Approvals expanded for HPV and flu vaccines

Warnings, recalls, approvals.

Warnings, recalls

A warning to four companies to stop marketing unapproved codeine sulfate tablets. Another manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets.


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.

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.

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.

A recall of all size kits of Liquid Glucose Hexokinase Reagent distributed by Pointe Scientific, Inc. The reagents, catalog number G7517, have been found to fail linearity at more than 200 mg/dL which results in inaccurate glucose values above this range.

A recall of all lots of the CROSSOVER Sheath Introducer, a catheter sheath intended for use in arterial and venous procedures, due to complaints about stretching or fracture of the sheath during use.

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, 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.


Berinert, a protein product derived from human plasma, is the first approved treatment for acute abdominal attacks and facial swelling associated with a rare genetic disease called hereditary angioedema (HAE). The most serious adverse reaction reported in clinical studies was an increase in the severity of pain associated with HAE. The most common adverse reactions include subsequent HAE attack, headache, abdominal pain, nausea, muscle spasms, pain, diarrhea and vomiting.

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.

Seasonal influenza vaccine Fluarix was approved for children ages 3 years to 17 years. The vaccine, which contains inactivated influenza A and B viruses, had previously been approved for use in adults.

Pazopanib (Votrient), an oral medication that interferes with angiogenesis, was approved for people with advanced renal cell carcinoma. Patients taking the drug should receive blood tests to monitor liver function and electrolytes and periodic electrocardiograms. In clinical trials, progression-free survival averaged 9.2 months for patients receiving pazopanib compared to 4.2 months for patients who did not receive the drug.

Ofatumumab (Arzerra) was approved for patients with chronic lymphocytic leukemia (CLL). The drug, a monoclonal antibody, is meant for patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy.