U.S. Gives Thumbs Up to Controversial Cervical Cancer Vaccine Gardasil

They say where there is smoke, there is fire, but despite continued questions swirling around the Merck & Co. cervical cancer vaccine Gardasil, government regulators are standing firmly behind the drug.

Today, the Food and Drug Administration and Centers of Disease Control and Prevention issued a joint statement affirming their position that the benefits of the vaccine still outweigh its risks. The agencies have previously said Gardasil is safe and that reports of users suffering from fatal blood clots, seizures, fainting spells, appendicitis, allergic reactions, and a rare immune disorder known as Guillain-Barre syndrome do not overshadow the vaccine’s ability to effectively prevent cervical cancer.

“Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks,” the agencies said in a statement posted on the FDA website, according to a report in The Wall Street Journal.

Since it was approved in 2006, Gardasil has been given to more than 30 million girls and young women worldwide. In all, there have been 32 deaths linked to Gardasil, officials said.

The official government seal of approval comes on the heels of a widely report study of Gardasil, which found the vaccine can increase the risks of blood clots and fainting spells in patients who receive the series of three injections. That study was published in the Journal of the American Medical Association.

The FDA and CDC said rates of fainting and blood clots among Gardasil users may be higher than is associated with other vaccines, but not any higher than is expected in women of such ages. Also, obesity, smoking, and other factors rather than Gardasil vaccinations may have contributed to or caused those adverse events, the agencies said.

No related posts.