FDA Turns Down Merck's Bid To Get Gardasil Approved as an HPV Vaccine for Women 27 and Older

May 13, 2011,

The US Food and Drug Administration recently turned down an application by Merck to approve Gardasil as a vaccine against the human papillomavirus for women 27 and older. The FDA says it wants the pharmaceutical company to include a statement on its vaccine label noting that the drug isn't proven to prevent HPV-linked complication in women over 26.

Gardasil protects against the four HPV strains that are most likely to cause genital warts and cervical cancer. It also is supposed to cancers of the vagina and vulva, as well as anal cancer in both sexes. In 2006, the drug was approved for use by females, ages 9 to 26. In 2009, the vaccine was approved for males in the same age range. That said, our Anaheim products liability lawyers would like you to be aware that serious side effects can result from using this vaccine.

Since 2006, the Vaccine Adverse Event Reporting System has received over 15,000 reports of adverse effects, including at least 44 deaths.

Other possible Gardasil side effects:
• Seizures
• Optic lesions
• Spontaneous abortion
• Guillain-Barre Syndrome
• Paralysis
• Convulsions
• Anaphylactic shock
• Coma
• Blood clots
• Miscarriage

Merck has taken aggressive steps to market the drugs so that parents would make sure their daughters receive the Gardasil vaccine. Yet some of the health complications reported have occurred to young girls and teenagers.

Our Anaheim personal injury law firm represents clients who suffered health complication from taking Gardasil and other vaccines and medications. Drug makers should be held liable for drugs that prove dangerous for use. They also can be held responsible for failing to warn of side effects.

FDA: Gardasil not effective in women 27 or older, Consumer Reports, April 8, 2011


Related Web Resources:
Gardasil

Reports of Health Concerns Following HPV Vaccination, CDC

Human papillomaviruses and Cancer, National Cancer Institute

Food and Drug Administration


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