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GSK 63 articles

Is Zofran’s popularity due to illegal marketing? Are there better alternatives you’ve never heard of?

A blogger at Baby Center Community recently shared information about another drug to prevent nausea and vomitng during pregnancy besides Zofran with mothers who might be concerned considering all the recent litigation surrounding Zofran allegedly causing birth defects, specifically cardiac septum defect. She recommends Kytril, saying that, “During its approval process, Kytril was shown to eliminate vomiting 88 percent of the time compared to 62 percent with Zofran. It also eliminated nausea 63 percent of the time with a lower incident rate of constipation and headaches.” She says that she personally has had a better experience with the drug than she did with Zofran during her first pregnancy. ... Read More

Parents lock horns with GSK over Zofran birth defects lawsuits

Drugmaker GlaxoSmithKline’s motion to dismiss more than 200 birth defects claims with its anti-nausea drug Zofran were met with strong objections from the parents who said animal studies support their allegations that use of the drugs by women during pregnancy can lead to birth defects in their offspring. The families argued to U.S. District Judge F. Dennis Saylor IV that no discovery has been undertaken in the cases and that GSK would have no control over any relevant evidence of birth defects risks in pregnant women since the drug has never been approved to treat morning sickness. Zofran is approved ... Read More

Woman claims nausea drug Zofran caused birth defects

An Arkansas mother is suing the makers of the anti-nausea drug Zofran claiming the medication caused her son to be born with multiple birth defects. Jody Huffmaster filed her lawsuit in the U.S. District Court for the Eastern District of Louisiana against GlaxoSmithKline (GSK), maker of Zofran. The medication contains the drug ingredient ondansetron and is approved by the Food and Drug Administration (FDA) to treat nausea during chemotherapy and following surgery. Between 2002 and 2003, GSK began promoting the drug as a treatment for morning sickness even though there were no controlled studies to prove the drug was safe ... Read More

GSK recalls thousands of 4-in-1 flu vaccinations

GlaxoSmithKline (GSK) is recalling its four-in-one flu shot over concerns that it can lose its effectiveness over time and fail to adequately protect against some strains of the flu. The recall affects the Flualval Quadrivalent Thimerosal-free vaccine in prefilled syringes. GSK sent a letter to roughly 1,000 U.S. wholesale distributors, pharmacies, government agencies and physicians saying it “cannot rule out potential suboptimal protection” for people who received the vaccine in early January or later. About 1.7 million doses are affected by the recall, which represents about 7 percent of the 24 million flu shots GSK distributed this flu season. GSK’s ... Read More

Experimental vaccine helps extend life of brain cancer patients

An experimental cancer vaccine helped patients with one of the most common malignant brain tumors live almost twice as long as patients who received the standard treatment of care. Glioblastoma multiforme, or GMB, is one of the most aggressive malignant brain tumors. The tumors arise from astrocytes, star-shaped cells that make up the supportive tissue of the brain. They are highly malignant because the cells reproduce quickly and are supported by a large network of blood vessels. GMB is the same tumor that affected the late Sen. Ted Kennedy. Most people with a GMB die within one year of diagnosis ... Read More

GSK pays $22 million to settle fraudulent marketing claims in West Virginia

GlaxoSmithKline (GSK) has agreed to pay $22 million to settle claims that the pharmaceutical company used illegal tactics to peddle its diabetes drugs. The settlement is one of the largest in West Virginia history, said Attorney General Patrick Morrisey. About $10.6 million will go to the state’s Public Employees Insurance Agency and $3.7 million to the Department of Health and Human Services’ Medicaid program. About $3.1 million will go to the attorney general’s Consumer Protection Fund and the remaining $4.6 million will be used to cover attorney’s fees and expenses. Morrisey, on behalf of West Virginia, argued that GSK failed ... Read More

GSK to pay $105 million to settle claims it unlawfully promoted drugs

GlaxoSmithKline (GSK) has reached a $105 million agreement with 44 states and the District of Columbia to settle lawsuits alleging the drug company marketed some of its drugs for unapproved uses. The settlement also requires GSK to pay a hefty penalty and submit to strong new rules designed to prevent future misrepresentations. GSK did not admit any wrongdoing or liability under the settlement. The arrangement is similar to one GSK reached with the federal government two years ago, in which the company agreed to pay $3 billion to settle criminal and civil claims involving illegal marketing of its asthma drug ... Read More

FDA approves new type 2 diabetes drug Tanzeum

After a three-month delay, the Food and Drug Administration (FDA) has approved GlaxoSmithKline’s new type 2 diabetes treatment, albiglutide. The drug will be marketed in the United States as Tanzeum. The FDA had initially planned to make a decision on Tanzeum in January, but pushed the deadline back three months to allow more time to review risks and benefits of the drug. Tanzeum is a subcutaneous injection to improve glycemic control along with diet and exercise. It is indicated as a monotherapy in patients with type 2 diabetes for whom the widely used metformin is considered inappropriate, and as an ... Read More

Batches of Paxil recalled due to possible contamination

GlaxoSmithKline (GSK) received a warning letter from the Food and Drug Administration (FDA) regarding a potentially contaminated shipment of the company’s antidepressant Paxil and its failure to warn consumers of quality problems. The action stems from an October inspection of its plant in Ireland during which the FDA found several violations of good manufacturing practices. GSK announced it will issue a Class III recall of Paxil made at the facility in question, meaning it is of less serious nature. The company says the issue is nothing consumers should be concerned about and that they believe there is no risk for ... Read More

Alli weight loss pills recalled due to potential tampering

GlaxoSmithKline (GSK) is recalling all of its Alli weight loss products in the United States and Puerto Rico after numerous reports across several states that packages may have been tampered with and may contain counterfeit pills. GSK received reports from customers in seven states that bottles of Alli tablets and capsules were not Alli. The counterfeit pills inside the bottles were in various shapes and colors. Some of the bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. All of the tampered with products were purchased in retail stores. Alli is an over-the-counter ... Read More