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U.S. Department of Health and Human Services

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FDA's MedWatch Safety Alerts: July 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.

Use of Surgical Mesh Is Risky

Surgery to repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI) that involves the placement of a mesh material through the vagina may expose women to a greater risk of complications than would other forms of the surgery.

The number of problems reported to FDA has continued to climb since the agency first issued a safety communication about surgical mesh in 2008. It is not clear that POP repair through the vagina with mesh is more effective than traditional non-mesh repair in which surgeons repair the damage with stitches alone. FDA continues to evaluate the effects of using surgical mesh to repair SUI.

POP occurs when the tissues that hold a woman’s pelvic organs in place become weak or stretched, causing the organs to bulge (prolapse) into the vagina or past the vaginal opening. SUI is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.

Surgical mesh—a porous material—may be permanently implanted to reinforce the weakened vaginal wall to repair POP or to support the urethra to treat incontinence.

Risk: Reported problems include mesh becoming exposed or protruding out of the vaginal tissue, pain, infection, bleeding, pain during sexual intercourse, urinary problems, and organ perforation from surgical tools. Women may need more surgery because of mesh-related complications. In a small number of women, repeat surgery may not fix the problem.

Recommendations

  • Ask the surgeon before surgery about all treatment options, including those that do not involve mesh, and make sure you understand why the surgeon may be recommending treatment with mesh.
  • See a list of questions (under “Recommendations for Patients”) to ask your surgeon before surgery.
  • Continue with routine checkups and follow-up care after surgery. Notify the surgeon if you have complications, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain during sex.
  • If you’ve had POP or SUI surgery but don’t know if the surgeon used mesh, find out during your next scheduled visit with your health care professional.

For More Information

Urogynecologic Surgical Mesh Implants

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Dietary Supplements’ That Contain a Risky Drug

The following products by Intercharm Inc. are recalled

  • Slimforte Slimming Capsules (box of 30), Batch No. 20100928, Best By 09.27.2012 and Batch No. 20100604, Best By 06.03.2012
  • Slimforte Slimming Coffee (box of 10 packets), Batch No. 20100903, Best By 09.02.2012
  • Meizitang Botanical Slimming Soft Gel (pouch of 3 blister packs of 12 each 650 mg softgel capsules), Lot Code 12.24.2009, Best By 12.23.2011

These products—sold as dietary supplements and marketed for weight loss—contain sibutramine, a controlled substance that was removed from the U.S. market in October 2010 for safety reasons. They were distributed through the Internet nationwide and internationally to Ireland.

See photos of the recalled products.

Risk: Sibutramine is known to substantially increase blood pressure or pulse rate in some people—especially those with a history of heart disease or stroke. These products may also interact in life-threatening ways with other medications a person may be taking.

Recommendations

  • Stop using these products immediately and throw them away.
  • If you’ve experienced any negative side effects from these products, contact a health care professional as soon as possible.
  • If you have questions related to the recall, call the distributor, Intercharm, at 323-876-7441 Monday–Friday 8:00 a.m. to 4:30 p.m. Eastern Standard Time.

For More Information

Tainted Weight Loss Products

Beware of Fraudulent ‘Dietary Supplements’

Beware of Fraudulent Weight-Loss ‘Dietary Supplements’

How to Dispose of Unused Medicines

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Tamiflu: Concentration Lowered

The oral suspension form of Tamiflu will be made in a new, lower concentration of 6 mg/mL to replace the 12 mg/mL concentration and reduce the possibility of medication errors. The lower concentration is less likely to become frothy when shaken, which helps to ensure an accurate measurement. The 12 mg/mL product will continue to be sold until current supplies expire.

Oral suspension is a powder form of the prescription medication that a pharmacist mixes with water to make a liquid treatment easier to take by children or adults who are unable to swallow a Tamiflu capsule.

Tamiflu is FDA-approved to treat adults and children older than 1 year who have had flu symptoms for two days or less.

Recommendations

Be aware that

  • You may be given either concentration of Tamiflu oral suspension at your pharmacy during the upcoming flu season.
  • The new Tamiflu for oral suspension container label and carton packaging look different from what you may have taken in the past.
  • The new oral dosing device (syringe) is different and the volume (mL) of your dose may differ from past prescriptions.

