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MedWatch Safety Alerts: March 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
  • 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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Celexa: Dose Level Boosts Risk of Abnormal Heart Rhythms

FDA is clarifying dosing recommendations and warnings for the antidepressant Celexa (citalopram hydrobromide). In August 2011, the agency issued a Drug Safety Communication stating that citalopram should no longer be used at doses greater than 40 milligrams (mg) per day because it could cause potentially dangerous abnormalities in the heart’s electrical activity. Use of citalopram is discouraged at any dose for people with certain medical conditions. However, because some patients may lack viable alternatives, the citalopram label (the package insert that comes with a prescription medicine) has been changed to describe precautions they should take when using it. The revised label also describes lower doses that should be taken by people over 60 years old.

Risk: Changes in the electrical activity of the heart—specifically, prolongation of the QT interval, a measure of the heart’s electrical activity— can lead to a risk of a potentially fatal abnormal heart rhythm called Torsades de Pointes. People at risk for developing QT prolongation include those with underlying heart conditions and those who tend to have low levels of potassium and magnesium in their blood.

Recommendations

  • Do not stop taking citalopram or change your dose without talking to your health care professional. Stopping citalopram suddenly can cause withdrawal effects.
  • If you are currently taking a citalopram dose greater than 40 mg per day, talk to your healthcare professional.
  • Seek immediate care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking citalopram.
  • If you are taking citalopram, your health care professional may occasionally order an electrocardiogram (ECG, EKG) to monitor your heart rate and rhythm.
  • Your health care professional may also order tests to check levels of potassium and magnesium in your blood.
  • Read the Medication Guide for citalopram carefully and discuss any questions you have with your health care professional.
  • Health care professionals and patients are encouraged to report any side effects related to the use of these products to MedWatch.

For More Information

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Taking Statins With HIV or Hepatitis C Drugs Raises Muscle Injury Risk

FDA has notified health care professionals of updates to prescribing information for protease inhibitors and certain statin drugs. Protease inhibitors are antiviral drugs used to treat HIV—the virus that causes AIDS—and the Hepatitis C virus (HCV). Statins are used with diet and exercise to reduce low-density lipoprotein (LDL, or “bad”) cholesterol. Taking protease inhibitors and statins together raises levels of statins in the blood and increases the risk of muscle injury.

Risk: The most serious form of this muscle injury, called rhabdomyolysis, can damage the kidneys and cause kidney failure, which can lead to death.

HIV and HCV protease inhibitors should never be taken with lovastatin (Mevacor) and simvastatin (Zocor). Health care providers are advised to use caution when prescribing atorvastatin (Lipitor).

Recommendations

  • Health care professionals and patients are encouraged to report any side effects related to the use of these products to MedWatch.
  • Patients are asked to contact their health care professionals if they have questions about either protease inhibitor or statins.

For more information

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Some Skin Care Products May Contain Mercury

FDA has notified health care professionals and warned consumers not to use skin creams, beauty and antiseptic soaps or lotions that might contain the toxic metal mercury. These products, found in at least seven states, claim to be skin lighteners and anti-aging treatments that remove age spots, freckles, blemishes and wrinkles. Adolescents may use them to treat acne. They are manufactured abroad and sold illegally in the United States—often in shops in Latino, Asian, African or Middle Eastern neighborhoods, and online—or brought to the U.S. from other countries. FDA and state health officials have found more than 35 products containing unacceptable levels of mercury.

Risk: Mercury poisoning can cause damage to the kidneys and the nervous system, and interfere with brain development in unborn children and very young children.

Recommendations

  • Check the label of any skin lightening, anti-aging, or other skin product. If there is no label or no ingredients listed, do not use the product.
  • Do not use—or immediately stop using—products that list these ingredients: mercurous chloride, calomel, mercuric, mercurio or mercury.
  • Thoroughly wash hands and any other body parts that have come in contact with the product.
  • Contact a health care professional or medical clinic for advice.

For more information

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Recall: Gerber Good Start Gentle Powdered Infant Formula

Gerber Products Company has recalled one lot of Gerber Good Start Gentle Powdered Infant Formula, 23.2 ounce plastic package, because the product might have a noticeable off-odor. The recall applies to batch GXP1684, expiration date of March 5, 2013. Gerber is working with retailers to retrieve any remaining product from this batch.

Risk: In some cases, spit-up and other gastrointestinal complaints have been reported.

Recommendations

  • If you have the product with the batch code and expiration date mentioned above, contact the Gerber Parents Resource Center at 1-800-487-7763.
  • Report problems or side effects related to the use of this product to MedWatch.

For More Information

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Recall: Brilliant Blue G Compounded by Franck’s Lab

FDA has received reports from several states of eye infections (fungal endophthalmitis) in patients who were given an ophthalmic solution called Brilliant Blue G (BBG) during eye surgeries. FDA, the Centers for Disease Control and Prevention, and local and state public health agencies are actively investigating these cases.

The BBG was supplied by Franck’s Compounding Lab, Ocala, FL., which issued a recall on March 9, 2012, of all lots of Brilliant Blue G. Brilliant Blue G is not an approved drug in the U.S.

Risk: Endophthalmitis is a serious condition involving swelling (inflammation) within the eyeball.

Recommendations

  • Report problems or side effects related to the use of Brilliant Blue G to MedWatch.

For More Information

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Safety Labeling Changes

In February 2012, FDA required safety labeling changes to be made to 65 drug products, including eight different drugs that now carry a warning that they should not be taken by pregnant women because of the risk of injury and death to the developing fetus.

The list also included warnings for conjugated estrogen products Premarin Vaginal Cream and Prempro and Premphase Tablets, as the cause for anaphylaxis, a reaction that may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat.

For More Information

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

April 19, 2012

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