Baxter heparin linked to allergic reactions
Baxter Healthcare Corp. temporarily stopped manufacturing multiple-dose vials of heparin due to a spike in reports of serious allergic reactions and hypotension in patients receiving bolus doses of the drug. Serious reactions to Baxter heparin have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people died after receiving heparin, FDA said, although the relationship to the drug is unclear.
Attention quickly turned to a Chinese plant that manufactures the active ingredient in heparin for Baxter. FDA records indicated the firm had been misidentified and had not been inspected before Baxter's application for heparin was approved.
FDA said some 350 adverse events associated with Baxter heparin have been reported since the end of 2007, compared to less than 100 reports in all of 2007. Most of the reports came from hemodialysis centers, almost exclusively involving patients receiving a bolus dose. While most of the reports involved multiple-dose vials, FDA said, several cases included patients who received a bolus dose after their health care professional combined heparin from single-dose vials.
Injunction against EC requirement continues
A Washington State federal judge has refused to lift an injunction that prevents a state policy from going into effect to require pharmacies in the state to dispense emergency contraception.
The injunction was issued in a July 2007 suit brought by a pharmacy owner and two pharmacists claiming that the state Board of Pharmacy rule establishing a duty to dispense emergency contraception violated their civil rights. Federal judge Ronald Leighton issued the November 2007 injunction that allows pharmacists who oppose emergency contraception to refer customers to other pharmacies. Under the court-established "refuse-and-refer" policy, as long as pharmacists immediately refer customers to nearby pharmacies, the state can't punish the pharmacy for declining to provide emergency contraception.
The state Department of Health and Board of Pharmacy asked Leighton to lift the injunction until the 9th U.S. Circuit Court of Appeals rules on the case. The agencies said state residents have a legal right to obtain emergency contraception from pharmacies and that the injunction "broadly infringes on that right, placing the public at greater risk of denial of access to care." However, Leighton said he believes the arguments from each side are not based on an effort to establish sound health policy, but rather stem from bitterness between the two sides. "I do not get the impression that this is a solvable problem," he said, "and it's not an issue that anyone wants to have solved." He said the case ultimately could get to the U.S. Supreme Court.
New antibiotics don't help VRE patients
Researchers say the discovery of potent new antibiotics has not led to significant improvement in patients with vancomycin-resistant Enterrococcus (VRE) bacteremia. "This suggests that vancomycin resistance does not significantly influence mortality," said Kristine Mace Erlandson, MD, and colleagues in a report in the January 1 Clinical Infectious Diseases.
The researchers looked at 113 patients with VRE bacteremia treated at the University of Nebraska Medical Center from August 1993 to September 2005. Some 71 patients were initially treated with linezolid, 20 with quinupristin-dalfopristin, and 22 with combinations of other agents. Overall, 42 of the 113 patients (37.2%) died and in 29 of the deaths (69%), VRE bacteremia was the cause or a significant contributor to mortality.
The analysis showed significantly fewer deaths in the linezolid group compared with the other agents. However, Erlandson says that after adjustment for severity of illness, treatment group was not a significant independent factor in mortality
ASHP urges BTC consideration for statins
The American Society of Health-system Pharmacists (ASHP) says existing models of over-the-counter (OTC) dispensing are not sufficient to ensure safe and effective use of cholesterol-lowering statins, and recommends instead that FDA consider placing them behind-the-counter (BTC). ASHP released its position in a letter to FDA for a joint meeting of the agency's Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee that was considering a request from Merck for OTC status for its Mevacor® (lovastatin). "ASHP does not support reclassification to OTC status as that status is currently constructed, although the society does believe that alternative nonprescription models for dispensing these valuable medications should be explored," the letter said. The society said it would support implementation of a BTC system that would require an initial laboratory assessment of LDL-C levels and ongoing monitoring of response to statin therapy to alleviate concerns that patients in the highest risk groups for cardiovascular disease might receive BTC therapy at suboptimal dosing.
"Pharmacist consultation would prevent inappropriate use of statins and result in increased physician referrals for those patients who need more complex care," ASHP said.
The society noted that once statin therapy starts, ongoing evaluations are needed to assess the patient's response, reassess risk factors, and monitor for and report adverse drug events. "The existing model for OTC medications would place the entire burden for performing these functions on the patient," ASHP said."
Baxter Healthcare Corp. temporarily stopped manufacturing multiple-dose vials of heparin due to a spike in reports of serious allergic reactions and hypotension in patients receiving bolus doses of the drug.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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