Sunday, August 2, 2009

Antidote for Rhematoid Arthritis Drug Bone Fractures

Approximately 50 percent of people who are prescribed chronic glucocorticoid therapy for rheumatoid arthritis will eventually have an osteoporotic fracture. The use of glucocorticoid medications can lead to a reduction in bone formation.

Eli Lilly and Company's drug Forteo has been FDA approved as a new use to treat osteoporosis along with chronic glucocorticoid therapy drugs. Lily said Forteo is supposed to counter the effects of these glucocorticoid therapy drugs while stimulating bone formation.

Lilly provided data from a clinical study demonstrating the effectiveness of the product.

Thursday, July 2, 2009

PPI drugs and drug dependency

Morale of the story: If you don't need PPI drugs (proton pump inhibitors), don't take them.

According to a clinical trial, healthy people without any history of acid reflux or heartburn problems took PPIs for eight weeks which lead to developing symptoms for PPIs thusly a dependency on the drug.

(Why would healthy people participate in such a clinical trial?)

PPIs like Aciphex, Prilosec, Prevacid, Nexium, and Protonix are among the most widely used prescription medications in the world.

Proton pump inhibitors are highly effective treatments for acid reflux symptoms, but taking prescription-strength dosages of the drugs for just a few months can lead to dependency, new research suggests.

By week 12, when the PPI group had been off active treatment for four weeks, about 21% reported symptoms of heartburn, indigestion, or acid regurgitation, compared to slightly less than 2% of those who never took a PPI.

The study appears in the July issue of the journal Gastroenterology.

Monday, May 11, 2009

PPI Health Concerns

According to the National Prescribing Service Limited, health professionals are advised to cut down proton pump inhibitor (PPI) therapy and/or stop it when appropriate.

PPIs are regarded as safe medicines, but evidence suggests they can cause serious adverse effects such as a rare hypersensitivity reaction which has been reported following the use of PPIs. Recent studies have indicated that PPI use may increase the risk of Clostridium difficile infection and community-acquired pneumonia.

By using a step-down approach, the beneficial effects of PPI therapy are retained and the risk of adverse effects is reduced. Patient symptoms can be controlled using a lower dose, either daily or when symptoms occur.

The NPS therapeutic program on PPIs reinforces the following:

- A 4-8 week course of standard-dose PPI therapy should be used to control symptoms of gastro-esophageal reflux disease (GERD)
- A step-down approach should be adopted to reach the lowest dose and frequency of PPIs - Serious PPI side effects can occur
- Lifestyle changes can help reduce the need for PPI therapyPatients should make lifestyle changed to avoid food and drinks that exacerbate their symptoms.

The NPS is an independent, non-profit organization for Quality Use of Medicines funded by the Australian Government Department of Health and Ageing.

If only the FDA were as prudent...

Tuesday, March 10, 2009

Osteoporosis and Dangerous Drugs

Here's an osteoporosis drug that isn't approved yet and has been trying for the past several years to be approved.

Pfizer submitted the current application for lasofoxifene on December 18, 2007. On September 8, 2008, an FDA scientific advisory panel voted 9-3 (with one abstention) that there is a population of postmenopausal women with osteoporosis in which the benefits of lasofoxifene likely outweigh the risks. FDA is not required to follow the advice of the panel.

This doesn't sound convincing to me.

Osteoporosis drugs are not without terrible side effects and drugs taken for gastric ulcers can cause osteoporosis.

Friday, March 6, 2009

A new pill called Kapidex, for chronic heartburn caused when excess stomach acid backs up into the esophagus, was cleared by the Food and Drug Administration.

Kapidex is a new version of Prevacid.

The new formulation releases the drug in two separate stages in order to spread out the dose more evenly.

Prevacid loses its proprietary patent in November 2009. Prevacid and drugs of its genre (proton pump inhibitors) are the best selling prescribed drugs. (Blogger’s note: Americans must have a lot of heartburn. Is there no remedy without drugs?)

Regulators took three months longer than scheduled to decide whether to approve the new medicine, dexlansoprazole. (Blogger’s note: Why?)

Tuesday, March 3, 2009

Generic Relief for Peptic Ulcer Sufferers

Mylan Inc. received final FDA approval for a generic version of the heartburn drug Prilosec.

The U.S. Food and Drug Administration approved an abbreviated new drug application for omeprazole delayed-release capsules, 40 mg.

The capsules are approved for the treatment of peptic ulcers and gastroesophageal reflux disease.

Prilosec is made by AstraZeneca PLC. Prilosec has serious side effects.

Mylan's shares went up.

Sunday, March 1, 2009

Generic Prilosec Hits the Market

The Food and Drug Administration has approved Impax Laboratories Inc.’s Abbreviated New Drug Application for a generic version of Prilosec.

Prilosec is marketed by AstraZeneca for the treatment of duodenal/gastric ulcers and gastro-esophageal reflux disease (GERD).

The new approval is for 40-mg delayed-release capsules.

Prilosec is not without serious side effects.