PHARMACY

J&J settles lawsuit over Ortho Evra

BY Allison Cerra

RARITAN, N.J. Ortho Evra manufacturer, Johnson & Johnson, recently settled a lawsuit with the family of a 14-year-old girl killed by the defective birth control patch.

According to Bloomberg reports, the family was paid approximately $1.25 million for the death of 14-year-old Alycia Brown, who died in May 2004 from two blood clots in her lungs that developed after she had been using the Ortho Evra birth control patch for several weeks.

The case is just one of 2,000 Ortho Evra lawsuits.

Ortho Evra was introduced in 2002 as a weekly contraceptive patch. In 2005, the Food & Drug Administration discovered and warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who used oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries.

After publishing the warning, the FDA received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then in 2006, a study was published that showed women using the contraceptive patch were twice as likely to suffer blood clots as those taking oral birth control pills. That study impelled the FDA to request a change on the Ortho Evra label to include a stronger safety warning.

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PHARMACY

FDA approves supplemental NDA for Januvia

BY Allison Cerra

WASHINGTON The FDA approved a supplemental new drug application for Merck’s Type 2 diabetes drug Januvia, citing new uses and additional warnings.

The pharmaceutical company, which produces several heart-related medications, had received feedback from patients taking Januvia (sitagliptin) experiencing health problems including anaphylaxis, angioedema and undesirable skin conditions. There had been reports that patients experienced the potentially fatal skin condition known as Stevens-Johnson Syndrome.

Januvia’s revised labeling will now indicate that patients with a history of hypertension should not use the drug. The company said, however, it could not establish a causal relationship to the drug or reliably estimate the frequency of the side effects.

The updated labeling additionally states that Januvia can be used as an initial therapy or add-on therapy with other medications, including metformin and sulfonylurea.

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House Dems push through revised SCHIP, but GOP claims partisanship

BY Allison Cerra

WASHINGTON The House of Representatives approved a new version of legislation to expand the State Children’s Health Insurance Program yesterday, but the vote failed to get any more Republicans to override another promised veto from President Bush.

Democratic leaders decided the new revision would state the exclusion of illegal immigrants from the program, which would motivate state governments to drop families earning more than 300 percent of the poverty line, which will ultimately force adults off of the program.

Under both versions, the combined average monthly enrollment in SCHIP and Medicaid would be about 34.1 million people, according to the Congressional Budget Office. But there is a shift toward serving poorer children, a key Republican demand. In the new bill, Medicaid enrollment alone would be about 400,000 individuals higher than under the vetoed bill, while SCHIP enrollment would be about that much lower, according to CBO documents.

Almost half of the 3.9 million uninsured children projected to gain coverage under the revised bill, of whom about 80 percent live below the poverty level, would be covered under Medicaid, said Genevieve Kenney, an Urban Institute health economist.

According to The Washington Post, the 265 to 142 tally included 43 Republicans, two fewer than the version that passed Sept. 25.

Republicans called for a postponement of the vote due to the absence of nine members House touring the wildfire disaster in California, but Speaker Nancy Pelosi, D-Calif., insisted she had no choice but to move forward and give the Senate a chance to send the measure to Bush next week. “If Republicans believe in SCHIP as they say they do . . . then they won’t be looking for an excuse to vote against the bill,” Pelosi said.

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