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FDA's MedWatch Safety Alerts: May 2010

Posted Jun 02 2010 1:59pm

After the Food and Drug Administration (FDA) approves a product and it is on the market, the agency continues to monitor that product for unexpected and undesirable side effects (adverse events).

Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products 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: 1-800-FDA-0178
  • Phone: 1-800-332-1088

MedWatch reports can signal a safety problem and lead to an FDA action to protect the public from harm, serious illness, or even death.

Here are some of the most recent safety alerts prompted by reports FDA has received from health care professionals and patients.

FDA has warned consumers not to purchase or use a product called “Arrow Brand Medicated Oil & Embrocation,” also labeled as “Aceite Medicinal La Flecha” (Spanish) or “箭嘜驅風油” (Mandarin).

The product contains two substances, methyl salicylate and camphor, which are poisonous when ingested or applied to large areas of the body. 

Symptoms of poisoning from these ingredients could include

  • abdominal pain
  • nausea and vomiting
  • diarrhea
  • headache
  • visual changes
  • dizziness
  • mental confusion

The product, which is not FDA approved, claims to treat a variety of conditions. It is sold primarily in specialty stores that serve Asian and Latino communities and on the Internet.

Recommendations

  • Stop using the product and throw it away.
  • Contact a health care professional immediately if you have used the product and experienced any of the symptoms listed above.

For more information

FDA Questions and Answers for the Public in English

Questions and Answers in Spanish

Questions and Answers in Mandarin

FDA has revised the drug labels for Xenical and Alli to include new safety information about the potential rare occurrence of severe liver injury with the use of these weight-loss products. 

The active ingredient in both of these drugs is orlistat. Xenical (orlistat 120 mg) is a prescription product. Alli (orlistat 60 mg) is sold over the counter without a prescription.

Recommendations

  • Stop using Xenical and Alli and contact your health care professional immediately if you experience itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.
  • Talk to your health care professional if you have any concerns about your treatment with Xenical or Alli.

For more information

Consumer Update: Weight-Loss Drugs and Risk of Liver Failure

Questions and Answers: Orlistat and Severe Liver Injury

Drug labels for certain antacid medications will include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these products.

The drugs affected belong to a class of medications called proton pump inhibitors (PPIs), which work by reducing the amount of acid in the stomach. They are available both as prescription and as over-the-counter medications.

The prescription PPIs include

  • Nexium
  • Dexilant
  • Prilosec
  • Zegerid
  • Prevacid
  • Protonix
  • Aciphex
  • Vimovo

The over-the-counter PPIs include

  • Prilosec OTC
  • Zegerid OTC
  • Prevacid 24HR

Recommendations

  • Do not stop taking your PPI unless you are told to do so by your health care professional. PPIs are effective in treating a variety of gastrointestinal disorders.
  • Be aware that an increased risk of fractures of the hip, wrist, and spine has been reported in some studies of people who use PPIs. The greatest increased risk was seen in those who receive high doses of these medications or use them for a year or longer.
  • Read and follow the directions on the “Drug Facts” label when considering the use of an over-the-counter PPI.
  • Use over-the-counter PPIs as directed, which is only for 14 days for the treatment of frequent heartburn. If your heartburn continues, talk to your health care professional. No more than three 14-day treatment courses should be used in one year.

For a full Consumer Update, see Possible Increased Risk of Bone Fractures With Certain Antacid Drugs .

FDA has received reports of serious side effects—such as unconsciousness, hallucinations, and confusion—in people who mistakenly swallowed Benadryl Extra Strength Itch Stopping Gel instead of using it on the skin. 

The gel is safe and effective when used on the skin as directed. People who swallow it can receive dangerously large amounts of the active ingredient, diphenhydramine.

To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer has

  • changed the product label to add a new, prominent statement “For Skin Use Only”
  • attached a sticker to the cap of the product that says “For Skin Use Only”

Recommendations

  • In your home, store products for the skin separately from products that should be swallowed.
  • Read the “Drug Facts” box on the product’s label to identify active ingredients, directions for use, and warnings before using any over-the-counter drug product.
  • Check with a health care professional such as your doctor or pharmacist if you are not sure which over-the-counter product is right for you.

