Asthma medication under fire by the FDA amid study findings
ROCKVILLE, Md. A biotech drug used to treat asthma in teenagers and adults has attracted the scrutiny of the Food and Drug Administration amid study findings that it could increase the risk of heart disease.
The study suggests that Xolair (omalizumab), developed by Genentech and Novartis, could increase the risk of ischemic heart disease, arrhythmias, cardiac failure, pulmonary hypertension and other heart disease. The drug is used in patients for whom inhaled asthma drugs are inadequate.
The FDA said it was not recommending changes to Xolair’s prescribing information or advising patients not to use the drug. It also said that until it finishes evaluating the study, titled “Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma,” healthcare providers and patients should be aware of the risks and benefits described in Xolair’s prescribing information, as well as the information from the study.
As of Friday, Novartis and Genentech had not made a public statement regarding the study.
H.D. Smith elevates sales, purchasing leaders
SPRINGFIELD, Ill. Pharmacy wholesaler H.D. Smith has promoted two veteran executives in a continuing bid to strengthen its senior management ranks and boost its growth potential.
The latest moves include the promotion of Jeff Greer to VP sales and Bob Dynek Jr. to VP purchasing and trade relations.Greer, who joined the company in 2005 after long service with drug wholesale giant AmerisourceBergen, will lead an effort by H.D. Smith to expand into new service sectors. Dynek, an 11-year company veteran whose previous career included stints with General Drug Co., Foxmeyer Corp. and Louis Zahn Drug Co., will will have primary responsibility for purchasing and managing inventory service levels across all business segments.
“Moving Jeff and Bob into corporate headquarters will take full advantage of growth potential for the company,” said Dale Smith, chairman and CEO. “Together, they bring more than 50 years of expertise in pharmacy distribution and will be influential in helping us realize our goal of becoming the preferred pharmaceutical wholesaler nationwide.”
Diabetes not sole cause of depression in diabetic patients, study suggests
NEW YORK Increased risk of depression in diabetic patients could be the result of more frequent contacts with the medical system, rather than the disease itself, a new study suggested.
Previous research suggested that diabetic individuals faced a higher risk of depression, yet few studies accounted for the number of primary care visits that patients make, noted Patrick O’Connor of HealthPartners Research Foundation in Bloomington, Minn., and his colleagues.
To investigate, O’Connor and his colleagues analyzed records from a large medical group that treated about 225,000 patients between 1997 and 2003 and found that the likelihood of being newly diagnosed with depression fell as the number of times the patient visited the doctor increased.
Among the group of diabetic patients with few physician visits during the study period were 46% more likely to be newly diagnosed with depression during the course of the study. But for the diabetic patients who had more than 10 physician visits during the study period, the risk of a new depression diagnosis was similar to that of non-diabetic individuals who visited their physicians equally often.
The reason why people — diabetic or not — who visit the doctor less often are more likely to be depressed isn’t clear, the researchers said. “These data might indicate that primary care clinicians are good at recognizing depression after only a few visits,” they wrote. “Other explanations are possible, however; perhaps physician who do not recognize depression early are not likely to diagnose it later.”
This study was published in Annals of Family Medicine, July/August 2009.