FDA & Prescription Drugs | InjuryBoard New York City

Fosamax also know by its generic name Alendronate may be linked to a bone disease called Osteonecrosis of the Jaw (ONJ). Fosamax is manufactured by Merck, and gained FDA approval in 1995. It is prescribed to treat osteoporosis and Paget's disease. . Individuals using Fosamax or other bisphosphonates should attempt to steer clear of tooth extractions and other major dental work while on the...

The warning from Johnson and Johnson, makers of Ortho Evra patch, states that the patch exposes women to 60 percent more estrogen than daily birth control pills. Interestingly, Ortho Evra is the first and only skin patch approved for birth control, and more than 4 million women have used the patch since it came on the market three years ago. Johnson and Johnson have reaped huge profits off of...

The Public Citizen has petitioned the U.S. Food and Drug Administration (FDA) to immediately begin to phase out the widely prescribed pain reliever propoxyphene (Darvon, Darvocet and generic versions) from the market because the drug has been associated with more than 2,000 accidental deaths, is physically addictive and is no more effective than safer alternatives.

Bristol-Myers Squibb is warning against the use of the antibiotic drug Tequin in diabetic patients after reports of several fatalities per the FDA. The company has also said its adding a contraindication warning for diabetics to the drug's label as well as strengthening its warning that Tequin can cause both low and high blood sugar levels in patients. Bristol-Myers spokesman Eric Miller said...

The Food and Drug Administration (FDA) announced on November 11, 2005 that the Ortho Evra contraceptive patch exposes millions of women who use the patch to levels of estrogen far higher than most daily birth control pills, putting them at higher risk for blood clots than previously disclosed. The FDA also approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare...

The long-term use of warfarin, a drug commonly prescribed to reduce the risk of blood clots, appears to increase the risk of fractures associated with osteoporosis, a bone-thinning condition that usually increased with age, according to a report. As the study authors note, warfarin prevents coagulation by blocking vitamin K, which is needed to activate certain clotting factors. Because vitamin K...

Letters from the editor of the New England Journal of Medicine were introduced as evidence in a federal trial against painkiller Vioxx. The e-mail messages written to another scientist express concern with a study that may have left out crucial data on the harmful effects associated with the drug. The dispute is over VIGOR, a study which has been faulted by plaintiffs for failing to disclose...

A report being published in The New England Journal of Medicine found that the heart surgery drug aprotinin, sold as Trasyol, poses unnecessary risks to patients and should be replaced by safer alternatives. Doctors found that the blood-clotting medication can cause kidney failure and increase the prevalence of heart attacks and strokes. Bayer disputes the finding, which will be reviewed by the...

A federal judge decided that top drug manufacturers must face a class-action lawsuit from consumers who claim they were overcharged for prescription medication. Johnson & Johnson, Bristol-Myers Squibb Co., AstraZeneca Plc and GlaxoSmithKline Plc have all been named as defendants. Drug companies set prices based on the Average Wholesale Price formula, which is used to reimburse federal health...

Last week, the FDA approved two new warnings on the labeling for two skin care drugs, Elidel and Protopic. Although a causal link between these two topical drugs and certain cancers has not yet been established, patients receiving these drugs have reported a higher incidence of cancers, namely skin cancer and lymphoma. Patients taking these drugs are encouraged to consult with their doctor to...

Johnson & Johnson, Bristol-Myers Squibb Co., AstraZeneca PLC and GlaxoSmithKline PLC must face a class-action lawsuit from consumers who say they were harmed by the way the companies charged for their drugs, a judge said Thursday. Federal Judge Patti B. Saris in Boston said she will certify a nationwide class action for people who paid even a small portion of the cost of the companies'...

Serevent, a widely prescribed inhaled asthma treatment, may pose a special risk to african americans.Newly released details from a safety trial that was stopped early reveal that respiratory-related deaths or life-threatening events occurred four times as often among blacks who took Serevent than among blacks who did not take the drug.The findings, first reported to the U.S. Food and Drug...

A warning from U.S. regulators linking GlaxoSmithKline Plc's diabetes drug Avandia to rare cases of swelling in the back of the eye is unlikely to have a major impact on sales, analysts said on Friday.The Food and Drug Administration highlighted the problem in a notice late on Thursday after the drug maker said it had received "very rare" reports of the swelling, known as macular oedema, in...

TheFood and Drug Administration and manufacturer GlaxoSmithKline have stated that patients taking two widely used diabetes drugs have reported blurry vision and swelling of the legs and feet. Thursday. The company said it has received "very rare" reports of new or worsening diabetic macular edema in diabetic patients who have taken Avandia or Avandamet. The swelling of the portion of the retina...

ORTHO EVRA birth control is a weekly birth control patch that was introduced into the market in November 2001. In 2004, ORTH EVRA accounted for more than 9.9 million prescriptions with sales topping a staggering $411 million. However, in November 2005, the FDA issued a black box warning label for the ORTHO EVRA birth control patch. Black box warnings are designed to highlight special problems,...