Merck may face additional 100 lawsuits over Fosamax
WHITEHOUSE STATION, N.J. Merck is facing as many as 100 new lawsuits in which the company is being accused of failing to warn that its osteoporosis drug Fosamax may cause irreversible jaw-rot, according to Bloomberg.
The company is already facing more than 400 lawsuits in U.S. federal and state courts regarding the drug. As of March 31, Merck faced about 465 Fosamax cases, including suits with multiple patients, the company said last month.
Patients who used Fosamax claim Merck misrepresented its safety, failing to warn doctors and patients that it may hamper blood flow to the jaw, causing jawbone-tissue death. The company last week said it reserved $60 million for future Fosamax litigation costs, up from $48 million.
Fosamax had sales of $3 billion in 2007, although sales are expected to drop by over half this year due to generic competition.
Amgen, Wyeth revise labeling for Enbrel
PHILADELPHIA and THOUSAND OAKS, Calif. Amgen and Wyeth Pharmaceuticals have informed health care professionals of revisions to prescribing information for their rheumatoid arthritis and psoriasis medication Enbrel.
The revisions include a boxed warning about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel.
Infections have included bacterial sepsis and tuberculosis. The adverse reactions section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel.
FDA approves Advair for wider use with COPD patients
WASHINGTON The Food and Drug Administration has approved GlaxoSmithKline’s asthma drug Advair to be used more widely to treat patients with chronic obstructive pulmonary disease, according to published reports. The drug had been approved to prevent wheezing and control other symptoms in COPD patients.
GSK’s approval comes the same day as rival AstraZeneca said it also was seeking FDA approval to sell its drug Symbicort for COPD.
COPD, an often-fatal lung condition with no cure, is a major market with more than 12 million Americans suffering from the disease, and another 12 million who are likely not diagnosed, according to the National Institutes of Health.
The FDA’s approval allows GSK to promote its product to COPD patients who experience flare-ups of the disease, which includes emphysema and chronic bronchitis.