Flu Vaccine Manufacturers Expect Delays in Availability
Flu Vaccine Manufacturers Expect Delays in Availability
By William T. Elliott, MD, FACP
The manufacturers of this year’s flu vaccine have told the fda and CDC to expect delays in vaccine availability and perhaps even reductions in the amount of vaccines available this fall. Many mass vaccination programs are already announcing that they will be delaying their start until November, a month later than their usual start. The FDA, CDC, and vaccine manufacturers are confident that vaccines will be available for those at highest risk of complications from influenza, including those older than 65 years of age, those who are immunosuppressed, and others. The shortage is due to a lower than expected yield for one viral component of the vaccine. The shortage may prove to be a windfall for the manufacturers of the antivirals zanamivir and oseltamivir.
The FDA has approved fluoxetine (Sarafem) for the treatment of premenstrual dysphoric disorder (PMDD). The drug, which is a selective serotonin reuptake inhibitor, has been available for more than ten years for depression under the trade name Prozac. It was shown in clinical studies presented to the FDA to significantly improve mood changes associated with PMDD. Eli Lilly felt that women may be reluctant to take a drug known as an antidepressant for this indication, hence the name change. The company will package fluoxetine as Sarafem in a seven-day blister pack, to be taken just prior to menses. PMDD is a form of premenstrual mood dysphoria characterized by severe mood and physical symptoms.
The FDA has approved balsalazide disodium for the treatment of mild to moderate ulcerative colitis. The drug, which is a prodrug of 5-ASA, will be marketed under the name Colazal by Salix Pharmaceuticals. Balsalazide is a minimally absorbed oral preparation that is approved for a course of therapy of up to 12 weeks. During the course of clinical investigations, the most commonly reported side effects were headache and abdominal pain.
Merck and Schering-Plough are collaborating to market two combination drugs. The first will combine simvastatin (Zocor) and Schering-Plough’s investigational cholesterol absorption blocker, ezetimibe, in a once-a-day tablet for the treatment of hypercholesterolemia. The other combination will couple Merck’s montelukast (Singulair) with Schering-Plough’s loratadine (Claritin) for the treatment of asthma and allergic rhinitis.
A battle is brewing between congress and the pharmaceutical industry over the issue of re-importation of U.S.-made prescription drugs back into the country. The legislation is aimed at the practice of charging higher prices for prescription drugs in the United States, compared to the prices charged for the same drug at pharmacies just across the border in Canada or Mexico. The legislation would allow Americans to purchase their medication in another country and bring it back for use in this country. The industry is mounting a massive campaign to defeat the proposal, suggesting that drugs purchased outside the United States are likely to be adulterated, mislabeled, or improperly shipped or stored.
More evidence suggests that COX-2 inhibitors affect renal function in the elderly to similar extent as standard NSAIDs. Compared with placebo, single doses of rofecoxib and indomethacin decreased the glomerular filtration rate by 0.23 mL/s and 0.18 mL/s, respectively. The drugs were also given in multiple doses for five days. Respective decreases of 0.14, 0.13, and 0.10 mL/s were observed after multiple doses of rofecoxib, 12.5 mg/d, rofecoxib, 25 mg, and indomethacin were administered. Changes in creatinine clearance and serum and urinary sodium and potassium were less pronounced. Swan and colleagues conclude that the effects of COX-2 inhibition on renal function are similar to those observed with nonselective NSAIDs. Thus, COX-2 seems to play an important role in human renal function (Ann Intern Med 2000;133:1-9).
Novartis has added a black box warning to it’s antipsychotic drug thioridazine (Mellaril) because of concerns over prolonged QTc intervals. The FDA asked Novartis to add the warning because of the risk of life-threatening ventricular arrhythmias including torsade de pointes. The drug, which has been available for more than 40 years, will continue to be produced, but in a Dear Doctor letter, the company advises that "switching to a different antipsychotic agent should be considered."
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