Showing posts with label GlaxoSmithKline. Show all posts
Showing posts with label GlaxoSmithKline. Show all posts

Thursday, September 09, 2010

Gardasil Dangers ?

Gardasil vaccine and boxImage via Wikipedia

and Cervarix are similar drugs promoted as a vaccine.

 
The drugs vary in the types of human papillomavirus () they treat, which is the virus said to cause . , manufactured by , Inc.,  is promoted as the only vaccine that helps protect against four kinds of (types 6, 11, 16 and 18), including two types that cause 70 percent of cases, and two more types that cuase 90 percent of genital warts cases.
Cervarix, manufactured by GlaxoSmithKline,  is not currently available in the United States, but was approved for use in the U.S. by the FDA on October 16, 2009, and is expected to enter the market here by late 2009. It is already approved for use in Australia, the Phillipines and the European Union. It is used in the UK for a national program of vaccination for teen and pre-teen girls to target two types of (types 16 and 18) for the prevention of and pre-cancers.

Both and Ceravix are marketed to be given to girls and young women as young as age 9, and up to age 26.

Since ’s introduction in 2006, the (VAERS) has received more than 15,000 reports of adverse side effects related to . These reports include serious adverse 
side effects including Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. There also have been 44 reported deaths as a result of uses.

Cervarix has been linked to more than 2,000 cases of serious, adverse reactions since the UK government began administering it to schoolgirls last year. One of the worst cases involved 14-year-old Natalie Morton, who collapsed and died in school in England just one hour after receiving the vaccine.

Then, on October 25, 2009, Dr. Diane Harper, lead researcher in the development of two human papilloma virus () vaccines and director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, told an audience of medical professionals that is largely unnecessary, and that it has never been fully tested on females under the age of 15. This, despite strong marketing efforts to make the drug mandatory for girls, and product literature and advertising that state the product can be used by girls as young as age 9.

On Oct. 16, 2009, the same day GlaxoSmithKline got approval to market its Cervarix drug in the U.S. the FDA also granted approval to to expand the use of in the U.S. to treat boys and men ages 9-26 for the prevention of genital warts.

Ad in the United States, and is recommended for girls and women ages 9-26 by manufacturer , Inc.

In February 2009, the National Vaccine Information Center, a private vaccine-safety group, conducted a comparative study of adverse events reported following a Menactra (meningococcal) vaccine versus the vaccine.  Both vaccines are recommended for youngsters in the same age group, at 11-12 years old (Menactra for boys and girls, for girls only). The study compares data reported for each vaccine.

The study found that is associated with at least twice as many Emergency Room visit reports, four times more death reports, five times more “did not recover” reports, and seven times more “disabled” reports, as compared to Menactra.
Other findings of this study show that compared to Menactra:
  • is associated with all reports of blood clots
  • is associated with at lest four times as many cardiac arrest reports
  • is associated with at least six times as many fainting reports
  • is associated with at least four times as many Lupus reports
  • is associated with at least 15 times as many stroke reports


Tuesday, March 30, 2010

Saudi Government Bans Avandia (Georgia/Florida)

Saudi Arabia has suspended GlaxoSmithKline PLC's (GSK) diabetes drug Avandia for six months, saying the product's heart risks outweigh its benefits, but the U.K.-based drug maker said its stands by the controversial drug.

The Saudi Food and Drug Authority said on its website that the risk of using Avandia, also known as rosiglitazone, "outweighs its benefit, especially risks of cardiovascular events including myocardial infarction and congestive heart failure in addition to increased risk of fractures."

It said safer alternatives could be used there instead.

Glaxo responded by saying "the Saudi regulatory authority action is based on a review that did not include the most recent scientific data on Avandia."

"GlaxoSmithKline stands behind the safety and efficacy of Avandia when used appropriately and according to its label and maintains that this is an important medicine for the treatment of type 2 diabetes."

Glaxo now has six months to provide the Saudi drug regulator with evidence of why rosiglitazone and combination products containing it should not be taken off the Saudi market permanently. Rosiglitazone containing products marketed in Saudi Arabia are Avandia , Avandamet and Avandaryl.

http://online.wsj.com/article/BT-CO-20100322-710067.html?mod=WSJ_latestheadlines

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