spinbrush manufacturer, which can be reached toll-free at 1-800-352-3384 or 1-800-561-0752.
Report injuries or problems to MedWatch.
For More Information

FDA Drug Safety Communication12
Consumer Update13
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Recall: Healthy People Co. Dietary Supplements
Healthy People Co. is expanding its voluntary recall of dietary supplements sold under five brand names to cover products purchased on or before Oct. 25, 2011. FDA laboratory analyses have confirmed the unapproved presence of the drugs Sibutramine and Tadalafil, which could cause serious injury to people with heart-related problems or diabetes.

Risk: Sibutramine is an FDA-approved drug for appetite suppression for the treatment of obesity, but it has been withdrawn from the U.S. market. It is known to significantly increase blood pressure and/or pulse rate in some patients. This could endanger patients with a history of coronary artery disease, congestive heart failure, arrhythmias (irregular heartbeats) or stroke.

Tadalafil is an FDA-approved drug for the treatment of erectile dysfunction. It could interact with nitrates found in some prescription drugs, such as nitroglycerin, and lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease take nitrates.

The supplement brands are:

Mince Belle (30 capsules)
Everlax (30 capsules)
Ever Slim (30 capsules, strawberry shake mix and chocolate shake mix)
Acai-Man Mangosteen Herbal Drink
Perfect Men (10 capsules)
Specific lot numbers of these products (see link to numbers below) had been recalled on Feb. 2, 2011.

Recommendations

Customers who have purchased these products should return them to the company for a full refund. Call 626-939-4132, Monday through Friday, 9 a.m.-5 p.m. (PST) for instructions.

For More Information

Healthy People Co. Dietary Supplements: Recall – Undeclared Drug Ingredient14
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Recall: Koff & Kold and Kold Sore
Wholistic Herbs Inc. is recalling its Koff & Kold spray with herbal extract and Kold Sore spray with liquid sea mineral. Koff & Kold is sprayed into the nose and throat for treatment of colds, flu, cough, stuffy nose and sinus infection. Kold Sore is sprayed into the eyes for treatment of dry eye and pink eye, and into the nose for sinus allergy related to pollen, among other uses. These products have not been tested properly to ensure their safety. The recall was the result of a routine FDA inspection.

Risk: Non-sterile products used in the eye or nasal passage could lead to infections. Eye infections can damage sight.

These products were distributed from March 2009 through February 2012 to retail stores in Texas, California, Washington, Virginia, New Jersey, New York, Maryland, Illinois, Georgia, Nevada, Arizona, North Carolina, South Carolina, and Florida. They products were also distributed online and through acupuncture clinics.

Recommendations

Consumers are urged to discontinue use of these products and return them for a full refund to the place of purchase. Wholistic Herbs can be contacted directly Monday through Friday, 9 a.m. to 5 p.m. CST at 214-691-3210.

For More Information

Wholistic Herbs, Inc. “Koff and Kold” and “Kold Sore” Spray: Recall – Non-Sterile Products15
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Safety Labeling Changes
In January 2012, FDA required safety labeling changes to be made to 63 drug products, including Chantix (varenicline), Nexium (esomeprazole sodium) and Multaq (dronedarone hydrochloride).

Twenty-two of these changes were to an entire class of blood-pressure medications— including Accupril (quinapril hydrochloride) and Lotensin (benazepril)—that now carry a warning that they should not be taken by pregnant women because of the risk to injury and death to the developing fetus.

For More Information

Monthly Safety Labeling Changes16
This article appears on FDA’s Consumer Updates page17, which features the latest on all FDA-regulated products.

April 4, 2012

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