Obesity drug withdrawn following trial showing heart attack, stroke risk
SILVER SPRING, Md. Clinical trial data indicating an increased risk of heart attack and stroke has led to the removal from the market of an obesity drug made by Abbott, the Food and Drug Administration said Friday.
The FDA said the drug maker voluntarily withdrew the drug Meridia (sibutramine) following a required post-marketing trial showing that the drug increased by 16% the risk of nonfatal heart attacks and strokes, the need for resuscitation after the heart stopped and death.
“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achive on this drug to their risk of heart attack or stroke,” FDA office of new drugs director John Jenkins said. “Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their healthcare provider about alternative weight loss and weight-loss maintenance programs.”
The FDA approved Meridia in 1997 for weight loss and maintenance of weight loss in obese people and some overweight people with other risks for heart disease, based on clinical trial data showing that people taking the drug lost at least 5% of their body weight compared with those taking placebo who relied on diet and exercise alone.
IMS Health projects growth for Rx market
NORWALK, Conn. The global pharmaceutical market will reach a value of $880 billion next year, according to a report by market research firm IMS Health.
IMS Health forecasted 5% to 7% growth in 2011 in its annual IMS Market Prognosis, compared with 4% to 5% growth this year.
Generic drugs will become dominant in many therapies, as drugs with sales of more than $30 billion are expected to lose patent protection next year. These include Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin calcium), Bristol-Myers Squibb’s and Sanofi-Aventis’ cardiovascular drug Plavix (clopidogrel bisulfate), Eli Lilly’s antipsychotic Zyprexa (olanzapine) and Johnson & Johnson’s antibiotic Levaquin (levofloxacin).
At the same time, much innovation is expected to occur in the area of specialty drugs –– drugs to treat such complex and often unmet therapeutic needs as multiple sclerosis, cancer and hepatitis C –– and patient access is expected to increase. IMS predicted five potential blockbuster drugs, meaning those with annual sales of $1 billion or more, will be approved over the course of the year.
Public and private payers are expected to reduce their growth in drug budgets, according to the report. In the United States, this is in the form of health plans increasing use of cost-sharing provisions and pre-authorizations.
“In 2011, we will see the loss of exclusivity for some iconic brands and a promising new wave of innovation,” IMS SVP Murray Aitken said. “It will also be a critical year for gauging how healthcare-reform initiatives in key markets evolve and play out amid the expected macroeconomic recovery. For pharmaceutical manufacturers, an unrelenting focus on bringing distinct value to patients and health systems will be essential to navigating this dynamic market.”
Overall, the company expected divergent growth in different markets. The United States will remain the largest drug market, growing 3% to 5% to $310 billion. Japan will grow by 5% to 7%, while Canada and the five major European markets of the United Kingdom, Germany, Spain, Italy and France will grow by 1% to 3%. The so-called “pharmerging markets” will experience the most dramatic growth, 15% to 17%, including 25% to 27% growth in China, which will remain the world’s third-largest pharmaceutical market at $50 billion.
Walgreens collaborates with two groups to drive flu prevention, boost awareness
DEERFIELD, Ill. Underscoring its determination to be the nation’s premier source of flu immunization services, Walgreens on Thursday revealed it is working with the National Foundation for Infectious Diseases to educate the public and health professionals about flu prevention resources. In addition, Walgreens has joined with Families Fighting Flu, a nonprofit organization of families and healthcare practitioners, to heighten flu awareness and encourage vaccinations for children and families.
In a flu season kickoff, NFID held its annual news conference in Washington, D.C., on Thursday. Health experts at the event discussed immunizations as the best protection against flu viruses and offered new information from the medical community. They also highlighted the complementary role that Walgreens and other pharmacies now play for immunization services within the U.S. healthcare system.
“Working with NFID and Families Fighting Flu –– and through ongoing efforts with the medical community and government agencies –– we’ll continue to arm the public with the information they need to protect themselves,” said Kermit Crawford, Walgreens president of pharmacy services. “With new [Centers for Disease Control and Prevention] recommendations, an all-in-one vaccine and unprecedented access to flu shots, our goal is to achieve higher immunization rates that can lead to a lower incidence of flu in the United States this season.”
Walgreens pharmacists, along with clinicians at its in-store Take Care Clinics, provided some 7 million vaccinations during the 2009-2010 flu season. This year, the company has set a much higher goal: to immunize 15 million Americans nationwide.