Trusted Pharmacy Blog|New Drugs, Drug News, Health, Medications, Diseases

These days, first-line therapy for Helicobacter pylori infection consists of a proton pump inhibitor (PPI) plus an antibiotic, such as clarithromycin drug (Biaxin, Abbott) and  generic  amoxicillin (Amoxil, GlaxoSmithKline) or a nitroimidazole. However, recent studies have suggested that eradication rates might be dropping because of antibiotic resistance.

Researchers from Turkey compared one-week and two-week treatments in 80 patients with dyspepsia. The one-week group (PAC-1) received 40 mg of pantoprazole drug(buy) (Protonix, Wyeth), 1,000 mg of amoxicillin drug(buy), and 500 mg of (order) clarithromycin twice daily. The second group (PAC-2) received the same treatment for two weeks.

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Researchers at Stanford University School of Medicine have identified some distinctive proteins in the blood of patients with Alzheimer’s disease (AD) that could be used to diagnose the condition more effectively.

Doctors generally diagnose AD only by eliminating other possible causes of mental decline. Only after a patient dies can surgeons examine brain tissue to look for the protein plaques and tangles that are the hallmark of the disease.

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The FDA is planning to launch a drug research center to be paid for by the companies it regulates. The goal is to improve the development of drugs and medical devices.

However, some consumer advocates suggest that the new partnership might increase the FDA’s vulnerability to industry influence. Some critics worry that drugs might be developed more cheaply, thus improving pharmaceutical manufacturers’ profits, but might not necessarily result in safer and less expensive drugs for consumers. Some also say the FDA is too accommodating to drug companies.

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Generic drugs may soon get speedier FDA reviews. New policies have been designed to reduce the backlog of more than 1,300 drugs awaiting approval.

A lack of resources has prevented the FDA’s Office of Generic Drugs from keeping pace with the growing number of applications for copies of medications whose patents expired or were challenged.

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Under a bill that President Bush has signed into law, the FDA will have broader responsibilities to ensure the safety of prescription drugs. For example, the agency’s focus would shift from experimental drugs pending approval to those already on the market. The FDA would have more power to require drug companies to perform additional studies, to fine companies for not completing follow-up studies, and to require fees from drug companies and medical device makers to cover the costs of hiring, updating technology, and expanding safety monitoring. At the same time, the FDA would be required to become more active in its surveillance of new safety problems with drugs.

(Source: Associated Press, September 27, 2007.)

The FDA is tightening standards for levothyroxine sodium (e.g., generic Synthroid, Abbott), to ensure that the drug’s potency is retained over its entire shelf life.

More than 13 million patients use levothyroxine to treat underactive thyroid glands and other thyroid conditions.

Currently, these thyroid products are allowed a potency range of 90% to 110%. The FDA is mandating a stricter range of 95% to 105%. Manufacturers and marketers have two years to comply with the revised specification.

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The FDA has approved updated labeling for cetuximab (Erbitux, ImClone/ Bristol-Myers Squibb) to include overall survival data. Cetuximab is indicated for the treatment of EGFR-expressing, meta-static colorectal carcinoma after unsuccessful regimens of both irinotecan (Camptosar, Pfizer) and oxaliplatin (Eloxatin, Sanofi-Synthelabo). As a single agent, cetuximab is also indicated for the treatment of EGFR-expressing metastatic colorectal cancer in patients intolerant to irinotecan-based regimens.

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