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FDA Says Mirapex May Pose Risk of Heart Failure

The U.S. Food & Drug Administration (FDA) just announced that Parkinson’s disease medication, Mirapex (pramipexole), may pose increased risks for heart failure. The agency notified health care professionals following release of recent study results.

A Parkinson’s disease drug, Mirapex is also approved to treat the symptoms of moderate to severe primary restless legs syndrome. Mirapex is in the class of drugs called dopamine agonists and works by acting in place of dopamine. Dopamine is produced by specific areas of the brain that control movement; Parkinson’s disease causes progressive loss of dopamine production in the brain. (more…)

Judge Promises To Expedite Pradaxa Bleeding Lawsuits

The judge involved in the multidistrict litigation (MDL) over controversial blood thinner, Pradaxa, has promised to expedite Pradaxa bleeding lawsuits. Pradaxa has allegedly been associated with life-threatening, uncontrolled bleeding.

The MDL now includes 78 cases, said The Madison Record. As NewsInferno recently explained, lawsuits alleging that Boehringer Ingelheim Pharmaceuticals, the maker of Pradaxa, neglected to sufficiently warn users of the blood thinner’s links to deadly bleeding ,were consolidated in an MDL in U.S. District Court, Southern District of Illinois. This means that every Pradaxa bleeding lawsuit filed in federal district courts will now, and in the future, be transferred to the Southern District of Illinois. The cases will be presided over by U.S. District Judge David R. Herndon. The case is entitled IN RE: Pradaxa (Dabigatran Etexilate) Products Liability Litigation. (more…)

Drug Safety Experts Say FDA Allowing Dangerous Drugs on the Market

Drug safety experts report that the U.S. Food & Drug Administration (FDA) is allowing dangerous drugs to find their way to market. The article was published, today, in the Journal of the American Medical Association.

The article blames the agency’s work to speed approval of new drugs to be what has allowed stroke prevention, cancer, and multiple sclerosis medications to be released without proper safety reviews, said The Wall Street Journal. The article, written by drug safety experts Thomas J. Moore and Curt D. Furberg, states that, in the agency’s zeal to approve medications, they might have mitigated prescription-drug safety. The pair pointed to a multiple sclerosis (MS) drug that has some significant cardiac side effects as well as numerous other risks, as well as Pradaxa, an anticoagulant linked to dangerous bleeding that can be “difficult to treat,” said The Journal. (more…)

Study Casts Doubt on Plavix-Aspirin Combo for Stroke Prevention

A new study found that the Plavix-aspirin combination for stroke prevention might not be as effective or safe as initially believed. The research revealed that the combination was no better than aspirin alone in second stroke prevention for people whose first stroke was—for the most part—the result of high blood pressure, said HealthDay News. The Canadian researchers noted that the Plavix-aspirin combination also increased risks for gastrointestinal bleeding and death. (more…)

Consumer Reports Slams Generic Actos

Consumer Reports has slammed the generic versions of the Type 2 diabetes medication Actos (pioglitazone), recently approved by the U.S. Food & Drug Administration (FDA).

Not only does Consumer Reports suggest skipping the two generics, but it also urges consumers against using the Actos brand unless other options have failed, it said. In fact, said the long-time product comparison expert, Actos/pioglitazone can lead to serious adverse events including heart attack, bone fractures, and bladder cancer. Other diabetes drugs are considered better first options. (more…)

FDA: Giving Children Codeine Post-Surgery Raises Death Risk for Some

The U.S. Food & Drug Administration (FDA) has announced that treating children with codeine after surgery might increase their risk of death. To date three children—ages two to five—have died and one child suffered a nonfatal, but serious and life-threatening case of respiratory depression after codeine treatment following surgery to remove tonsils and/or adenoids.

The surgeries were performed to treat obstructive sleep apnea syndrome, a condition that results in repeated episodes of complete or partial blockage of the upper airway during sleep, the FDA explained. The children received codeine within the typical dose range. (more…)

Study Confirms Actos, Other Thiazolidinediones Increase Bladder Cancer Risk

A new study confirms that Actos and other thiazolidinediones drugs do, in fact, increase the risk for developing bladder cancer. The study appears online this month in the Journal of the National Cancer Institute.

Researchers from the Perelman School of Medicine at the University of Pennsylvania discovered that patients taking Actos and other thiazolidinedione (TZDs) drugs suffer a two-to-three-fold increased likelihood of developing bladder cancer when compared to people who took a sulfonylurea drug, said Science Daily. TZDs comprise some 20 percent of medications prescribed to diabetics in the United States; sulfonylurias are another popular diabetes drug class that include Glucotrol (glipizide). (more…)

Bayer Reports More Yaz, Yasmin Lawsuit Settlements

Bayer, maker of Yaz and Yasmin birth control pills, reports more lawsuit settlements connected to the oral contraceptives.

According to Bayer AG, settlements over Yaz and Yasmin have topped $402 million and involve claims that the contraceptives caused blood clots in women, said Bloomberg Businessweek. To date, Leverkusen, Germany-based Bayer, has resolved nearly 1,900 cases that involve allegations that Yasmin and Yaz caused dangerous blood clots that can lead to heart attacks and strokes, according to its most recent stockholders’ newsletter. (more…)

Avoid Benzocaine for a Teething Baby, FDA Warns

Avoid benzocaine for teething babies, the U.S. Food & Drug Administration (FDA) warns. According to the agency, benzocaine products should only be used to relieve teething pain in babies under the advice and supervision of a physician.

A local anesthetic, benzocaine is a fairly ubiquitous ingredient found in a number of over-the-counter (OTC) products including, Anbesol, Orajel, Baby Orajel, Orabase, and Hurricane noted Medical Xpress. (more…)

Seizure Warning Issued for MS Drug

The U.S. Food & Drug Administration (FDA) just issued a seizure warning for multiple sclerosis (MS) drug, Ampyra (dalfampridine). Ampyra has been linked to increased seizure risks in MS patients.

Developed by Acorda Therapeutics, Ampyra is marketed by Biogen Idec Inc in Europe under the brand Fampyra, explained Reuters. The drug was created to improve walking ability in MS patients. Based on post-market adverse event reports it reviewed, said the agency, the seizure risk in MS patients—none of whom had a history of seizure—was evidenced within days and weeks after beginning treatment with the recommended dose, noted Reuters. (more…)

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