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What's in the news:
There is a misconception that generic drugs
can vary by as much as 20% from brand-name drugs. Some take this to
mean that the amount of drug in the product can vary by 20% and others
think it refers to the amount of drug absorbed or the average blood
levels. These assumptions are not correct. The difference between most
bioequivalent products is usually less than 4%. The "20% rumor" originates
from a lack of understanding of the statistical tests required to show
bioequivalence. A generic drug must show that the 90% confidence interval
of the mean rate and extent of absorption is within 20% of the brand.
The confidence interval is a statistical test to indicate how much results
vary from the mean.
The important point is that these results cannot
vary much for the confidence interval to fit within the 20% range. Patients
should be reassured that generic equivalents produce the same therapeutic
results in the vast majority of cases. Generic drugs are tested against
the brand and not to each other. In rare cases this could mean slightly
more variation amongst different generics. For some very delicately
controlled patients on narrow therapeutic index drugs, such as antiepileptic's
and warfarin, staying with the same generic manufacturer for each refill
is a good idea.
Pharmacist's Letter: July 2008; Vol: 24, No. 7
http://www.pharmacistsletter.com
Usage of medications from other countries increases during summer travel. Drug names often vary between countries and these foreign drugs can lead to mix-ups and legal problems. In Canada, omeprazole is Losec instead of Prilosec and cetirizine is Reactine, not Zyrtec. Simvastatin has more than ten different names in Mexico and in India atorvastatin has more than thirty different names. Some brand names in foreign countries are similar to U.S. names. Medral is omeprazole in Mexico but Medrol is methylprednisolone in the U.S. Sometimes the brand name is the same but the active ingredient is different. Kaopectate is bismuth subsalicylate in the U.S, attapulgite in Canada and kaolin/pectin in Mexico. Generic names can also be different, some examples are: Albuterol is salbutamol in most other countries and acetaminophen is sometimes called paracetamol. Also prescription status differs between countries. In Canada, people can get low-strength codeine products and methocarbamol-containing muscle relaxants without an Rx. In Mexico, an Rx is not required for most non-controlled drugs such as amoxicillin, Lipitor, and Viagra but an Rx is needed for pseudoephedrine, zolpidem, diazepam, and other controlled drugs and illegal possession can lead to jail time. Importing prescription drugs is illegal in most cases. This law is not always enforced, especially for patients bringing up to a 90-day supply of non-controlled meds for personal use. Foreign drugs aren't necessarily cheaper, especially now that the U.S. dollar is down and shipping costs are up. It is best that patients travel with enough prescription medications for their entire stay and to keep them in their original labeled prescription container.
Pharmacist's Letter: July 2008; Vol: 24, No. 7
http://www.pharmacistsletter.com
Product Alerts:
Laquinimod is a novel once-daily, orally
administered immunomodulatory compound that is being developed as a
disease-modifying treatment for RRMS. Active Biotech developed laquinimod
and licensed it to Teva Pharmaceutical Industries, Ltd. in June 2004.
A Phase IIb study in 306 patients was recently published in The Lancet
and demonstrated that an oral 0.6 mg dose of laquinimod, administered
daily, significantly reduced MRI disease activity by a median of 60
percent versus placebo in RRMS patients. Laquinimod also showed consistent
and robust effect on all secondary MRI endpoints. In addition, the study
showed a favorable trend toward reducing annual relapse rates and the
number of relapse-free patients compared with placebo. Treatment was
well tolerated.
In addition to the efficacy that laquinimod has
shown in Phase II RRMS clinical trials, laquinimod has demonstrated
potent therapeutic efficacy in preclinical models of other autoimmune
diseases such as rheumatoid arthritis, insulin-dependent diabetes mellitus,
Guillain Barr? Syndrome, lupus and Inflammatory Bowel Disease. The broad
profile of efficacy in animal models of inflammatory diseases suggests
that laquinimod affects a pivotal pathway of inflammation and autoimmunity.
Teva expects to initiate the clinical development of laquinimod for
Crohn's disease and Lupus Nephritis in the near future. May 4, 2007
- The US Food and Drug Administration (FDA) has approved first-time
generic formulations for zolpidem tartrate 5-mg and 10-mg tablets for
treatment of insomnia; sertraline hydrochloride tablets 150 mg and 200
mg for treatment of depression; and nimodipine 30-mg soft gelatin capsules
for improved neurological outcome following subarachnoid hemorrhage.
Medical News Today, July 17, 2008
http://www.medicalnewstoday.com/articles/115259.php
Patients who lack the ApoE4 gene have a predisposition to developing Alzheimer's, especially earlier in life. Immunotherapy, is an emerging frontier for a variety of different diseases, involves stimulating the body's own immune system to fight various conditions, including cancer. One-half to two-thirds of the research push in Alzheimer's is aimed at amyloid therapy and especially immunotherapy. Bapineuzumab is a humanized monoclonal antibody which binds to and might be able to eliminate beta amyloid peptide, which accumulate as plaques in the brains of people with Alzheimer's. The drug delivers antibodies to beta amyloid. Most experts in the field of Alzheimer's believe that the build-up of beta-amyloid proteins in the brain are responsible for the disease. Researchers noted statistically significant improvements in patients without the ApoE4 gene. The therapy did not appear to have a statistically significant benefit in patients with the gene, although there was some benefit. A large, phase 3 study is currently underway, although even if all goes well, the drug could take almost four years to reach the market.
Health Day News, 27 June 2008
http://news.yahoo.com/s/hsn/20080629/hl_hsn/alzheimersdrugshowsearlypromise
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