Stent procedures have been linked to high readmission rates with about one out of every six patients readmitted to the hospital within one month of their original procedure.

Stents are tiny wire-mesh tubes used during heart surgery that prop arteries open after angioplasty, in which blockages are cleared. Some stents are manufactured with a drug coating meant to keep blood vessels from re-clogging. (more…)

A new hip and knee implant study is raising questions about newer model devices that might not perform any better than older generation designs that cost less. As a matter-of-fact, the older, cheaper models might actually last longer. A big consideration given that when a hip or knee implant fails or needs replacing, surgery is required.

The New York Times said that the newly published study reviewed information from Australia’s orthopedic registry and looked at implants that were introduced to the market 2003 – 2007. Metal-on-metal implants are constructed with both a metal ball and metal cup, said The Times, and were intended to be longer lasting than their predecessors. Unfortunately, the newer generation implants are expected to fail earlier, with replacements needed much sooner than the older implants, which generally last for about 15 years, The Times pointed out. (more…)

Following a year of recalls, Johnson & Johnson has implemented yet another. This time, Johnson & Johnson is recalling a massive 12 million bottles of Motrin. It seems the defective Motrin dissolves too slowly.

Johnson & Johnson’s McNeil Consumer Healthcare unit wrote in a statement on its website that product testing indicated that some Motrin caplets might not dissolve as soon as they are supposed to when the mediation nears its expiration date, said Bloomberg Businessweek. Customers do not have to return the painkillers; however, there may be what McNeil described as “a delay in relief” after taking Motrin, spokeswoman Bonnie Jacobs told Businessweek. (more…)

Lawsuits are mounting over Proscar and Propecia, and claims have been filed federally and at the state level. Plaintiffs allege that the drugs are dangerous and that drug maker Merck, knew or should have been aware, but neglected to warn, of side effects that include erectile dysfunction, infertility, depression, and suicide.

Proscar and Propecia, which are known generically as finasteride belong to a class of drugs called 5-alpha reductase inhibitors, or 5-ARIs. Proscar is used to treat enlarged prostate, while Propecia is used to treat male pattern baldness. (more…)

Heart drug, Multaq, is subject to new restrictions, according to federal health officials. New safety warnings are being mandated following a study by drug maker, Sanofi, that linked Multaq (dronedarone) to serious cardiac events as well as a review of clinical trial data by the U.S. Food & Drug Administration (FDA) that revealed a link between Multaq and increased heart attack, stroke, and death in some patients.

Multaq is approved to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted.

The new boxed warning stresses study results that revealed that Multaq doubled risks for cardiac complications in patients with permanent AF, said The Associated Press (AP). Permanent AF is a condition in which the heart’s chambers pump out of rhythm. The new label also emphasizes that Multaq is only approved for short-term AF and AFL, a related condition, said the AP.

The FDA announced that it completed a safety review of Multaq that revealed an increased risk of serious cardiovascular events, including death, when used by patients in permanent AF; the FDA’s review was based on data from the PALLAS and ATHENA clinical trials. The revised Sanofi label, which was written collaboratively by the FDA and Sanofi and has been revised with the following changes and recommendations:

• Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
• Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
• Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF).
• Patients prescribed Multaq should receive appropriate antithrombotic therapy.

The FDA initiated its Multaq safety review in January, updating the drug’s label to include “liver injury, including acute liver failure requiring transplant, has been reported in patients treated with Multaq.” In July, the FDA expanding this warning to include heart side effects, following PALLAS study results that revealed that patients taking Multaq for permanent AF were at a two-fold risk of death and increased risks for heart attack and stroke.. PALLAS was ceased over the summer after Multaq patients experienced higher-than-anticipated adverse cardiac events.

Yesterday’s FDA Drug Safety Communication indicated that 25 Multaq patients died during PALLAS, as opposed to 13 in the placebo group. Of those, 14 Multaq patients experienced sudden death or death from arrhythmia, versus 4 in the placebo group. In the Multaq group, 23 patients suffered stroke and 43 were hospitalized with heart failure, versus 10 and 24, respectively, from the placebo group. The FDA also reviewed ATHENA data, which was used to grant Multaq’s approval for temporary AF. The Safety Communication indicated that Multaq patients did not suffer increased cardiovascular death, stroke, or heart failure risks and, because of this, the FDA maintains that Multaq provides a benefit for patients with non-permanent AF.

In the midst of probes, shareholder lawsuits, and broad criticism concerning its Infuse bone growth product, Medtronic is making headlines again. This time, three senators are asking for information on Medtronic’s Infuse product.

Senators Charles Grassley (Republican-Iowa), Herb Kohl (Democrat-Wisconsin), and Richard Blumenthal (Democrat-Connecticut) asked, in a letter described by The Star Tribune as having an “investigational tone,” for very specific information on how Medtronic monitors its products once they are released and for information on Infuse. (more…)

A Class I recall, the U.S. Food & Drug Administration’s (FDA) most serious designation, has been issued for St. Jude Medical Inc.’s Riata leads. The recall involves the performance of Riata® and Riata® ST Silicone Defibrillation Leads. The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction.

Last year, St. Jude sent a letter to physicians explaining that the devices’ cables with newer coating experienced less problems and have almost replaced older versions (the phase-out is expected to be completed by year end); At the time the letter was sent, an FDA spokeswoman said that the issue did not warrant a recall. (more…)

The SSRI link to PPHN remains unclear, according to the U.S. Food & Drug Administration (FDA), which just issued an update to the public concerning the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by expectant mothers. At issue is the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN).

The FDA’s initial Public Health Advisory issued in July 2006 on this potential risk was based on one published study; however, since, there have been conflicting findings from new studies evaluating the risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN. At this time, the agency is advising health care professionals not to alter their current clinical practice of treating depression during pregnancy. Healthcare professionals and patients should report any adverse events involving SSRIs to the FDA MedWatch Program, the agency said. (more…)

As Congress mulls deregulating toxic coal ash, 20 toxic coal ash dumps have been uncovered in 10 states.

The dumps, discovered by the nonprofit Environmental Integrity Project (EIP), have contaminated groundwater and soil. At the same time, some members of Congress are seeking more leniency on federal oversight of toxic coal ash pollution cleanup and are asking that authority be eliminated that currently ensures compliance with significant standards. The 20 new sites identified in the report are: (more…)

A Medtronic Infuse shareholder lawsuit was just granted class action status by a Minnesota federal judge. The shareholder group alleges that Medtronic Inc.’s stock value dropped over Medtronic’s off-label promoting of its Infuse spinal graft product.

Cleared by the U.S. Food & Drug Administration (FDA), in 2002, Medtronic Infuse is a bone growth product approved for use in one type of spine surgery (anterior approach lumbar fusion), Infuse was ultimately approved for two different types of dental surgery. (more…)