Merck, FDA Update Potential Adverse Reactions To HPV Vaccine Gardasil, Washington Times Reports

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology;  Regulatory Affairs / Drug Approvals
Article Date: 14 Jul 2008 - 7:00 PDT

email to a friend   printer friendly   opinions  

The Washington Times on Thursday reported that Merck and FDA last month added potential adverse reactions to Merck's human papillomavirus vaccine Gardasil to the package insert and information sheet given to patients. The potential adverse reactions include joint and muscle pain, fatigue, physical weakness and "general malaise," according to the Times.

According to a report released last month by the conservative, nonpartisan group Judicial Watch, a government database had received 8,864 reports of potential adverse events as of June 10 from the vaccine since FDA approved it in 2006. CDC spokesperson Curtis Allen said government and Merck officials look at all reports of adverse events to look for patterns, adding, "From the data we have seen to date, the vaccine is safe and effective."

FDA spokesperson Karen Riley said that the updated information on potential adverse reactions has "nothing to do" with reports of possible serious reactions to the vaccine, adding that the update was made at Merck's request to address potential "mild" symptoms. "The bottom line is that we have not seen any safety signals in the adverse events other than" fainting, Riley said, adding, "We continue to look at these reports." Merck spokesperson Amy Rose said that she does not have "any reason to believe" the changes are "anything other than a routine update." Tom Fitton, president of Judicial Watch, said that the group is "not convinced" that the government is "taking these reports seriously" and is calling for "further investigation of its safety" (Washington Times, 7/10).

According to Merck, 11,000 girls and women received the vaccine before it was approved, and 16 million doses have been distributed in the U.S. since approval (Fagan, Washington Times, 7/10). Gardasil in clinical trials has been shown to prevent infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and to prevent infection with HPV strains 6 and 11, which cause about 90% of genital warts cases (Daily Women's Health Policy Report, 7/8).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2008 The Advisory Board Company. All rights reserved.

• Additional
• References
• Citations