Johnson & Johnson Wins Zero Verdict Over Levaquin's Side Effects

Johnson & Johnson on Friday won a significant lawsuit concerning whether it adequately alerted doctors to the risks in prescribing Levaquin.

J & J is facing more than 2,000 lawsuits from plaintiffs who claim the company was slow in fully warning doctors about reports linking Levaquin to tendonitis and tendon ruptures. In a New Jersey state court in Atlantic City, lawyers for the drug maker told jurors that the Levaquin label had included information about tendon problems since the FDA approved the drug in 1996.

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Gardasil Dangers ?

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Gardasil and Cervarix are similar drugs promoted as a cervical cancer vaccine.

 
The drugs vary in the types of human papillomavirus (HPV) they treat, which is the virus said to cause cervical cancer. Gardasil, manufactured by Merck, Inc.,  is promoted as the only cervical cancer vaccine that helps protect against four kinds of HPV (types 6, 11, 16 and 18), including two types that cause 70 percent of cervical cancer 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 HPV (types 16 and 18) for the prevention of cervical cancer and pre-cancers.

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

Since Gardasil’s introduction in 2006, the Vaccine Adverse Event Reporting System (VAERS) has received more than 15,000 reports of adverse side effects related to Gardasil. 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 Gardasil 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 (HPV) vaccines and director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, told an audience of medical professionals that Gardasil 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 Merck to expand the use of Gardasil 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 Merck, 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 Gardasil vaccine.  Both vaccines are recommended for youngsters in the same age group, at 11-12 years old (Menactra for boys and girls, Gardasil for girls only). The study compares VAERS data reported for each vaccine.

The study found that Gardasil 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:

• Gardasil is associated with all reports of blood clots
• Gardasil is associated with at lest four times as many cardiac arrest reports
• Gardasil is associated with at least six times as many fainting reports
• Gardasil is associated with at least four times as many Lupus reports
• Gardasil is associated with at least 15 times as many stroke reports

FDA Drug Safety Communication: New Boxed Warning on severe liver injury with propylthiouracil

The United States Food and Drug Administration (FDA) has added a Boxed Warning to the label for propylthiouracil, a drug used to treat hyperthyroidism (overactive thyroid), to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients using this medication.

The new warning also states that for patients being started on treatment for hyperthyroidism it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine or surgery. In addition, due to the occurrence of birth defects that have been observed with the use of methimazole during the first trimester of pregnancy (see Data Summary), propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.

Propylthiouracil has been shown to be effective in reducing thyroid hormone levels and decreasing symptoms associated with hyperthyroidism. However, to help patients understand the known benefits and potential risks of this medication, as part of a Risk Evaluation and Mitigation Strategy (REMS), FDA is requiring that a Medication Guide be given to every patient filling a prescription for propylthiouracil.

The recommendations in the Boxed Warning and the requirement of a Medication Guide are based on FDA's review of post-marketing safety reports of propylthiouracil (see Data Summary) as well as meetings with the American Thyroid Association, the National Institute of Child Health and Human Development, and the pediatric endocrine clinical community.

Source: http://bit.ly/dBQZVY

Gov't Panel seeks Blackbox Warning for MRI Drugs

MRI imaging drugs from GE Healthcare (GE.N) and Covidien (COV.N) appear linked to a higher risk of a potentially fatal skin disease for some patients than similar products.

'A majority of the Food and Drug Administration panel felt current data showed GE's Omniscan and Covidien's Optimark were associated with a higher risk of nephrogenic systemic fibrosis (NSF) for patients with severe kidney disease, panel chairman Robert Harrington said.' Source.

Nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. Its cause is not fully understood, but it seems to be associated with exposure to gadolinium (which is frequently used as a contrast substance for MRIs) in patients with severe kidney failure. It does not have a genetic basis.

In NSF, patients develop large areas of hardened skin with fibrotic nodules and plaques. Flexion contractures with an accompanying limitation of range of motion can also occur. NSF resembles scleromyxedema at the histologic (microscopic) level; it shows a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and deposits of mucin.

A black box warning is a notice on the packaging of a prescription drug which warns patients and prescribers that the drug has potentially dangerous side effects. This warning system is primarily used by the Food and Drug Administration (FDA), an American regulatory agency which oversees the safety of pharmaceuticals produced and sold in the United States. Other national regulatory agencies may use different systems to indicate that drugs are potentially dangerous.

When a drug receives a black box warning, it means that studies on the drug have suggested that it can have dangerous or even deadly side effects. Black box warnings are often added retrospectively as the result of information about a drug which has been uncovered in the course of routine usage. When doctors start reporting high levels of dangerous side effects for a prescription drug, the FDA may hold a review to decide whether or not the drug requires a black box warning.

The “black box” in “black box warning” refers to the bold black border which is drawn around the warning. The border is designed to draw attention to the warning, and to offset it from other information which may be present in pharmaceutical packaging. Thanks to widespread public awareness of the implications of a black box warning, a black box on drug packaging serves as an alert that the drug is dangerous even before people read the text of the warning.