For a full Consumer Update, see Don't Swallow Benadryl Itch Stopping Gel—Use on Skin .

The dietary supplement Vita Breath has been recalled because the product may contain hazardous levels of lead.

People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Children are particularly vulnerable to lead poisoning, which may cause a wide range of symptoms, including

  • stomach pain
  • muscle weakness
  • nausea and vomiting
  • diarrhea
  • weight loss
  • bloody or decreased urinary output

Vita Breath is manufactured by American Herbal Lab Inc. and marketed at health fairs and on the Internet.

Recommendations

  • Do not consume Vita Breath dietary supplements.
  • Contact your health care professional if you have consumed the product and have any of the symptoms of lead poisoning listed above.

McNeil Consumer Healthcare and Blacksmith Brands Inc. have recalled certain over-the-counter children’s and infants’ liquid products because they may not meet required quality standards.

The recalled products are sold under the brand names

  • Tylenol
  • Motrin
  • Zyrtec
  • Benadryl

For a full list of McNeil's recalled products, see the company's website at www.mcneilproductrecall.com/ .

Blacksmith Brands’ recalled products, which were manufactured at a McNeil plant, include

  • PediaCare Multi-Symptom Cold, 4 oz.
  • PediaCare Long Acting Cough, 4 oz.
  • PediaCare Decongestant, 4 oz.
  • PediaCare Allergy and Cold, 4 oz.

Recommendations

  • Stop using these products. Do not give them to infants or children.
  • For more information about McNeil’s recalled products, including how to get a refund or replacement coupon, see the company’s website at www.mcneilproductrecall.com or contact McNeil at 1-888-222-6036.
  • For more information about Blacksmith Brands’ recalled products, including how to get a replacement coupon, see the company’s website at blacksmithbrands.com or contact Blacksmith Brands at 1-888-474-3099.
  • Discuss any questions you may have about these products with your pharmacist or other health care professional.

For a full Consumer Update, see Recall of Liquid Products for Children: What Consumers Need to Know .

FDA has determined it is appropriate for infants to be vaccinated with Rotarix or RotaTeq, the two licensed vaccines for rotavirus in the United States.

Rotavirus causes severe diarrhea and dehydration in infants.

FDA temporarily suspended the use of Rotarix in March 2010 when it became aware that components of a virus called PCV1 were found in the vaccine. This virus is not known to cause any disease in humans or other animals.

Lifting of the suspension is based on FDA’s careful evaluation of laboratory results from the manufacturers and its own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts.

For more information

Information for Parents and Caregivers

Update on Rotarix Vaccine

FDA is reviewing studies that suggest an increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, and stroke) in men who receive gonadotropin-releasing hormone (GnRH) agonists for the treatment of prostate cancer.

GnRH agonists are sold under the brand names Lupron, Zoladex, Trelstar, Viadur, Vantas, Eligard, and Synarel. There are also several generic products available.

FDA's review is ongoing and the agency has not made any conclusions about whether GnRH agonists increase the risk of diabetes and cardiovascular disease in people who receive these medications for prostate cancer. 

Recommendations

  • Do not stop your treatment with GnRH agonists unless you are told to do so by your health care professional.
  • Before receiving GnRH agonists, tell your health care professional if you have
  • diabetes
  • heart disease
  • had a previous heart attack or stroke
  • any cardiovascular risk factors such as high blood pressure, high cholesterol, or cigarette smoking
  • Talk to your health care professional if you have any concerns about receiving these medicines.

For more information, see FDA’s Drug Safety Communication on GnRH Agonists .

FDA now requires a medication guide to be provided to all patients when they buy Vivitrol, a drug to treat alcohol dependence.

The medication guide will warn of the risk of reactions at the site of injection and provide other important information about the drug.

Some people using Vivitrol have had severe injection site reactions, including tissue death (necrosis). Some injection site reactions have required surgery.

Recommendation: Read the medication guide before you start getting Vivitrol injections and each time you get an injection.

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

Date Posted: June 2, 2010

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