Drug Recall Watch

Parents file Zoloft birth defects lawsuit after daughter’s death

Drug Recall Watch — Fri, 27 Jan 2012 22:57:22 +0000

A Missouri family has filed a Zoloft lawsuit after their infant daughter was born with birth defects. The lawsuit alleges that the antidepressant’s manufacturer knew about the increased risk of birth defects in women who take Zoloft during pregnancy, but failed to properly warn patients.

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To prescribe or not to prescribe: That is the statin question, experts debate

Drug Recall Watch — Fri, 27 Jan 2012 22:55:10 +0000

Are statins one of the greatest advances since the introduction of antibiotics, capable of preventing cardiovascular disease in a wide range of patients, even healthy ones, or are clinicians relying too heavily on the lipid-lowering medications, using the drugs too frequently in individuals who would be better treated with an overhaul of their diet and exercise habits?

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FDA Turns Down Expanded Use of Merck’s Vytorin and Zetia

Drug Recall Watch — Wed, 25 Jan 2012 16:50:47 +0000

Merck & Co., the second-biggest U.S. drugmaker, said cholesterol treatments Vytorin and Zetia failed to win approval to prevent heart attacks and strokes in patients with chronic kidney disease. Vytorin is a combination of Zetia and Zocor, or simvastatin, and has been available in generic form since 2006.

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FDA dings Hospira for ‘misleading’ ads for blood drug

Drug Recall Watch — Wed, 25 Jan 2012 16:48:06 +0000

The U.S. Food and Drug Administration has admonished Hospira Inc. for overstating the capabilities of Voluven, a plasma substitute designed to increase patients’ blood volume after surgery or trauma. In an apparent bid to boost sales, Hospira has improperly claimed that Voluven can be used during major abdominal surgery, to prime cardiac pumps and to treat swelling, according to an FDA letter to a Hospira executive.

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FDA Warns J&J’s DePuy Orthopaedics Unit On Custom Devices

Drug Recall Watch — Thu, 19 Jan 2012 19:18:57 +0000

Federal regulators warned Johnson & Johnson’s (JNJ) DePuy Orthopaedics unit that several of its hip, knee and joint replacements were improperly marketed, prompting the company to stop offering some products. In a letter dated Dec. 8, the U.S. Food and Drug Administration said some of the medical-device maker’s products lacked valid applications for premarket approval or investigational device exemptions.

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SSRIs Boost Risk of Falls in Dementia Patients

Drug Recall Watch — Thu, 19 Jan 2012 18:37:07 +0000

Nursing home residents with dementia who use selective serotonin reuptake inhibitors (SSRIs) have an increased risk of having a fall that causes injury compared with those who do not use SSRIs, new research shows. ”Even at low doses, SSRIs are associated with increased risk of an injurious fall in nursing home residents with dementia,” the authors write.

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FDA says Johnson & Johnson subsidiary DePuy sold orthopaedic devices without approval

Drug Recall Watch — Wed, 18 Jan 2012 23:12:50 +0000

A Johnson & Johnson subsidiary sold more than a dozen types of components for orthopaedic devices without getting the necessary approval from regulators, the U.S. Food and Drug Administration said in a warning letter released this week. DePuy Orthopaedics Inc., based in Warsaw, Ind., also had a quality system that didn’t comply with all of the FDA’s requirements, according to the warning letter.

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Propecia study finds sexual side effects can be long-lasting

Drug Recall Watch — Tue, 17 Jan 2012 21:46:32 +0000

A study has found that men who use the hair loss drug Propecia may face an increased risk of long-lasting sexual side effects. The Journal of Sexual Medicine study found that a significant majority of patients in their study suffered sexual problems for months—and sometimes years—after they stopped taking Propecia for hair loss.

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Daily Aspirin Is Not for Everyone, Study Suggests

Drug Recall Watch — Tue, 17 Jan 2012 21:44:28 +0000

Nearly a third of middle-aged Americans regularly take a baby aspirin in the hope of preventing a heart attack or a stroke or lowering their cancer risk. But new research shows that aspirin is not for everyone, and that in some patients this so-called wonder drug is doing more harm than good.

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Statins raise risk of Type 2 diabetes in older women, study finds

Drug Recall Watch — Wed, 11 Jan 2012 17:38:35 +0000

Older women who take statin medications like Zocor, Lipitor, Pravachol and Crestor to ward off heart attacks are more likely to develop Type 2 diabetes than those who do not take the widely used cholesterol-lowering drugs, a study has found. The report, published Monday in the Archives of Internal Medicine, showed that, in a large group of post-menopausal women, those who took a statin of any type were, on average, 48% likelier to develop Type 2 diabetes than those who didn’t.

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