All prescription drugs that desire to be marketed in the U.S. must gain the approval of the Food and Drug Administration (FDA). Through the Center for Drug Evaluation and Research (CDER), which assures that safe and effective drugs are available to the American people, a prescription drug must pass a series of trials. Please understand that the FDA does not develop, manufacture or test drugs. Drug manufacturers submit full reports of a drug’s studies to the CDER so that the Center can evaluate its data. The studies answer the question, “Does this drug work for the proposed use?” By analyzing the data, CDER reviewers assess the benefit-to-risk relationship and determine if the drug will be approved. Once the drug has been placed on the market, the FDA continues to monitor it through post-marketing reports sent in by the manufacturer and through the MedWatch program – an FDA program that allows consumers and health care professionals to report serious side effects, quality control issues, and medical errors associated with drugs and products regulated by the FDA.

Sometimes, an unanticipated side effect manifests itself once the drug has been made available to the U.S. market. If the side effect is serious enough, the FDA may issue a warning to the public and request that changes be made to the drug’s label. If the side effect is extremely serious and the FDA decides that the risks of the drug outweigh its benefits, then the FDA may recall the drug.

Speak to a Lawyer

Each year, thousands of people die from or are seriously injured by prescription drugs, over-the-counter drugs and medical devices they believe to be safe. If you or a loved one have taken a defective drug, experienced problems with a defective medical device or used a defective product, then contact our law firm immediately. Consult an attorney privately to learn your legal rights. All information is held in the strictest of confidence.

Contact a Drug and Pharmaceutical Liability Attorney

For a free and confidential consultation, fill out our online case evaluation form or call us toll free at: 1-800-883-9858.

Legal help: Contact an Attorney

Inspections, Compliance, Enforcement, and Criminal Investigations

Depuy Orthopaedics, Inc. 8/19/10

Department of Health and Human Services
Public Health ServiceFood and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

WARNING LETTER

August 19, 2010

David Floyd
President
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582

RE: TruMatch™ Personalized Solutions System
Corail® Hip System
Refer to GEN0901195 when replying to this letter.

Dear Mr. Floyd:

The Food and Drug Administration (FDA) has learned that your firm is marketing the TruMatch™ Personalized Solutions System and the Corail® Hip System in the United States (U.S.) without the required marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website, www.depuyorthopaedics.com for the TruMatch™ Personalized Solutions System and the Corail® Hip System. The products are devices within the meaning of section 201(h) of the Act 21 U.S.C. § 321(h), because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.

TruMatch™

A review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch™ Personalized Solutions System for sale, which is a violation of the law. Specifically, the TruMatch™ Personalized Solutions System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for investigational device exemptions (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution. as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Corail® Hip System

A review of our records indicates that we cleared a premarket notification (510(k)) for the Corail® Hip System, K042992, with an intended use for total hip arthroplasty “to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.” In addition, total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

The non·porous Corail AMT Hip Stem is indicated for cementless use only.

However, a brochure on your website,

http://www.depuyorthopaedics.com/HealthCare/Related%20Documents/HIPS/CEMETL

ESS%20STEMS/CORAIL%20AMT/DO Corail_AMT_ Design Rationale_ 0612-70-501r2.pdf, states the following claims about the Corail® Hip System:

• “Proprietary HA coating for initial osteointegration and fixation” (page 3);
• “Proprietary HA coating … clinically demonstrated rapid trabeculae formation leading to rapid fixation,” and “promotes osteointegration for excellent fixation” (page 4);

Promotion of this device for osseointegration (a.k.a. osteointegration), whether explicitly or implicitly (for example, through fixation claims that imply osseointegration). represent a major change or modification in the intended use of your device that require a new premarket notification. 21 CFR 807.81(a)(3)(ii). Because of these claims, the Corail® Hip System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section, 502(o) of the Act, 21.U.S.C. 352(o), because you did not submit to FDA a notification respecting the changes to the intended use of the device, as required by section 510(k) of the Act, 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(ii).

FDA requests that DePuy Orthopaedics, Inc. immediately cease marketing the Corail® Hip System for unapproved uses such as those described above. You should take prompt action to correct the violations listed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and lor civil money penalties.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations for the TruMatch™ Personalized Solutions System and the Corail® Hip System, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please include in your response a list all promotional materials for the Corail® Hip System containing claims for unapproved uses such as those described above, and explain your plan for discontinuing such claims.

Your response should be sent to:

Matthew Krueger
Chief
Orthopedic and Physical Medicine Devices Branch
Office of Compliance
Center for Devices and
Radiological Health
WO 66, Room 3676
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

If you have any questions about the content of this letter please contact: Amy Skrzypchak at phone number (301) 796-5613 or amy.skrzypchak@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations by your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations, and to bring your products into compliance.

Sincerely,

/s/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

******************************************

DePuy Hip Implant Attorney

If you or a loved one have been injured as the result of a DePuy Orthopaedics – Johnson & Johnson  hip replacement implant product, talk to a DePuy Hip Implant Attorney at the Willis Law Firm for legal advice about a potential DePuy hip replacement lawsuit.  Please fill out the Free Case Evaluation at the right or call us toll-free at 1-800-883-9858.

IMPORTANT NOTE: If you are required to have a revision replacement surgery to remove and replace a faulty DePuy Hip Implant, notify your doctors that you want the hip implant to be preserved as evidence and NOT shipped or returned to the manufacturer, as it is critical evidence in a potential product liability lawsuit against DePuy and Johnson & Johnson.

FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between March 26, 2009 and December 15, 2009. There is a potential for the device to unexpectedly:

• Power Off then On by itself.
• Power Off then NOT turn On.
• Power Off by itself requiring the operator to turn it back On.
• Stay powered On and not allow itself to be turned Off.

Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

The U.S. Consumer Product Safety Commission (CPSC) is advising parents and caregivers to be cautious when using infant slings for babies younger than four months of age. In researching incident reports from the past 20 years, CPSC identified and is investigating at least 14 deaths associated with sling-style infant carriers, including three in 2009. Twelve of the deaths involved babies younger than four months of age.

Slings can pose two different types of suffocation hazards to babies. In the first few months of life, babies cannot control their heads because of weak neck muscles. The sling’s fabric can press against an infant’s nose and mouth, blocking the baby’s breathing and rapidly suffocating a baby within a minute or two. Additionally, where a sling keeps the infant in a curled position bending the chin toward the chest, the airways can be restricted, limiting the oxygen supply. The baby will not be able to cry for help and can slowly suffocate.

Many of the babies who died in slings were either a low birth weight twin, were born prematurely, or had breathing issues such as a cold. Therefore, CPSC urges parents of preemies, twins, babies in fragile health and those with low weight to use extra care and consult their pediatricians about using slings.

Two months ago, the Commission added slings to the list of durable infant products that require a mandatory standard. Additionally, CPSC staff is actively investigating these products to determine what additional action may be appropriate. Until a mandatory standard is developed, CPSC is working with ASTM International to quickly complete an effective voluntary standard for infant sling carriers.

CPSC recommends that parents and caregivers make sure the infant’s face is not covered and is visible at all times to the sling’s wearer. If nursing the baby in a sling, change the baby’s position after feeding so the baby’s head is facing up and is clear of the sling and the mother’s body. Parents and caregivers should be vigilant about frequently checking their baby in a sling.

American Regent Voluntarily Recalls All Lots of Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials

American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 30 mg/mL:

• NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial
• NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)

This voluntary recall is due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of AMERICAN REGENT Ketorolac Tromethamine Injection, USP. American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.

The product was distributed to wholesalers and distributors nationwide and to one account in Abu Dhabi.

Hospitals, surgi-centers, clinics and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return.

“Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks,” said Mary Jane Helenek, President and CEO of American Regent.

On Friday, October 16, 2009, American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. This recall does not affect the other strength of Ketorolac Tromethamine Injection, USP, 15mg/mL, 1 mL Single Dose Vial, NDC # 0517-0601-25.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the Agency.

As is standard practice, and as stated in the Ketorolac Tromethamine Injection Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.”

American Regent will credit accounts for all returned Ketorolac Tromethamine Injection, USP product. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, surgi-centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-9236. Adverse reactions may also be reported to FDA’s MedWatch Adverse Event Reporting program online, by phone [1-800-FDA-1088], or by returning the postage paid FDA form 3500, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178].

Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: Unomedical MPR Recall. This recall is being conducted because of a potential malfunction of certain units of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death. This recall does not impact any MPRs manufactured after March 2008.

Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers. In addition, the company has set up a web page with a list of affected lot numbers, guidance (diagram and photos) to allow customers to identify products subject to the recall in the event that the customer has already removed the primary product packaging, and instructions on what actions to take.

In order to distinguish between the recalled product and unaffected product, customers may examine the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned to Unomedical as instructed. MPR units with a clearly visible blue retention ring are not affected and do not need to be returned.

The MPR is a single-patient use device used by healthcare professionals. It is intended for patients requiring total or intermittent ventilatory support.

Unomedical notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the product on October 1, 2009.

Customers with questions are urged to contact Unomedical at 1-800-634-6003. Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF- 2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at: www.fda.gov/medwatch.

New USP Standards for Heparin Products Will Result in Decreased Potency
Adjustments may be Needed to Achieve Desired Anticoagulant Effect in Some Patients
New Heparin to Ship Starting October 8

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.

Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.

Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.

Prescription and over–the–counter medicines available in the United States must generally meet USP’s public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.

The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.

Philips announced today that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May, 2007 and January, 2008 are included in the voluntary recall.

The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy.

Philips has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during routine self tests, not during emergency use of the AED. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated, although Philips has received no reports of injury associated with this chip failure.

The AEDs affected by this recall have been distributed globally to fire departments, emergency medical services, hospitals, and other organizations. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs by sending notification letters to distributors and users. In addition, the company has set up a page on the Philips Web site with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is. The webpage is: www.philips.com/FR2PlusAction.

Philips has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Customers who have questions about the recall or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.

Any adverse events experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at: www.fda.gov/medwatch.

FDA Warns Consumers Not to Use Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution

The U.S. Food and Drug Administration today advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.

The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.

Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although the FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:

Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)

• Lot number 9G04, NDC # 49502-697-29
• Lot number 9FD8, NDC # 49502-697-61
• Lot number 9FD9, NDC # 49502-697-61
• Lot number 9FE1, NDC # 49502-697-61

Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)

• Lot number F09089, NDC # 49502-685-31
• Lot number C09119, NDC # 49502-685-62
• Lot number C09120, NDC # 49502-685-62

Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.

Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.

Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278. Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.

FDA Issues Early Communication about Ongoing Safety Review of Orlistat.
Weight loss drug review includes both prescription drug Xenical and OTC drug Alli.

The U.S. Food and Drug Administration announced today that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli.

Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board.

“The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,” said Steven Osborne, M.D., executive director of the Board.

The FDA’s analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time. Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.

For more information on the Early Communication about the ongoing safety review please read: Orlistat (Marketed as Alli and Xenical) Safety Review. The Early Communication is a risk communication tool used by the FDA to inform the public about its ongoing safety reviews of drugs. The FDA will release its findings on orlistat as soon as the review is completed.

Consumers who have used orlistat should consult a health care professional if they experience symptoms possibly associated with development of liver injury, particularly weakness or fatigue, fever, jaundice, or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

The FDA urges both health care professionals and consumers to report suspected side effects from the use of orlistat to FDA’s MedWatch Adverse Event Reporting program.

FDA’s Early Communication about the Ongoing Safety Review of Orlistat.

FDA is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli.

Xenical (orlistat 120mg) was approved as a prescription product by FDA in 1999 for obesity management in conjunction with a reduced caloric diet, and to reduce the risk of regaining weight after prior weight loss. In 2007, Alli (orlistat 60mg) was approved for OTC use for weight loss in overweight adults, 18 years and older, in conjunction with a reduced-calorie and low-fat diet. Currently, orlistat is approved for marketing in approximately 100 countries. In January 2009, a nonprescription version of orlistat was approved for sale in the European Union.

Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases.

In addition to the 32 reported cases, this issue was discussed at the CDER Drug Safety Oversight Board in April 2009, and FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA’s analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time.

FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.

Consumers should consult their health care professional if they are experiencing symptoms possibly associated with the use of orlistat and development of liver injury, particularly weakness or fatigue, fever, jaundice or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA’s MedWatch Adverse Event Reporting program.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will communicate its findings to the public as soon as its review of orlistat is complete.

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. The FDA will release an update when additional information or analyses become available.