For More Information

FDA Consumer Update on Tamiflu

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Chantix: New Effectiveness Information, Risk of Certain Heart Problems

Chantix (varenicline)—a drug to help people quit smoking—will have an updated label to include information about the drug’s effectiveness and the slightly increased risk of heart problems in people who have

  • cardiovascular disease (heart and blood vessel problems)
  • chronic obstructive pulmonary disease, or COPD (narrowing of small airways connected to the lungs, leading to difficulty breathing)

People with either of these diseases may greatly benefit from giving up smoking.

FDA’s review of clinical trials showed that Chantix was more effective than an inactive pill (placebo) in helping people with cardiovascular disease or COPD quit smoking and not go back to smoking for as long as one year.

Risk: Chantix (varenicline) may be associated with a small, increased risk of certain heart problems—including heart attack—in people who have cardiovascular disease. This safety information will be added to the drug label and the patient Medication Guide—printed material given to consumers at the pharmacy along with their prescription medication.

Recommendations

  • Contact your health care professional if you have new or worsening symptoms of cardiovascular disease while taking Chantix, such as
    • shortness of breath or trouble breathing
    • new or worsening chest pain
    • new or worse pain in legs when walking
  • Read the Medication Guide you get along with your Chantix prescription

For More Information

Varenicline (marketed as Chantix) Information

FDA 101: Smoking Cessation Products

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Drug Interactions: Zyvox, Methylene Blue, and Psychiatric Medications

Serious central nervous system reactions have been reported when the antibacterial drug Zyvox (linezolid) or the drug methylene blue is taken by people who are also taking certain psychiatric medications that work through the serotonin system of the brain. Serotonin is a neurotransmitter that helps relay signals from one area of the brain to another.

Safety information about these potential drug interactions and recommendations for use are being added to the labels of serotonergic psychiatric medications.

Linezolid is used to treat infections, including pneumonia, skin infections, and infections caused by the resistant bacterium Enterococcus faecium. Methylene blue is used as a dye in diagnostic procedures and also to treat a number of medical conditions.

Recommendations

  • You may need to temporarily stop taking your serotonergic psychiatric medication if it becomes necessary for you to take linezolid or methylene blue.
  • Do not stop taking your serotonergic psychiatric medicine without first talking to a health care professional.
  • Make sure your health care professional knows about all the medications you are taking.
  • Contact your health care professional immediately if you are taking a serotonergic psychiatric medication and develop any of the following symptoms:
    • mental changes (confusion, hyperactivity, memory problems)
    • muscle twitching
    • excessive sweating
    • shivering or shaking
    • diarrhea
    • trouble with coordination
    • fever

For More Information

Drug Safety Communication on Zyvox (Linezolid)

Drug Safety Communication on Methylene Blue

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Fosamax, Boniva, and other Bisphosphonates: Potential Risk of Cancer of Esophagus

FDA continues to evaluate whether the use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus. There have been conflicting findings from studies that evaluate that risk. Oral bisphosphonate drugs include

  • Fosamax (alendronate)
  • Actonel (risedronate)
  • Boniva (ibandronate)
  • Atelvia (risedronate delayed release)
  • Didronel (etidronate)
  • Skelid (tiludronate)

Oral bisphosphonates are commonly used to prevent and treat osteoporosis and other bone diseases.

FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer. FDA will continue to evaluate all available data about the safety and effectiveness of these drugs and will update the public when more information becomes available.

At this time, FDA believes that the benefits of oral bisphosphonate drugs in reducing the risk of serious fractures in people with osteoporosis continue to outweigh their potential risks. Esophageal cancer is rare, especially in women.

Recommendations

  • Talk to your health care professional about the benefits and risks of taking oral bisphosphonates and how long you should expect to take them.
  • Follow directions carefully for using oral bisphosphonate drugs.
  • Talk to your health care professional if you develop swallowing difficulties, chest pain, new or worsening heartburn, or have trouble or pain when you swallow.
  • Don’t take oral bisphosphonates if you have esophageal conditions that delay emptying of the esophagus, cannot stand or sit upright for at least 30 to 60 minutes, or have low calcium levels in your blood.

For More Information

Drug Safety Communication: Ongoing Safety Review of Oral Osteoporosis Drugs

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Drug Safety Labeling Changes

In June, FDA required labeling changes to be made to 50 drug products, including Zocor, Prilosec, Pepcid, and Lyrica. Changes were made to the prescribing information and, in some cases, to the patient package inserts and medication guides to warn about potential bad reactions, tell who shouldn’t take the drug, or give other safety information.

For More Information

Monthly Safety Labeling Changes

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

Aug. 22, 2011

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