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FDA's MedWatch Safety Alerts: September 2009

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

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 a few of the most recent safety alerts prompted by reports received by FDA from health care professionals and their patients.

Recall: Children's and Infants' Tylenol Oral Suspension Products

Certain Tylenol products have been recalled as a precaution because of potential manufacturing problems. The recalled oral suspension products were distributed between March 2008 and May 2008. See McNeil Consumer Healthcare’s Web site for the full list of recalled products and their lot numbers.

The risk: The raw materials used to manufacture the products may have been contaminated by bacteria. No illnesses have been reported.


  • Check to see if you have any recalled Tylenol by looking for the lot number on the bottom of the product box and also on the sticker that surrounds the product bottle.
  • If you have given your child or infant a recalled product and you have concerns, call your health care provider.

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Choking Hazard for Lifeline Pendant Personal Help Buttons

FDA is cautioning users about personal emergency response buttons worn around the neck. These devices allow the user to push the “help” button when in distress to call for emergency assistance to their home.

The risk: FDA is aware of at least six reports between 1998 and 2009 of serious injury, including three deaths in the United States and 1 in Canada, from choking after the cord on the Philips Lifeline Personal Help Button became entangled on other objects worn around the neck.

Philips Lifeline is sending letters to its 750,000 customers and has changed the labeling of this product to include a warning against the potential choking hazard.

Recommendation: Talk to your health care provider to determine which style of emergency button, including those that are worn on the wrist, is best for you.

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Warning About Topical Ibuprofen Drugs

FDA has issued warning letters to eight companies marketing unlawful over-the-counter topical drug products containing the pain reliever ibuprofen. The warning letters advise the companies that they may not continue to market their products without FDA approval.

The risk: The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs whose safety and effectiveness are unknown. They require an approved new drug application in order to be legally marketed. Oral ibuprofen (taken by mouth) has been approved as a safe and effective treatment for pain and inflammation. FDA has not approved any applications for ibuprofen products to be applied to the skin (topically).

Do not buy these products whose manufacturers received warning letters or any products that contain ibuprofen for topical application:

  • Emuprofen (Progressive Emu Inc.)
  • BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories Inc.)
  • Ibunex Topical Ibuprofen (Core Products International Inc.)
  • LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)
  • Profen HP (Ridge Medical Products)
  • IbuPRO-10 Plus (Meditrend Inc. dba Progena Professional Formulations)
  • IBU-RELIEF 12 (Wonder Laboratories)

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Stronger Warnings for TNF Blockers

FDA is requiring stronger warnings in the prescribing information and in the patient’s Medication Guide for a class of drugs known as tumor necrosis factor (TNF) blockers.

TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab). These drugs are approved to treat several immune system diseases including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.

The risk: FDA has found an increased risk of cancer in children and adolescents who are treated with TNF blockers. An analysis revealed that about half of the cancers reported were lymphomas, a type of cancer involving cells of the immune system. Leukemia and psoriasis were also reported to be associated with using TNF blockers.


  • Read the Medication Guide that is dispensed by your pharmacy with a new prescription or refill for a TNF blocker. (See Medication Guides for Certain Prescription Products for more information on these guides.)
  • Be aware that taking TNF blockers may increase the risk of developing lymphoma, leukemia, and other cancers.
  • Be aware that taking TNF blockers may increase the risk of developing psoriasis and may worsen psoriasis if you already have it.
  • Do not stop or change your medication without first talking with your health care professional.

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Early Communication on Safety of Alli and Xenical

FDA is reviewing reports of liver injury in people taking the weight-loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli.

The risk: Between 1999 and October 2008, FDA received 32 reports of serious liver injury, including 6 cases of liver failure, in people using orlistat. The most commonly reported problems related to liver injury were yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

FDA is reviewing other data on suspected cases of liver injury. FDA has not established a definite link between liver injury and orlistat at this time.

This information is part of FDA's effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion. FDA will release its findings on orlistat as soon as it completes its review.


  • If you take Xenical, continue to take it as prescribed.
  • If you take Alli, continue to use the product as directed.
  • If you have used Xenical or Alli, talk to your health care professional if you have symptoms of possible livery injury, particularly weakness or fatigue, fever, jaundice, or brown urine. Other symptoms may include stomach pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

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Stolen Levemir Insulin May Be Dangerous

FDA continues to remind the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. may still be on the market. The stolen insulin may not have been stored and handled properly and could be dangerous for people to use. FDA has received reports of people who suffered a bad side effect due to poor control of glucose levels after using a vial from one of the stolen lots. FDA first warned the public about the stolen vials in June 2009.


  • Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038.
  • Do not use your Levemir insulin if it is from one of these lots.
  • Always look at your insulin before using it. Levemir is a clear and colorless solution.
  • Contact the Novo Nordisk Customer Care Center at 1-800-727-6500 for instructions on what to do with vials from these lots or if you have any other questions.

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Intelence and Severe Skin Reactions

FDA is requiring an update to the patient package insert and the prescribing information for Intelence (etravirine), distributed by Tibotec Therapeutics, to warn about the risk of severe, potentially life-threatening, and fatal skin reactions.

Intelence is a prescription medicine that helps to control HIV infection in adults when taken in combination with other anti-HIV medicines.

The risk: FDA has received reports of cases of severe skin reactions, some of which were accompanied by organ malfunction, including liver failure.

Recommendation: If you have signs or symptoms of severe skin or hypersensitivity reactions, stop taking Intelence immediately and contact your health care professional.

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Tysabri (Natalizumab) and Brain Infection

FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in people receiving Tysabri (natalizumab) to treat multiple sclerosis. PML is a rare brain infection that usually causes death or severe disability.

FDA approved Tysabri in November 2004 to treat relapsing forms of multiple sclerosis, and in January 2008 to treat moderately to severely active Crohn’s disease. There have been no post-market reports of PML in people treated with Tysabri for Crohn’s disease. Less than two percent of Tysabri use in the United States is by people with Crohn’s disease.

The risk: The risk for developing PML appears to increase with the number of Tysabri infusions received. Based on available worldwide data, the current rate of PML in patients who have received at least 24 infusions of Tysabri ranges from 0.4 to 1.3 per 1,000 patients.

Tysabri is available only through a restricted distribution program called the TOUCH Prescribing Program. At this time, FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri TOUCH Prescribing Program.

Recommendation: If you take Tysabri, call your doctor right away if you get any new or worsening medical problems (such as a new or sudden change in your thinking, eyesight, balance, or strength or other problems) that have lasted over several days.

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

Date Posted: September 28, 2009

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