Ketorolac, Liposyn recalled for particulate contamination

Recalls, warnings

A recall of ketorolac tromethamine injection manufactured by American Regent because of a potential for particulate matter in the product. The affected concentrations are 15 mg/mL, NDC# 0517-0601-25 (15 mg/mL 1 mL single-dose vial), and 30 mg/mL, including NDC# 0517-0801-25 (30 mg/mL 1 mL single-dose vial) and NDC# 0517-0902-25 (30 mg/mL 2 mL single-dose vial [60 mg/2 mL]). Use of the product could result in adverse events such as obstruction of blood vessels, foreign body granulomas and local irritation at the injection site.

A class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, manufactured from August 2008 through August 2009 and distributed from November 2008 through September 2009, because the balloon catheters may spontaneously rupture during surgery.

A recall of Liposyn II and III and Propofol Injectable Emulsion because some may contain particulate matter that impedes blood flow, which could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death. The recall comprises 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80, distributed between July and October of 2009.

A warning that five medications for rare diseases made by Genzyme Corporation may be contaminated by foreign particles. The affected medications include all of the following products with lot numbers that start with “A” (e.g., Lot A12345): imiglucerase (Cerezyme), agalsidase beta (Fabrazyme), alglucosidase alfa (Myozyme), laronidase (Aldurazyme) and thyrotropin alpha (Thyrogen).

A modification of the boxed warning for iron dextran injection (Dexferrum) because anaphylactic-type reactions, including fatalities, have followed its parenteral administration. The new labeling recommends administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of the drug. Fatal reactions have followed the test dose of iron dextran injection, even in situations where the test dose was tolerated, the FDA warned.

An expanded recall of Accusure insulin syringes due to the possibility that needles may detach from the syringes. Certain lots of the syringes were recalled in August, but the recall has expanded to all syringes distributed between January 2002 and October 2009, regardless of lot number.

Removal of the COBAS AmpliPrep/COBAS Amplicor HIV-1 monitor test because the QS copy number was incorrectly designated as 107 copies/PCR instead of 97 copies/PCR.

Revisions to the label for exenatide (Byetta) to include post-marketing reports of altered kidney function, including acute renal failure and insufficiency. From April 2005 through October 2008, the FDA received 78 reports (62 cases of acute renal failure and 16 cases of renal insufficiency) about patients using the incretin mimetic. Some cases occurred in patients with pre-existing kidney disease or with one or more risk factors for developing kidney problems.

Approvals

Romidepsin (Istodax) to treat patients with cutaneous T-cell lymphoma (CTCL). The drug is meant to be used when CTCL gets worse or comes back after at least one other type of chemotherapy has been used. Side effects of romidepsin may include nausea, fatigue, infections, vomiting, decreased appetite, decreased red blood cell count, decreased platelet count and decreases in the components of white blood cells. Blood tests and, in some patients, electrocardiograms may be required for monitoring.

Tranexamic acid tablets (Lysteda), the first non-hormonal product to treat heavy menstrual bleeding (menorrhagia). The drug was approved by the FDA in 1986 as an injection to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia. Use of the drug while taking hormonal contraceptives may increase the risk of blood clots, stroke, or heart attack, so women using hormonal contraception should take it only if there is a strong medical need.

Expanded use of CSL Limited's seasonal and 2009 H1N1 influenza vaccines to include children ages 6 months and older and seasonal influenza vaccine Fluarix to include children ages 3 years to 17 years. These vaccines were previously approved for use in adults.

Gardasil, the human papillomavirus (HPV) vaccine, was approved for the prevention of genital warts (condyloma acuminata) due to HPV types 6 and 11 in males ages 9 through 26. Another HPV vaccine, Cervarix, was approved to prevent infection from HPV types 16 and 18 in females ages 10 through 25. Both vaccines are given as three injections over a six-month period. Headache, fever and pain at the injection site, itching, redness, swelling and bruising, fatigue, muscle and joint aches, and gastrointestinal distress were the most common side effects observed.

Miscellaneous

The FDA is investigating energy levels in external biphasic defibrillators with shocks <200 J due to 14 reports of the devices being ineffective. In the 14 events, a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion. The agency doesn't recommend any changes to clinical practice at this time and is seeking additional information in order to interpret the significance of these 14 events.

A reminder not to use local anesthetics as continuous intra-articular postoperative infusions after 35 reports of chondrolysis in patients given continuous intra-articular infusions with elastomeric infusion devices to control post-surgical pain. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion, and in more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty.