There is a fake "morning after" pill on the market and the U.S. Food and Drug Administration (FDA) is warning the public about it. The drug's name is called Evital and no such product has been approved to date and it may not be safe or effective in preventing pregnancy although approved in South America. Uh oh.

Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to your health.

FDA takes all reports of suspect counterfeits seriously and, in order to combat counterfeit medicines, is working with other agencies and the private sector to help protect the nation's drug supply from the threat of counterfeits.

The 1.5 mg, single-tablet packaging calls the product an "anticonceptivo de emergencia," purportedly manufactured by Fluter Domull. The company does not have a website, but does have a Facebook page with little information about the product.

An FDA spokesperson said the pill is approved in the Dominican Republic, and the agency is concerned that the pill is being distributed in Hispanic communities in the U.S.

The agency advised patients to contact a doctor if they've taken the medication and experienced any adverse effects, adding that there are other options for emergency birth control, both prescription and over-the-counter. Those include Plan B and ulipristal acetate (Ella).

The morning-after pill can be used after a pair has had unprotected sex. Depending on where a woman is in their menstrual cycle, the morning-after pill can prevent or delay ovulation, block fertilization, or keep a fertilized egg from implanting in the uterus. One should not take the morning-after pill if they are already pregnant.

Counterfeiting can apply to both brand name and generic products, where the identity of the source is mislabeled in a way that suggests that it is the authentic approved product. Counterfeit products may include products without the active ingredient, with an insufficient or excessive quantity of the active ingredient, with the wrong active ingredient, or with fake packaging.

Also look out for internet sales. Buying prescription and over-the-counter drugs on the Internet from a company you don't know means you may not know exactly what you're getting.

There are many websites that operate legally and offer convenience, privacy, and safeguards for purchasing medicines. But there are also many "rogue websites" that offer to sell potentially dangerous drugs that have not been checked for safety or effectiveness. Though a rogue site may look professional and legitimate, it could actually be an illegal operation.

These rogue sites often sell unapproved drugs, drugs that contain the wrong active ingredient, drugs that may contain too much or too little of the active ingredient, or drugs that contain dangerous ingredients.

The FDA continues to proactively protect consumers from counterfeit drugs. The agency is working with drug manufacturers, wholesalers, and retailers to identify and prevent counterfeit drugs. FDA also is exploring the use of modern technologies and other measures that will make it more difficult for counterfeit drugs to get mixed up with, or deliberately substituted for, safe and effective medicines.

Sy Kraft

View drug information on ella.

A fictionalised account of the lives and experiences of home-visiting GPs from around the globe has just been published by the Royal College of General Practitioners (RCGP).

Secrets from the Black Bag is presented as a series of interconnecting chapters in 11 voices. The stories give an insight into the lives of these GPs as they speak of their delights, their fears, their challenges and successes.

The author, Susan Woldenberg Butler, developed the stories following a number of interviews with home-visiting general practitioners from around the world.

Dr Alec Logan, Deputy Editor of the British Journal of General Practice said:

"These stories demonstrate the varied nature of general practice in a highly readable format. As doctors adapt to the changing face of general practice in the 21st century it is essential that we do not lose sight of the importance of the doctor-patient relationship."

Secrets from the Black Bag by Susan Woldenberg Butler is available from the Royal College of General Practitioners, priced �15.00. rcgp/acatalog

The Royal College of General Practitioners is the largest membership organisation in the United Kingdom solely for GPs. It aims to encourage and maintain the highest standards of general medical practice and to act as the "voice" of GPs on issues concerned with education; training; research; and clinical standards. Founded in 1952, the RCGP has over 23,000 members who are committed to improving patient care, developing their own skills and promoting general practice as a discipline.

Promoting excellence in family medicine rcgp

The U.S. Food and Drug Administration proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.

The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.

