Austin woman, injured by surgical mesh, lobbies to strengthen medical device law

Lana Keeton said she almost died in December 2001 after a surgery to implant a synthetic mesh bladder sling for occasional incontinence. Now, she’s an advocate for patients who lobbies federal officials to strengthen oversight of medical devices such as surgical mesh. In July, the Food and Drug Administration issued a patient safety alert about complications with mesh, noting that some products had already been recalled.

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FDA issues memory loss, diabetes warning about Crestor and statins

The Food and Drug Administration has issued a Crestor warning that links the drug to an increased risk of high blood sugar, diabetes and memory problems. The FDA also warned about a risk of these side effects with two similar drugs, Lipitor and Zocor.

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FDA Cautions On Memory, Diabetes Side Effects In Cholesterol-Lowering Drugs

The Food and Drug Administration just added new language telling consumers about potential memory problems and an increased risk of high blood sugar for patients on statin cholesterol-lowering medicines. These medicines, including Lipitor, Zocor, and Crestor, are the most-prescribed class of drug in the country.

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The billion-dollar battle over premenstrual disorder

Doctors at work on the fifth edition of the Diagnostic Manual of Mental Disorders — the American Psychiatric Association’s bible for mental-health professionals — are weighing whether to add Premenstrual Dysphoric Disorder (PMDD) — a more severe form of PMS — to the volume’s list of officially recognized psychiatric disorders. The current criteria being proposed for PMDD includes mood swings, marked irritability or anger or increased interpersonal conflicts, feelings of hopelessness, marked anxiety and decreased interest in usual activities.

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Glenmark Generics recalls birth control pills

Glenmark Generics recalled seven lots of birth control pills due to packing them in the wrong order in the supply. The ingredients of the pills are norgestimate and ethinyl estradiol. The amount of pills or packages recalled was not announced. According to the company, in some of the packages, pills were not inserted in the proper sequence.

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Study says antipsychotic drugs should be avoided in elderly

Some antipsychotic medication may increase the risk of death in patients with dementia more than others, according to US research. A study (PDF), published on the BMJ website, argued that antipsychotics should not be used “in the absence of clear need”. Researchers in the study examined the safety of the drugs Abilify, Geodon, Haldol, Zyprexa, Risperdal and Seroquel.

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Document: 2009 E-Mail on Recall DePuy Hip Device

On Aug. 21, 2009, Pamela Plouhar, V.P. for worldwide clinical affairs at DePuy, sent the following e-mail to three company executives. The disclosures in the e-mail contrast with statements made in recent years by the company, which continued to market the device in Europe (and a related model in the United States) before announcing a recall in 2010.

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Flawed DePuy hip implant had early FDA notice

A year before recalling DePuy hip replacements in 2010, an executive at Johnson & Johnson reported in an internal e-mail that the Food and Drug Administration had refused to approve the device, after reviewing company studies that showed it had failed prematurely in “significant” numbers, requiring repeat surgeries for patients.

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Abbott Faces More Investigations, Lawsuits Over Depakote Marketing

Abbott Laboratories is facing fresh legal challenges in connection with its sales and marketing of anti-seizure drug Depakote. Attorneys general in eight states have formed a committee to investigate whether Abbott’s Depakote sale and marketing violated various state consumer-protection and other laws, the company disclosed Tuesday.

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Obama birth control compromise distracts from issue of whether the pill is safe, activists say

President Obama’s recently offered a compromise in the controversy regarding whether religious institutions should be required to offer birth control to employees as part of their health care coverage. Workers at religious institutions, he said, will get free contraception directly from health insurance companies instead of their employer. However, the compromise does not address concerns about the safety of birth control pills such as Yaz and Yasmin, which have been linked to an increased risk of blood clots.

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