Daily Archives: February 23, 2012

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More birth defects lawsuits filed against Zoloft makers

More lawsuits have been filed against drug maker Pfizer by women who claim that the company hid information that showed using the antidepressant Zoloft during pregnancy could cause birth defects. The class action lawsuit was filed in St. Louis Circuit Court against Pfizer. The women claim they were prescribed Zoloft during their pregnancies despite the alleged risks to their unborn children. The woman say their children were later born with several birth defects, including damage to their hearts. Zoloft is in a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Other brand name medications in this class ... Read More

FDA panel recommends approval of controversial diet drug Qnexa

A new diet drug may soon be available for people battling the bulge, but it may come at a price. This week, a Food and Drug Administration (FDA) advisory panel reviewed clinical data on the weight loss drug Qnexa and voted to recommend its approval despite rejecting its application a year ago due to serious health concerns. The FDA is expected to make a final ruling about the drug later this year, but the agency typically follows the recommendations of its advisory panels. If approved, Qnexa will be the first prescription diet pill to hit the United States market since ... Read More

BP, Anadarko will pay civil penalties for oil spill, judge rules

BP and minority partner Anadarko Petroleum Corp. will have to pay civil penalties for violations of the Clean Water Act that led to the massive Gulf of Mexico oil spill, U.S. District Judge Carl Barbier, who is presiding over BP oil-spill litigation, ruled Wednesday. The fines are calculated on a per-barrel basis and will be determined at a later date. According to the Clean Water Act, fines can range from $1,100 per barrel of oil spilled to $4,300 per barrel, with the higher charges levied should gross negligence be ruled a factor in the cause of the oil spill. Additionally, ... Read More

Memo reveals DePuy knew its hip implants were defective but continued to sell them

Top executives for Johnson & Johnson subsidiary DePuy Orthopaedics had evidence that one of the company’s all-metal artificial hip devices was failing prematurely in patients a year before the device was recalled, but withheld this information and continued to market the device. The evidence is found in an August 2009 email sent to three top executives at DePuy from a vice president at the company regarding another hip device. The company had sought approval from the Food and Drug Administration (FDA) for its ASR hip implant used for a relatively new hip replacement procedure called resurfacing. Typically, the vast majority ... Read More

Consumer group lobbies for stricter oversight of medical devices

Consumers Union (CU) is joining the fight to urge lawmakers to require stricter oversight of medical devices, especially since it says the current practice puts consumers, especially senior citizens, at risk for ongoing complications. CU is a nonprofit consumer watchdog that also publishes Consumer Reports magazine and ConsumerReports.org. The Food and Drug Administration (FDA) is charged with protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; and human and veterinary drugs, vaccines and other biological products and medical devices intended for human use are safe and effective. Foods are regularly checked, and drugs must ... Read More

Gulf states are one step closer to acquiring BP oil-spill fines

Legislators from the Gulf States are one step closer to making sure billions of dollars in oil-spill fine money collected from BP’s violations of the Clean Water Act will go to the Gulf Coast states rather than into the federal government’s general fund. The House gave approval last week to an amendment that would apportion 80 percent of the fine money to the Gulf States directly harmed by the disastrous 2010 oil spill, but they are still in a race against the clock to make sure the amendment gets Senate approval before the oil-spill fines are determined and collected in ... Read More

FDA considers approval of diet drug despite birth defects, heart risks

Drug maker Vivus Inc., is hoping to win Food and Drug Administration (FDA) approval for its diet drug Qnexa this week after a rejection in 2010 due to serious health concerns. Experts say the chances of the weight loss drug being cleared are 50-50. Qnexa is a combination of two FDA-approved drugs. One is phentermine, the “safer” part of the fen-phen diet drug that was banned due to heart problems. The other active ingredient is topiramate, a drug used to treat seizures and migraines. Topiramate has side effects that include suicidal thoughts and birth defects. The FDA rejected Qnexa its ... Read More