Pfizer announced that it updated the label for its smoking cessation drug, Chantix, to carry a more prominent warning that patients taking the drug should be observed for serious neuropsychiatric symptoms such as behavioural changes, agitation, depressed mood, suicidal ideation and suicidal behaviour.

The update, which is based on an ongoing safety review of post-marketing reports by the FDA and Pfizer, includes information that is similar to what was added to the drug's label in November, but the information is now more prominently located, Pfizer noted.

In addition, the drugmaker said that “a causal relationship between Chantix and these reported symptoms has not been established" but indicated that in some reports "an association could not be excluded.” The company also noted that some post-marketing reports may have been complicated by nicotine withdrawal symptoms, although not all patients with these symptoms had quit smoking.
_______________________________________


January 15, 2008

Study does not show significant difference between Vytorin, Zocor in certain patients

Merck & Co. and Schering-Plough announced Monday that results from the ENHANCE trial, comparing Vytorin with Zocor in patients with heterozygous familial hypercholesterolaemia, showed that there was no statistically significant difference between treatment groups on the primary endpoint. Merck's shares fell as much as 2.1 percent, while Schering-Plough's shares tumbled 6.7 percent on the news.

In the 720-patient randomised trial, participants received either Vytorin, which is a combination of Zetia and Zocor, or Zocor alone. The results showed that there was no significant difference in the mean change in the thickness of the carotid arteries between patient groups. However, the findings also demonstrated a significant difference in LDL cholesterol lowering between the treatment groups at 24 months - 58 percent in the Vytorin group compared with 41 percent in the group that only received Zocor.

A spokesman for Schering-Plough, Lee Davies, stated that the study was "never intended to be a definitive study on outcomes" because it involved a rare population of patients with extremely high LDL cholesterol. As a result, the spokesperson suggested that it may have been difficult to show changes in arterial thickness. Meanwhile, the head of cardiology at the Cleveland Clinic, Steven Nissen, called for a moratorium on the use of Vytorin and Zetia. "In the absence of any evidence of a clinical benefit, these drugs should now be used as a last resort," Nissen stated.

Commenting on the study news, Merrill Lynch analyst David Risinger said that he anticipates "further pressure on Vytorin and Zetia prescription trends." However, Goldman Sachs' James Kelly suggested that the study findings do not "represent a relevant difference for assessing the commercial prospects for Vytorin.“
--------------------------------------------------------------------

January 8, 2008

FDA highlights severe musculoskeletal pain in patients taking bisphosphonates

In a notice posted to the FDA's website on Monday, the agency highlighted the potential of severe and sometimes debilitating bone, joint, and/or muscle pain in patients taking bisphosphonates for the treatment and prevention of osteoporosis.

The FDA noted that while severe pain is already included in the prescribing information for this class of drugs, it may be overlooked by doctors. The agency encouraged physicians to consider temporary or permanent discontinuation of the osteoporosis drugs in patients who develop musculoskeletal pain, and noted that some patients may continue to experience pain even after discontinuing treatment with bisphosphonates.

More information is expected to be provided to doctors after the FDA reviews the risk of joint pain associated with bisphosphonates within the next six months, the agency indicated. Commenting on the news, Merck & Co., which markets Fosamax, said that "the postmarketing reports of musculoskeletal pain [are] not a new development. At this point, a causal association has not been established between bisphosphonates" and severe pain.
---------------------------------------------------------------------

January 4, 2008

Three Drugs Linked to Most Elderly Emergency Room Visits

 There are three common drugs that are linked to adverse reactions that have caused many emergency room visits. The side effects of insulin, warfarin, digoxin have all been linked to about one third of all emergency visits for the aged population. Researchers from the Center for Disease Control and Prevention believe that this to due to the fact that these medications are hard to predict the correct dosage.  Often times these medications have to be tested with individual patients several times before the drug can become fully effective. For example, Warfarin that is used as a blood thinner can actually cause excess bleeding when the blood becomes too thin. Insulin is used to control the blood sugar level in patients. With an incorrect dosage the insulin can actually cause the sugar levels to plummet dangerously low.