Panel Says Yaz Label Should Be Re-Written
In a 21 to 5 vote, the U.S. Food and Drug Administration said that the labels on certain oral contraceptive drugs should be rewritten to reflect risks accurately. The pills in question contain the hormone drospirenone. The brand names for these products include Yaz, Yasmin, Beyaz and Sayfral. Some studies suggest that the risk is higher for venous thromboembolism (VTE) in birth control pills with drospirenone than those with another hormone called levonorgestrel, a progestin. VTE occurs when blood clots …
Continue →Avastin Could Harm Fertility
Roche’s cancer drug Avastin could affect fertility in some women, the Food and Drug Administration is reporting. A new warning about “ovarian failure” has been added to Avastin’s label, and doctors are being advised to educate women of child-bearing age that Avastin may stop ovaries from releasing eggs regularly. Other updated information in the drug label includes a warning about the risk of blood clots and bleeding risk. The label also warns about possible side effects that include stroke, fatal …
Continue →J&J Settle Charge Over Risperdal
Johnson & Johnson reached an agreement in principle to settle a misdemeanor criminal charge related to the marketing of antipsychotic drug Risperdal, the company said this past week. The Justice Department and the United States attorney in Philadelphia will continue to pursue criminal and civil actions against J&J. According to the agreement in principle, J&J is guilty of a single misdemeanor violation of the Food, Drug and Cosmetic Act. The company’s Risperdal sales practices have been under investigation since 2004, …
Continue →PTSD Drug Found Ineffective
A drug used to treat post-traumatic stress disorder in veterans isn’t effective in reducing the overall severity of the condition, according to a new study in the Journal of the American Medical Association. The medication did not have a significant effect on anxiety and depression, researchers reported. The clinical trial, which took place over six months, found that the antipsychotic medication risperidone was no more effective than a placebo at preventing PTSD symptoms. Out of the 247 patients surveyed for …
Continue →FDA Announces Safety Restrictions on Cholesterol Drug Zocor
The Food and Drug Administration announced new safety restrictions on high-dose simvastatin Wednesday, after reports that the cholesterol-lowering drug could cause a muscular disease called myopathy. The risks are particularly severe in the first year of taking the medication, also known as Zocor, the agency said. No new patients should be put on a high dosage of the medication, the FDA warned. Patients currently taking the drug should only continue to do so if they have been on Zocor for …
Continue →CVS Pharmacy Settles Overbilling Case for $17.5 Million
CVS Caremark will pay $17.5 million to settle a federal lawsuit that the company overcharged Medicaid programs in Florida and other states. The company’s pharmacies overbilled the government health program, which covers low-income people, for drugs prescribed to those who also were covered by private insurance. According to the suit, the company’s pharmacy outlets overbilled individuals covered by Medicaid and other third-party insurers between October 2002 and the end of 2010. CVS agreed to pay $8 million to the federal …
Continue →Pfizer Contributes Assets to Pay Asbestos Claims
Pfizer Inc. will contribute assets to help its bankrupt, nonoperating Quigley unit pay asbestos claims. Quigley, acquired by Pfizer in 1968, made three products for the steel industry from the 1940s to the 1970s that included asbestos. Pfizer still maintains that it never made or sold any Quigley products, but some claimants haven’t released the world’s largest drug manufacturer from alleged “derivative liability.” Included in the assets Pfizer will contribute is a 281,581-square- foot building leased to a brewery. The …
Continue →New Rules to Reduce Airborne Toxins
The Obama administration recently proposed new rules to reduce mercury and other toxic emissions from power plants by 91 percent within the next five years. Congress amended the Clean Air Act in 1990 to control industrial emissions of air pollutants, but coal-fired power plants were exempt until 2000. Pollutants like lead, chromium, and arsenic can do irreparable damage to the nervous systems of children and fetuses. Additionally, airborne toxins may worsen respiratory illnesses over time. Mercury, in particular, can be …
Continue →FDA Warns: Antipsychotic Zyprexa Causes Adolescent Weight Gain
The Food and Drug Administration is again warning doctors and patients about the risks of weight gain and diabetes in children and teens prescribed the powerful antipsychotic drug Zyprexa.
Continue →Children’s Sweatshirts & Jackets Recalled Over Strangulation Hazards
Thousands of children’s sweatshirts and jackets have been recalled because the garments have drawstrings around the neck or waist, which violate federal laws and pose risks of strangulation and suffocation to kids.
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