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WASHINGTON - A consumer group sued the Food and Drug Administration Thursday, charging the agency is ignoring calls for stronger warnings that Cipro and similar antibiotics may cause serious tendon injuries.Labels of the fluoroquinolone family of antibiotics (buy cheap cipro online) drugs that include the popular Cipro and Levaquin — already warn about rupture of tendons and other tendon injuries, but at the bottom of a list of other side effects. The consumer group Public Citizen wants those warnings upgraded to the FDA’s most severe type, a so-called black-box warning (buy cheap cipro online) and for patients to get pamphlets with every bottle that describe the risk. It argues that too few patients know they’re supposed to quit using the drugs if they experience symptoms such as pain or inflammation, before the tendon actually ruptures. Public Citizen filed a petition seeking the stronger warning in August 2006. The state of Illinois had filed a similar petition the previous year.The FDA is violating its own statutes and putting patients at risk in taking so long to settle the issue,(buy cheap cipro online) Public Citizen said in the suit filed in U.S. District Court for the District of Columbia.When Public Citizen first filed the petition, FDA’s database showed 262 reports of tendon ruptures between November 1997 and December 2005, along with hundreds of other tendon problems in users of these antibiotics. Since then, the FDA has received an additional 74 reports of tendon ruptures, said Public Citizen’s Dr. Sidney Wolfe. Only a fraction of drug side effects typically are reported to the agency, he noted.(buy cheap cipro online)
Until now, states had generally been free to set their own Medicaid eligibility criteria, and the Bush administration had not openly declared that it would apply the August directive to Medicaid. State officials in Louisiana, Ohio and Oklahoma said they had discovered the administration’s intent in negotiations with the federal government over the last few weeks.(buy cheap cipro online)
The federal government has leverage over states, because it pays a large share of the costs for Medicaid and the State Children’s Health Insurance Program, and states have to comply with federal standards to get federal money. The insurance program was created for children whose families have too much income to qualify for Medicaid but not enough to buy private insurance.On Dec. 20, the Bush administration rejected a proposal by Ohio to expand its Medicaid program to cover 35,000 (buy cheap cipro online) more children. Ohio now offers Medicaid to children with family incomes up to twice the poverty level, or about $41,000 a year for a family of four. The state had proposed increasing the limit to three times the poverty level, to about $62,000.
“Federal officials told us that they would apply the criteria set forth in the Aug. 17 letter to our proposal for expansion of Medicaid,” said Cristal A. Thomas, the Ohio Medicaid director.Dennis G. Smith, the director of the federal Center for Medicaid and (buy cheap cipro online) State Operations, confirmed that account.“To be consistent and logical, you have to apply the criteria to Medicaid and CHIP,” Mr. Smith said in an interview.
The same concern, about the substitution of government health care for private insurance, is present under both programs, he said, and states will not be allowed to “sidestep the Aug. 17 policy directive” by expanding Medicaid.Jeff Nelligan, a spokesman for the Medicaid agency, said Ohio officials “were (buy cheap cipro online) trying to get around the Aug. 17 policy directive.” Under that policy, states had to enroll 95 percent of eligible children below 200 percent of the federal poverty level before they could expand their programs, a criterion that many state health officials said would be impossible to meet.Tony Fratto, a spokesman for President Bush, (buy cheap cipro online) defended the administration’s stance.
“We want states to focus on enrolling their neediest population before they consider expanding Medicaid and CHIP to middle-income families,” Mr. Fratto said. “This policy demonstrates the president’s compassion. He wants to direct scarce tax dollars to those with the greatest needs.”Administration officials say government health programs start to “crowd out” private insurance when they cover families with incomes from 250 percent to 300 percent of the poverty level (buy cheap cipro online) about $51,600 to $62,000 for a family of four.
Some state officials complained about both the substance of the Medicaid policy and the way it was adopted. “The Aug. 17 letter is a CHIP policy, not a Medicaid policy,” said Mike Fogarty, chief executive of the Oklahoma Health Care Authority. “But it’s being applied in a much broader way. We are seeing many more roadblocks.” The Oklahoma Legislature voted in May to cover 42,000 more children under Medicaid by increasing the income limit to 300(buy cheap cipro online) percent of the poverty level, from 185 percent. “In recent weeks,” Mr. Fogarty said, “we got a very clear signal from federal officials that we would not be allowed to go beyond 250 percent of the poverty level.”Louisiana officials reported a similar experience. “We found that we have much less flexibility to make changes in Medicaid than we thought,” said J. Ruth Kennedy, deputy director of the state’s Medicaid program.The new federal policy reflects a significant shift. In the first four years of the Bush administration, Tommy G. Thompson, the secretary of health and human services, often boasted that he had approved record numbers of waivers, allowing states to decide who got what benefits under Medicaid and the child health program.(buy cheap cipro online)