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U.S. Department of Health and Human Services

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FDA's MedWatch Safety Alerts: April 2011

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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 prompted by reports FDA has received through MedWatch.

 

Tysabri: New Safety Information

In its continued evaluation of Tysabri (natalizumab), FDA has updated the drug label regarding the risk of progressive multifocal leukoencephalopathy (PML)—a rare but serious brain infection—in those who use Tysabri to treat multiple sclerosis and Crohn's disease.

Risk: Patients who take Tysabri may be at higher risk for PML if they have taken other drugs that suppress the immune system. The revised label addresses this new risk and summarizes the rates of PML with Tysabri use per number of intravenous infusions.

In February 2010, FDA required that the drug label and the patient Medication Guide state that the risk of developing PML increases with the number of Tysabri infusions.

FDA believes that the benefits of Tysabri continue to outweigh the potential risks.

Recommendation: Before taking Tysabri, tell your health care professional if you have previously taken a medication that suppresses the immune system, such as mitoxantrone, azathioprine, methotrexate, cyclophosphamide, and mycophenolate.  

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Lansoprazole Tablets: Clogged Syringes and Feeding Tubes

Teva Pharmaceuticals has withdrawn its lansoprazole delayed-release orally disintegrating tablets from distribution. The product may also be sold under the following labels:

  • Sharp Corporation
  • Cardinal Health
  • Quality Packaging Specialist Inc.

Lansoprazole is FDA-approved to treat ulcers in the stomach and duodenum (in the small intestine), gastroesophageal reflux disease (GERD), erosive esophagitis (inflammation of the esophagus), and Zollinger-Ellison Syndrome (a condition involving overproduction of stomach acid).

Risk: The tablets have clogged and blocked oral syringes and feeding tubes when the drug is given as a suspension through these devices. The tablets may not fully disintegrate when water is added to them or they may form clumps. These clumps can stick to the inside walls of syringes and feeding tubes. In some cases, patients have had to seek emergency medical help and their feeding tubes have had to be unclogged or replaced.

Recommendation: Do not give this product through oral syringes or feeding tubes. 

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Topamax Recall: Musty Smell

Two lots of Topamax (topiramate) 100mg tablets in bottles of 60 have been recalled:

  • Lot number 0KG110, expiration date of 06-2012
  • Lot number 0LG222, expiration date of 09-2012

Topamax, a product of the Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals Inc., is FDA-approved to treat some types of seizures in adults and children, and to prevent migraine headaches in adults.

Risk: Several consumers have reported an unusual odor, which is thought to be caused by trace amounts of a chemical compound called TBA (2,4,6 tribromoanisole). While not considered to be toxic, TBA can give off an offensive odor. A small number of patients have reported temporary problems of the stomach or intestines.

Recommendations

  • If you notice an unusual odor from Topamax 100mg tablets, return them to your pharmacist.
  • Contact your health care professional if you have questions.

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TNF Blockers, Imuran, and Purinethol: Reports of Rare Cancer

FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma, or HSTCL), occurring mainly in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with the following medicines:

  • tumor necrosis factor (TNF) blockers, including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab)
  • Imuran (azathioprine)
  • Purinethol (mercaptopurine)

Crohn's disease and ulcerative colitis cause inflammation of the digestive system.

Risk: HSTCL is a fast-growing cancer that is usually fatal. Most of the cases reported were in people being treated for Crohn’s disease or ulcerative colitis, but also included a person being treated for psoriasis and two people being treated for rheumatoid arthritis.

Although most reported cases of HSTCL occurred in people treated with a combination of medicines known to suppress the immune system—including TNF blockers, azathioprine, and mercaptopurine—there have been cases reported in people receiving azathioprine or mercaptopurine alone.

Recommendations

  • Be aware that taking TNF blockers, azathioprine, or mercaptopurine may increase the risk of HSTCL.
  • Read the Medication Guide that comes with a prescription for TNF blockers.
  • Do not stop taking TNF blockers, azathioprine, or mercaptopurine without talking to your health care professional.
  • Discuss any questions or concerns about these medications with your health care professional.

For More Information

FDA Drug Safety Communication

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Benzocaine Products: Reports of Potentially Fatal Condition

FDA continues to receive reports of methemoglobinemia—a rare but serious condition—associated with benzocaine products. These products may be used either as

  • a spray during medical procedures to numb the mucous membranes of the mouth and throat
  • a gel or liquid sold over-the-counter to relieve pain from teething, canker sores, irritation of the mouth and gums, and other conditions. Brand names include Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands.

Risk: Methemoglobinemia is a condition in which the amount of oxygen carried through the bloodstream greatly decreases. In the most severe cases, methemoglobinemia can result in death.

Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids. The condition occurred mainly in children age two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear from within minutes to hours of applying benzocaine and may occur after just one use or after additional uses.

Signs and symptoms of methemoglobinemia include

  • pale, gray, or blue colored skin, lips, and nail beds
  • headache
  • lightheadedness
  • shortness of breath
  • tiredness
  • rapid heart rate

Recommendations

  • Call 911 immediately if you or someone you are caring for has any of the symptoms listed above after receiving benzocaine.
  • Do not use benzocaine products on children under two years of age, except under the advice and supervision of a health care professional.
  • Adults who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations on the product label.
  • Store benzocaine products out of reach of children.
  • Talk to your health care professional about using benzocaine.

For More Information

Questions and Answers on Benzocaine

Drug Safety Communication: Benzocaine Gels, Liquids

Drug Safety Communication: Benzocaine Sprays

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Best Enhancer: Recall

FDA laboratory analyses found that the Best Enhancer product, marketed as a dietary supplement, contains an active ingredient that is similar to an FDA-approved product used to treat erectile dysfunction. The active drug ingredient is not listed on the label of Best Enhancer.

Risk: The active ingredient may interact with prescription drugs containing nitrates (such as nitroglycerin) and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease are often prescribed drugs containing nitrates.

Recommendations

  • If you have bought this product, stop using it and return it to the place of purchase.
  • If you have questions, contact the product’s distributor, AVNS Inc., at 562-602-6515 or avnsinc@aol.com Monday through Friday from 9:00 a.m. to 4:00 p.m. Pacific Standard Time.

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

May 13, 2011

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