FDA responds to criticism; starts publishing quarterly Drug Safety Newsletter
WASHINGTON The Food and Drug Administration has issued a new report describing potential risks of several medicines including; the cancer drug Rituxan, the narcolepsy drug Provigil, the brain cancer medicine Temodar, and the blood infusion drug Exjade, after criticism of the agency being laidback in policing the drugs once they were on the market, according to Reuters.
The report, called the FDA’s Drug Safety Newsletter, is a response to an Institute of Medicine report criticizing the agency’s failure to follow up on approved drugs once they were on the market.
The report describes cases of serious skin reactions linked to Cephalon’s sleep disorder drug Provigil; fatal aplastic anemia seen with Schering Plough’s Temodar; and a potentially fatal central nervous system disorder associated with Genentech’s Rituxan.
The report will be published quarterly.
New York joins state lawsuits over Vioxx
NEW YORK New York has become the seventh state to file a lawsuit against Merck over its controversial painkiller Vioxx, according to a Financial Times article on MSNBC.com.
The state is alleging that the company misrepresented dangers associated with the drug and are therefore looking to recover public funds spent on prescriptions. The lawsuit is the first to be filed under the new state law, which allows damages to be rewarded of up to three times the sum spent by a state, which according to New York is more than $100 million.
“Even as evidence was piling up showing just how dangerous this drug was, Merck put profits above all else and put thousands at risk by continuing to push Vioxx inappropriately on doctors and patients,” said Attorney General Andrew Cuomo.
Recently, the New Jersey Supreme Court denied a lawsuit brought about by insurance and healthcare companies against Merck concerning Vioxx.
Rendell selects Rite Aid as site for CHIP information in Pa.
HARRISBURG, Pa. Pennsylvania Gov. Edward Rendell on Tuesday chose Rite Aid to be the conduit for information on the state’s Children’s Health Insurance Program—Rite Aid stores throughout south central Pennsylvania will host registration booths Sept. 27 from 2 p.m. to 6 p.m.
“We’re working hard to make sure every parent understands that no family earns too much for their children to be covered by CHIP,” Rendell stated. “Through Cover All Kids, CHIP is now available to thousands of uninsured children whose parents who may have earned too much to qualify for coverage under the old guidelines.”
Under the new guidelines, some families qualify for free CHIP coverage while others may receive coverage at a low cost based on family income. CHIP enrollment increased to 164,485 in September, a growth of more than 11 percent since September 2006. More than 4,200 children who are now in CHIP would not have previously been eligible.
Participating Rite Aid Store locations include: 4299 Union Deposit Rd., Harrisburg; 2604 Linglestown Rd., Harrisburg; 3601 Walnut St., Harrisburg; 1137 Market St., Lemoyne; 5277 Simpson Ferry Rd., Mechanicsburg; 40-42 West Market St., York; 3615 East Market St., York (Springettsbury); 115 Leader Heights Rd., York; 4135 North George St. Extension, York (Manchester); 1200 West Market St., York; 59 North Queen St., Lancaster; 1130 Cumberland St., Lebanon.