Feb 19, 2006 - The FDA conceded findings of a new study indicating women using the Ortho Evra birth-control patch have twice the risk of developing blood clots than those taking birth-control pills. After years of debate, Ortho-McNeil recently admitted that women who use the product are at an increased risk of blood clots, stroke and death.   Read More

Feb 9, 2006 - A study in the NEJM noted a 6 fold increase in pulmonary hypertension in newborns whose mothers were on Prozac. This follows a September alert from the FDA that use of Paxil during pregnancy may increase the risk of birth defects. These drugs, together with Celexa and Zoloft, belong to a class of antidepressants which act to prolong the effect of the chemical serotonin.

Jan 28, 2006 - A Federal subpoena issued by the U.S. Attorney seeks documents indicating Guidant executives failed to warn that their defibrillators could short-circuit and knowingly sold potentially flawed devices. Guidant first became aware of these failures in early 2002 but waited until May 2005 to notify physicians.   Read More

Dec 30, 2005 - A two year study at VA Connecticut Healthcare found high blood sugar levels in nearly one out of every three patients using atypical antipsychotics such as Seroquel. Patients thought to have normal blood sugar levels, actually demonstrate "significant abnormalities" of glucose metabolism justifying screening.   Read More

August 19, 2005 - A Texas jury found pharmaceutical giant Merck liable for the Vioxx related death of 59 year old Robert Ernst and awarded $253 Million in punitive & compensatory damages. This was the first trial after an avalanche of scientific studies confirmed Vioxx caused an increased risk of heart attacks & strokes, forcing Merck to recall its "blockbuster" COX-2 inhibitor.   Read More

July 4, 2005 - Based upon scientific studies & reports from users, Health Canada, following the FDA lead, expanded the black box warning that Depo-Provera can cause osteoporosis in premenopausal women.   Read More

June 9, 2005- Eli Lilly reported that it reached a settlement of 8,000 cases relating to its schizophrenia drug, Zyprexa. The amount of the settlement was $690 Million or $86,250 per claim. Excluded were those who did not timely register & those represented by attorneys who felt the settlement was inadequate.   Read More

Whistleblower and FDA safety officer David Graham, M.D., created major headlines when he claimed the FDA pressured its own scientists about Vioxx and heart attacks and other cardiac concerns. Vioxx was taken off the market in September 2004, after a study... Read More

Vioxx (valdecoxib) is a COX-2 inhibitor made by Merck & Co. When COX-2 inhibitors entered the market in 1999, the new generation of medications was deemed the "super aspirin" because it claimed to be safer than traditional NSAIDs like aspirin... Read More

Bextra (valdecoxib) is one of three federally approved COX-2 inhibitors that have been used by millions of people worldwide as an arthritis painkiller. Merck & Co. pulled its COX-2 drug Vioxx from the market in September 2004 after an increased risk... Read More

 

FDA Drug Safety Report

In 2004, several high-profile drug safety cases raised concerns about the Food and Drug Administration's (FDA) ability to manage postmarket drug safety issues...Read More