30 août 2007

FDA Warns Against Codeine for Mothers of Nursing Infants

Medications containing codeine given to breast-feeding mothers who rapidly metabolize codeine into morphine may cause adverse effects in their infants, according to an alert sent today from FDA.

Codeine is generally considered safe for use in nursing mothers; however, last year, a healthy 13-day-old breast-fed infant died from very high levels of morphine received through breast milk. The mother was taking codeine at a dose lower than that usually prescribed for episiotomy pain, but genetic testing revealed that the infant's mother was an ultrarapid metabolizer of codeine.

According to the FDA, depending on ethnicity, approximately anywhere from 1 to 28 per 100 individuals rapidly metabolize codeine. Genetic testing is the only way to determine whether someone is a rapid metabolizer; an FDA-cleared test for determining a patient's CYP2D6 genotype is available, but there is limited information about using this test to characterize codeine metabolism. In addition, the test result is insufficient in predicting whether too much morphine will be passed along in a mother breast-feeding an infant.

The FDA recommends that patients be made aware of the signs of morphine overdose. Patients should be told to contact their clinician if a baby shows signs of increased sleepiness (ie, sleeping for more than 4 hours at a time), limpness, or difficulty nursing or breathing.

Tiré de Medscape

17 août 2007

Permanent Implant (Essure Permanent Birth Control) for Prevention of Pregnancy

On June 15, the FDA approved a premarket application for a third-generation implant (Essure Permanent Birth Control, Conceptus, Inc) for permanent birth control. The approval covered design and material changes to the microinsert, delivery catheter, and introducer of the system. The modifications were physician recommended and intended to reduce the number of steps required during an implantation procedure.

Originally approved by the FDA in 2002, the implant was developed as a less invasive alternative to tubal ligation for women. During the procedure, a hysteroscope is used to guide a soft microinsert through the vagina, cervix, and uterus into the fallopian tubes. Once placed in the fallopian tubes, the device elicits tissue growth in and around the microinsert, forming a blockage that prevents fertilization within approximately 3 months. The resulting sterilization is not reversible.

According to Conceptus, approximately 700,000 tubal ligations and 400,000 vasectomies are performed annually in the United States.

Tiré de Medscape

What Happens to Epinephrine After the Expiration Date?

Is it acceptable to use epinephrine that is older than the expiration date stamped on the container? What happens to it after that time?

The stability of a drug is defined as the time that the product will meet the specifications outlined in the drug monograph, including identity, strength, quality, and purity. The monograph specifications apply throughout the shelf life of the product, which is noted by the expiration date. Manufacturers must demonstrate that the products maintain their stability, under noted storage conditions, throughout the life of the product.

Stability includes considerations about the activity of the product and about its physical appearance. The stability of a product is influenced by storage conditions: light, temperature, air, humidity, and package components.

There are 5 general types of stability:

Chemical: Active ingredient(s) maintain chemical integrity and labeled potency, within specified limits.

Physical: Product retains the original appearance, palatability, uniformity, dissolution, and suspendability.

: The sterility/resistance to microbial growth is retained, and the microbial effect is within a specified range.

Therapeutic: The therapeutic effect of the product remains unchanged.

Toxicologic: There is no significant increase in toxicity.

Drugs degrade or decompose for various reasons, including chemical reactions, oxidation (exposure to air or chemicals), photochemical decomposition (exposure to light), and interaction with other package components. Epinephrine is one product that is readily oxidized, and it is packaged by the manufacturer to minimize oxidation.

Epinephrine, as labeled, contains between 90% and 115% of the labeled amount of drug. Several references note that the product should not be used if it is pink or brown or if it contains a precipitate. The change in color is evidence that oxidation has occurred. The basic formulation of epinephrine is buffered and contains antioxidants to maintain stability if protected from light, heat, and air.

Specific to your question, there is a warning note in Remington's to "not to use any epinephrine dosage form if it is brown or pink in color or contains a precipitate; a hallucinatory reaction may occur." Other references checked did not mention specific toxic effects of expired epinephrine.

When solutions of epinephrine oxidize in the presence of oxygen, especially in neutral or alkaline solutions, a red color is formed. This red substance is a pigment called adrenochrome. It has no medical use, but it is noted to have been used experimentally to produce psychic effects.

There are reports from the 1950s and 1960s referring to psychomimetic symptoms of adrenochrome, but they were not validated in the literature. In fact, these references would not meet the rigor of today's research. Overall, adrenochrome is not a very stable product, which would minimize any effects of exposure.

In summary, the manufacturer-provided expiration date reflects the shelf life of the product, during which it will meet the various specifications provided in the drug monograph. After this time, the product will still have some activity, but it is not proven to meet the given standards. The integrity of any product after the manufacturer's expiration date is questionable, and the product should not be used.

Tiré de Medscape

02 août 2007

Le cannabis serait pire que la cigarette

Les effets de la consommation de cannabis seraient plus nocifs que ceux causés par la cigarette.

Une étude effectuée sur 339 adultes a permis de constater que de fumer un joint de pot serait comparable à fumer 2,5 à 5 cigarettes au niveau pulmonaire.

Le niveau de toxicité de la marijuana serait plus de 3 fois plus élevé que celui de la cigarette.

Ainsi, les consommateurs de pot souffrent de plusieurs problèmes respiratoires tels que la toux, l'expectoration et l'oppression de la poitrine.

Selon les chercheurs, c'est au niveau des bronches pulmonaires que le cannabis fait ses dommages, en obstruant les voies respiratoires.

De plus, toujours selon l'étude, les dommages seraient proportionnels à la consommation; plus on consomme, plus les effets nocifs seraient importants.

tiré de Sympatico MSN