Product News and Recalls

Merck delays approval for new drug

According to a story in the New York Times, Merck is delaying its attempts to get approval for an experimental osteoporosis drug called odanacatib, because it is seeking additional data from a clinical trial. That announcement helped send the company’s shares down 3 percent.

The story says Merck reported that it earned $1.4 billion, or 46 cents a share, in the fourth quarter. That compares with $1.51 billion, or 49 cents a share, from a year earlier. And earnings were 83 cents a share in the fourth quarter, down from 97 cents a share the previous year. Sales for the quarter fell 5 percent, to $11.74 billion.

The company continues to rely heavily on strong sales of drugs like the diabetes medicine Januvia. But some recent studies indicate that Januvia may be problematic as well.

Januvia has been linked to pancreatitis and pancreatic cancer. Another diabetes drug, Byetta, has also been linked to those conditions, as well as an increased risk of thyroid cancer.

The story says that Merck suffered another setback in December when a cholesterol medication called Tredaptive failed to protect against heart attacks and strokes in a large clinical trial. Merck subsequently announced it would not seek approval of Tredaptive in the United States and withdrew it from the European market.

The story describes odanacatib as a once-weekly pill to treat osteoporosis in postmenopausal women. A clinical trial last July appeared to show benefits to patients, but the company continued a follow-up trial of 8,000 women to keep monitoring potential safety issues.

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a Lopez McHugh attorney if you or a loved one was diagnosed with pancreatic cancer after taking Januvia or Byetta.

See the story here:

http://www.nytimes.com/2013/02/02/business/merck-delays-osteoporosis-drug.html