May 1, 2010 - FDA Approves a Combination of Generic Naproxen and an Omeprazole Isomer For Arthritis Patients At Risk Of Gastric Ulcers.
Bloomberg News (5/1, Peterson, Larkin), MedPage Today (5/2, Peck), and Reuters (5/1) reported that the FDA has approved Vimovo (naproxen and esomeprazole magnesium) "for use in arthritis patients who are at risk of developing gastric ulcers." Approval was based on endoscopic assessment of gastric erosions compared to treatment with enteric coated naproxen. Naproxen and two other proton pump inhibitor drugs are all available inexpensively without a prescription.
May 3, 2010 - Sample Medications, DTC Advertising May Alter Physician Prescribing Patterns.
Valerie Ulene, MD, writes in the Los Angeles Times (5/3) "The MD" column, "New medications don't have to be unique or innovative to receive approval from the Food and Drug Administration." Most new medicines "provide only minor, if any, therapeutic benefit over existing medications, the agency acknowledges." Pharmaceutical companies use medication sampling and direct-to-consumer advertising to stimulate use of new medications “even when there is no evidence suggesting that a new medication works better than something tried and true.
May 3, 2010 Triple Combination Antihypertensive Pill Better At Lowering Blood Pressure Than Dual Therapies Using Its Components.
MedPage Today (5/3, Neale) reported that a combination of three currently available blood pressure medications resulted in lower blood pressure and greater percentages of patients achieving blood pressure goals than any combination of only two of the agents according to a study presented at American Society of Hypertension meeting. The combination contains high doses of two generically available medications and an Angiotensin Receptor Blocker (ARB) high blood pressure medication. The Angiotensin Receptor Blocker is currently available in a fixed combination with the diuretic. Extensive data support the long term benefit of the diuretic in reducing risk of death due to cardiovascular events. The ARB has some indication of possible benefits, though not as strong as other medications, and the calcium channel blocker medication is not associated with any long-term benefits relating to CV disease progression or survival.
May 3, 2010 – FDA Warns Certain Prostate Cancer/ Endometriosis Treatments May Increase Risk Of Diabetes, Heart Attack.
The Dow Jones Newswire (5/3, Dooren), HealthDay (5/3, Preidt), and the Los Angeles Times (5/3, Maugh) "Booster Shots" blog reported, The Food and Drug Administration is examining possible links between gonadotropin-releasing hormone (GnRH) agonists and increased risks of diabetes and heart disease. The drugs are also used by women to manage endometriosis pain, anemia associated with uterine fibroids, and as palliative treatment of advanced breast cancer. They may also be used to treat some children for precocious puberty. However, there is not evidence for increased risks in women or children. MedPage Today (5/3, Petrochko) and Bloomberg News (5/4, Larkin) also covered the story.
