Posts Tagged 'FDA'

FDA reviewer recommends against Pfizer drug

A U.S. Food and Drug Administration medical reviewer recommended the agency not approve tafamidis, a drug developed by a Pfizer Inc. subsidiary to treat a rare genetic disorder that affects the nervous system. The reviewer said there was “inadequate” evidence the drug works, according to the Wall Street Journal.

This is the second recent setback for Pfizer. Last week, the New England Journal of Medicine published a study that found the pharmaceutical giant’s popular antibiotic azithromycin, sold under the brand name continue reading...

FDA says azithromycin increases risk of heart death

The U.S. Food and Drug Administration has notified healthcare professionals of a study published in the New England Journal of Medicine that found patients taking a widely used antibiotic are at higher risk for potentially deadly heart problems.

The study concerns Zithromax, the brand name for azithromycin, which is commonly prescribed for pneumonia and other common infections. The FDA announcement emphasizes that patients taking the drug shouldn’t stop without talking to their doctors.

According to the FDA announcement, azithromycin belongs to a ...

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Popular “Z-Pack” antibiotic Zithromax doubles risk of death

A study published in the New England Journal of Medicine found that the popular antibiotic Zithromax caries a small but significant risk of sudden death from heart problems. Patients who took a five-day course were more than twice as likely to die than people taking different antibiotics. This risk was even higher for people who already had cardiovascular disease.

Zithromax is the brand name for azithromycin, which is used to treat common infections such as bronchitis and pneumonia. Its popularity is ...

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FDA panel on hip implants seeks public input

A federal Food and Drug Administration panel examining the safety of metal-on-metal hip implants is inviting members of the public to comment on the devices.

The FDA’s Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee has scheduled sessions for June 27 and 28 to examine the question of whether the hip implants should be subject to new testing standards and review requirements before going on the market in the U.S.

The agency is responding to thousands of complaints about ...

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Many transvaginal mesh implants were unnecessary, caused complications

A Consumer Reports article on the hazards of certain medical devices recommends that patients protect themselves by considering what alternatives are available.

In the case of transvaginal mesh implants, for example, patients should ask their doctors what will happen if they don’t get the devices. According to the report, many women who received transvaginal mesh for pelvic organ prolapse – where the pelvic organs move out of alignment because of weakened muscles – never needed the surgery.

The report quotes Daniel S. ...

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FDA warns of mixing statins, protease inhibitors

The federal Food and Drug Administration put out a warning on March 1 about mixing protease inhibitors, used to treat HIV and hepatitis C, and certain types of the cholesterol-lowering drugs called statins.

The combination of the drugs can cause a form of muscle injury called myopathy, according to the FDA. The most serious form of myopathy, called rabdomyolosis, can lead to deadly kidney failure.

According to the FDA, labels for both the protease inhibitors and the affected statins are being updated ...

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