New Vaccine to Prevent Cervical Cancer
The FDA approved Merck's Gardasil, the first vaccine designed to prevent cervical cancer, precancerous genital lesions, and genital warts due to human papillomavirus (HPV) types 6, 11, 16, and 18. The new vaccine is approved for use in females 9 to 26 years of age.
The recombinant vaccine is given as three injections in the upper arm over a 6-month period. Immunization with Gardasil is expected to prevent most cases of cervical cancer due to HPV types included in the vaccine. However, girls and women who have been infected with that HPV type prior to vaccination are not protected. The vaccine also does not protect against less common HPV types not included in the vaccine.
The FDA based its approval on the results of four studies conducted in 21,000 women. The results showed that in women not already infected, Gardasil was nearly 100% effective in preventing precancerous cervical lesions, precancerous vaginal and vulvar lesions, and genital warts caused by infection with the HPV types against which the vaccine is directed. The FDA notes that while the studies did not last long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed to be highly likely to result in the prevention of those cancers.
ACE-Is Associated with Congenital Malformations
A recent study reported that infants whose mothers had taken an angiotensin-converting enzyme (ACE) inhibitor medication during the first trimester of pregnancy had an increased risk of major congenital malformations compared with infants who had not been exposed to ACE inhibitor drugs in the first trimester.
The current labeling of ACE inhibitors recommends discontinuing ACE inhibitors as soon as possible if a patient becomes pregnant. Angiotensin-converting enzyme inhibitors are in pregnancy category C for the first trimester of pregnancy, and are labeled pregnancy category D during the second and third trimesters.
The FDA does not intend to change the pregnancy categories for ACE inhibitors based on the results of this one study, but will be working with other government agencies to determine the degree of risk associated with first trimester exposure to these drugs.
Recall of Ultilet and Closercare Insulin Syringes
An earlier recall of Ultilet insulin syringes has been extended and an additional recall of Closercare insulin syringes has been made because of bacterial contamination with Paenibacillus.
According to the FDA, this contamination presents risk of local infection due to soft tissue injection with a contaminated syringe as well as a risk of introduction of contaminating organisms into a previously sterile vial. The introduced contamination may degrade the insulin, leading to problems maintaining insulin levels.
The recall includes Closercare Insulin Syringe 29 grams 1-mL, product lot number 5JCZ1 and Ultilet Insulin Syringe 30 grams 1/2-mL, product lot number 5KEO1.
Medication Approved for Prevention of SAD
Bupropion extended-release tablets (Wellbutrin XL) are now approved for the prevention of major depressive episodes in adults with a history of seasonal affective disorder (SAD). It is the first and only medication approved for this disorder. Bupropion was previously approved for treatment of major depressive disorder.
The effectiveness of bupropion extended-release for the prevention of SAD episodes was shown in three double-blind, placebo-controlled trials in adults with a history of major depressive disorder in autumn and winter. Treatment was started prior to the onset of symptoms in the autumn and was discontinued following a 2-week taper that began the first week of spring. In these trials, the percentage patients who were depression-free at the end of treatment was significantly higher for those on bupropion extended- release than for those on placebo.