U.S. FDA Recalls

March 10 2010 - Cangene, Baxter and FDA notified healthcare professionals that cases of intravascular hemolysis (IVH) and its complications, including fatalities, have been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho SDF. IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome. Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation have also been reported. Fatal outcomes associated with IVH and its complications have occurred most frequently in patients of advanced age (age over 65) with co-morbid conditions.

The Boxed Warning informs healthcare professionals that:

• Patients should be closely monitored in a health care setting for at least eight hours after administration
• A dipstick urinalysis should be performed at baseline, 2 hours, 4 hours after administration and prior to the end of the monitoring period
• Patients should be alerted to and monitor for signs and symptoms of IVH, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently.
• If signs and/or symptoms of IVH are present or if IVH is suspected after WinRho administration, post-treatment laboratory tests should be performed including plasma hemoglobin, urinalysis, haptoglobin, LDH and plasma bilirubin (direct and indirect).

Read the complete MedWatch 2010 Safety summary, including a link to the Dear Healthcare Professional letter, revised Prescribing Information and Information for Patients document, at:  MedWatch Information

March 8 2010 - Velaglucerase alfa (VPRIV By Shire) has been approved by the FDA for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients. Prescribing Information

March 1 2010 - Pneumococcal 13-valent vaccine ( Prevnar 13 by Pfizer) has been approved by the FDA for infants and young children ages 6 weeks through 5 years.  Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease-causing bacteria. Prescribing Information

February 23 2010 - Rituximab (Rituxan by Genentech) has been approved by the FDA to treat certain patients with chronic lymphocytic leukemia. Prescribing Information

February 23 2010 - Meningococcal conjugate vaccine (Menveo by Novartis) has been approved by the FDA for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11 to 55 years of age.  Prescribing Information

February 22 2010 - FDA notified healthcare professional and patients that it is reviewing the primary data from a large, long-term clinical study, RECORD, on possible cardiovascular risks with the diabetes drug, Avandia (rosiglitazone). In addition to the clinical trial, a number of observational studies of the cardiovascular safety of rosiglitazone have been published and FDA has been reviewing these on an ongoing basis. 

These reviews are ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time. Once FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a public meeting in July 2010. The Agency will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.

FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing rosiglitazone. This includes a Boxed Warning. Patients should continue taking rosiglitazone unless told by their healthcare professional to stop. Patients who are concerned about the possible risks associated with using rosiglitazone should talk to their healthcare professional.  Medwatch Information

February 19 2010 - FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all LABAs. The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma. 

Healthcare professionals are reminded that to ensure the safe use of these products:

• Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
• LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
• LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
• Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.

FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs. Medwatch Information

February 18 2010 - FDA notified consumers and healthcare professionals about reports of serious medication errors involving consumers who used Maalox Total Relief when they had intended to use a Maalox liquid antacid product. Maalox Total Relief and the traditional Maalox products are both liquid medications available without a prescription, but are not interchangeable and are intended to treat different medical conditions. Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids.

Maalox Total Relief is not appropriate for individuals who want to use an antacid, since it contains the active ingredient bismuth subsalicylate which is chemically related to aspirin and may cause serious adverse effects such as bleeding. Maalox Total Relief should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding disorder. It also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs. 

The Drug Safety Communication contains additional information for consumers and healthcare professionals, as well as product label photos. Medwatch Information

February 16 2010 - FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving an ESA. Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program. FDA is requiring a REMS because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions. MedWatch Information

February 12 2010 - Olmesartan (Benicar by Daiichi Sankyo) has been approved by the FDA for hypertension treatment in children and adolescents 6 to 16 years of age. Prescribing Information

February 9 2010 - Rosuvastatin (Crestor by AstraZeneca) has been approved by the FDA for use as a preventive measure against heart attack and stroke in patients with healthy cholesterol levels. Prescribing Information

February 8 2010 - Lamotrigine (Lamictal XR by GlaxoSmithKline), has been approved by the FDA as add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures. This is an expanded label, as Lamictal XR is approved for partial onset seizures (with or without secondary generalization) for patients in this age group.  Prescribing Information

February 8 2010 - Collagenase clostridium histolyticum (Xiaflex by Auxilium Pharmaceuticals), has been approved by the FDA to treat Dupuytren's disease, a hand disease that causes "bent" fingers. Prescribing Information

February 5 2010 - FDA notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide. Information about the occurrence of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients who have developed PML and subsequently discontinued Tysabri has also been added to the drug label. IRIS is a rare condition characterized by a severe inflammatory response that can occur during or following immune system recovery, causing an unexpected decline in a patient’s condition after return of immune function.

Based on the available information, FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases. Medwatch Information

February 2 2010 - Lapatinib (Tykerb by GlaxoSmithKline),has been approved by the FDA for use in combination with the  cancer drug letrozole (Femara by Novartis) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women. Prescribing Information

January 28 2010 - FDA notified healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine), a medication used to treat human immunodeficiency virus (HIV) infection. FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA's Adverse Event Reporting System. Based on the number of well-documented cases and exclusion of other causes of portal hypertension such as alcohol-related cirrhosis or hepatitis C, FDA concludes there is an association between use of didanosine and development of non-cirrhotic portal hypertension. Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, FDA has revised the Warning and Precautions section of the didanosine drug label to assure safe use of the medication. FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient. Medwatch Information

January 28 2010 - Dalfampridine (AMPYRA by Elan Drug Technologies) has been approved by the FDA as a treatment to improve walking in patients with multiple sclerosis (MS).  Prescribing Information

January 28 2010 - Liraglutide (Victoza by Novo Nordisk), has been approved by the FDA for treating type 2 diabetes.   Prescribing Information

January 27 2010 - Takeda Oncology and FDA notified healthcare professionals about revisions to the Prescribing Information for Velcade, section 2.5, pertaining to patients with hepatic impairment at the start of Velcade therapy. The changes also include new safety information on dose adjustment for patients with moderate to severe hepatic impairment in label Section 5.11, stating: "Bortezomib is metabolized by liver enzymes. Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with VELCADE at reduced starting doses and closely monitored for toxicities." Velcade is indicated for the treatment of patients with multiple myeloma. Velcade also is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.  Medwatch Information

January 21 2010 - FDA notified healthcare professionals that the review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine. Based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including:

• History of coronary artery disease (e.g., heart attack, angina)
• History of stroke or transient ischemic attack (TIA)
• History of heart arrhythmias
• History of congestive heart failure
• History of peripheral arterial disease
• Uncontrolled hypertension (e.g., > 145/90 mmHg)

Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.  Medwatch Information

January 12 2010 - Wyeth notified healthcare professionals of changes to the Rapamune Prescribing Information regarding changes in the performance of an immunoassay used for therapeutic drug monitoring (TDM) of sirolimus. The TDM results reported from the assay are both assay and laboratory-dependent. In addition, the results may change over time. Therefore, adjustment to the targeted therapeutic range must be made with a detailed knowledge of the site-specific assay used. Sirolimus whole blood concentrations can be measured by either chromatographic or immunoassay methodologies. These two methodologies are not directly interchangeable and the measured sirolimus whole blood concentrations depend on the type of assay used. As such, if different assays are used in monitoring a single patient, the dose of Rapamune might be adjusted improperly with potential consequences, such as allograft rejection if drug exposure is too low or toxic side effects if exposure is too high.  Wyeth has advised healthcare providers involved in the management of patients taking Rapamune to determine: 1) which assay is being used in their laboratory(ies); 2) if there is any change to the assay used; 3) if there is a change to the laboratory’s reference range and/or a subsequent change to the institution’s or referring center’s recommended range for sirolimus. With this information, target levels can be appropriately adjusted in order to achieve optimal clinical results. It is critical that the clinician caring for a patient on sirolimus maintain communication with their laboratory to determine whether the assay used for measuring sirolimus concentrations has been changed.  Medwatch Information

January 12 2010 - Tocilizumab (Actemra by Genentech), has approved by the FDA to treat rheumatoid arthritis. Prescribing Information

January 4 2010 - Tiotropium (Spiriva by Boehinger Ingelheim) has been approved by the FDA as a treatment for reducing the symptoms of chronic obstructive pulmonary disease (COPD).  Prescribing Information

December 15 2009 - Rasagiline (AZILECT by Teva Pharmaceutical), has new FDA-approved prescribing information reducing medication and food restrictions.  Prescribing Information

December 15 2009 - Olanzapine (ZYPREXA RELPREVV by Eli Lilly and Company), has been approved by the FDA for the treatment of schizophrenia in adults. Prescribing Information

December 11 2009 - Quetiapine (Seroquel XR by AstraZeneca), has been has approved by the FDA as adjunctive treatment to antidepressants in adults with major depressive disorder, or MDD.  Prescribing Information

December 8 2009 - Olanzapine (Zyprexa by Eli Lilly), has has been approved be the FDA  in tablet form as an option for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old.   Prescribing Information

December 3 2009 - Ecallantide (Kalbitor by Dyax), has been approved by the FDA for treatment of the genetic disorder hereditary angioedema in patients 16 years and older. Prescribing Information

December 3 2009 -  GlaxoSmithKline and FDA notified healthcare professionals of a potential association between Lexiva and myocardial infarction and dyslipidemia in HIV infected adults. GSK has modified the existing Warnings and Precautions section of the Prescribing Information to note that increases in cholesterol have occurred with treatment, the importance of lipids management, and a recommendation that triglyceride and cholesterol testing be performed prior to initiating therapy with LEXIVA and at periodic intervals during therapy. The Dear Healthcare Professional letter also provides key messages, actions required by healthcare professionals and supporting information from a case-control study reported at a February 2009 international HIV conference. MedWatch Information

December 3 2009 - Sanofi-Aventis and FDA notified healthcare professionals of changes to the Warnings and Overdosage sections of the Prescribing Information for Norpramin (desipramine hydrochloride), indicated for the treatment of depression. The new safety information states that extreme caution should be used when this drug is given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances; and that seizures precede cardiac dysrhythmias and death in some patients. MedWatch Information

December 3 2009 -The FDA notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.  Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant. A valproate Medication Guide, provided with each outpatient prescription, will explain the benefits and risks of valproate and encourage patients to discuss options with their healthcare professional. Pregnant women using valproate or other AEDs should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (1-888-233-2334; www.aedpregnancyregistry.org).  MedWatch Information

December 1 2009 - Duloxetine (Cymbalta by Eli Lilly), has been approved by the FDA for the maintenance treatment of generalized anxiety disorder in adults. Cymbalta is also approved for MDD, diabetic peripheral neuropathic pain and fibromyalgia, and for the acute treatment of GAD, all in adults.  Prescribing Information