Prescribing information for the drugs warns that patients with Alzheimer's-related psychosis "are at increased risk of death compared to placebo".
The agency said the prescribing information for the drugs already contained warnings about pancreatic inflammation, known as pancreatitis.
Merck & Company said yesterday that it would revise prescribing information for its Vioxx painkiller to show both cardiovascular risks and a benefit in reducing side effects like ulcers in arthritis patients.
Because of ACE inhibitors' long-understood hazards in the second or third trimester, the prescribing information for them warns doctors not to prescribe them for pregnant women and to stop them right away if a woman becomes pregnant.
Amgen fell $3.05, or 5.5percentto to $52.10 in regular trading, the most since May 10, when a Food and Drug Administration panel suggested new restrictions in prescribing information for the anemia drug.
The prescribing information for Tamiflu lists cherry syrup made by the Humco Holding Group — a mixture of sugar, purified water, artificial cherry flavoring and some other common ingredients — as one of the approved liquids to mix with the medicine.
Now the Food and Drug Administration has agreed the concerns are valid enough to add new safety alerts to the prescribing information for statins, which are the most widely prescribed drugs in the world.
Federal health officials on Tuesday added new safety alerts to the prescribing information for statins, the cholesterol-reducing medications that are among the most widely prescribed drugs in the world, citing rare risks of memory loss, diabetes and muscle pain.
Dr. Wood noted that after more than a year of contentious negotiations with the F.D.A., the company in 2002 placed on the physician prescribing information for Vioxx a statement that caution should be used in giving Vioxx to patients with heart disease.
The prescribing information for quetiapine recommends appropriate clinical monitoring for alterations in lipids, including blood lipid testing at the beginning of and periodically during treatment (Seroquel Prescribing Information 2012).
The prescribing information for sildenafil suggests ingestion 1 hour before sexual activity and also notes reduced maximum plasma concentration and delayed time to maximum concentration following ingestion with a high‐fat meal.