"With this proposal, FDA's goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit," said Rear Admiral Sandra Kweder, M.D., Center for Drug Evaluation and Research, FDA. "This proposal would help make drug labeling a better communication tool, and would potentially have a huge impact on public health and well being for women."

There are about six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Additionally, women with pre-existing medical conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs to treat those conditions during pregnancy.

The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.

In the 1990s, the FDA recognized the shortcomings of pregnancy and breastfeeding information in prescription drug labeling and began reviewing ways to improve the information. The agency held public meetings and focus groups to obtain comment on the current labeling from health care professionals and scientific experts. Current labeling uses a letter category system to describe the risks of drug use during pregnancy. Stakeholders have said the letter category system leads to an inaccurate and overly simplified view of these risks, and does not facilitate updating of labeling as new information becomes available.

The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections:

- The first section, called the "Fetal Risk Summary," would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: "Human data indicate that (name of drug) increases the risk of cardiac abnormalities." This would be followed by a summary of the most important data on the drug's effects.

- Another section, called "Clinical Considerations," would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.

- The third section, under the heading "Data," would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.

The pregnancy section would also include information about whether there is a pregnancy exposure registry for the drug. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women.

The lactation (breastfeeding) section of prescription drug labeling would use the same format as the pregnancy section. The lactation section would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs will be phased in gradually under FDA's recent Physician Labeling Rulemaking.

Electronic comments can be submitted within 90 days via the Federal Documents Management System/eRulemaking portal at regulations. The FDA will carefully consider the comments in preparing a final rule.

For more information, visit here.

fda

The American Academy of Child and Adolescent Psychiatry (AACAP) is proud to announce its new practice parameter on the use of psychotropic medications in children and adolescents.

"The reason for the parameter was to ground prescribers of psychotropic medication in the best practice principles," states principle author John Walkup, M.D. "This is not a standard of care document and is not meant to reduce prescribing. Rather, it is a call for action to create a systematic and comprehensive approach to using medications in children safely and effectively."

The parameter specifically outlines best practices for: psychiatric and medical assessment, development of the treatment and monitoring plan, educating both the patient and family about the disorder and treatment, implementation of the treatment plan and management of medication modification plans.

The full practice parameter is featured in the Journal of the American Academy of Child & Adolescent Psychiatry, September 2009 - Volume 48 - Issue 9, pages 961 - 973.

Source
American Academy of Child and Adolescent Psychiatry

Victims of the on-going conflict in Colombia not only suffer from the direct consequences of violence caused by the conflict but also from social and institutional stigma and neglect, according to a report released today by the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF). In the report, titled "Three Time Victims," MSF documents how violence, stigma, and neglect impact the mental health of people living in Caquetá Department of southern Colombia, and calls for mental health services to be adapted to the needs of this vulnerable population.

"Our teams witness the appalling reality endured by most of the population in Caquetá," said Teresa Sancristóval, head of MSF operations in Colombia. "On the one hand, people are exposed to the violence perpetrated by the different armed groups, and on the other hand authorities and society fail to provide them with the attention they deserve. The consequences of this situation for mental health include severe psychological suffering that should be addressed by authorities."

Between March 2005 and September 2009, MSF saw 5,064 patients in its mental health project in Caquetá. Of these patients, 49.2 percent had been directly exposed to the conflict, caught in the fighting between armed groups, as well as violent incidents involving threats, injuries, forced recruitment, displacement, movement restrictions, or killings of family members.

The victims of the conflict not only endure the consequences of direct violence, but also face social stigma. "In Colombia, the stigma surrounding those affected by the conflict forces them to keep silent about their condition and suffering, which prevents their social integration and recognition and sense of belonging," said María Cristóbal, MSF mental health officer in Colombia. This prevents people's access to employment, housing, education, and health.

In addition to direct violence and social stigma, victims are often excluded from receiving state support through social services. This institutional neglect can be clearly seen through the scant recognition of the forced displacement phenomenon in Colombia.

"The Colombian government should live up to its responsibility in terms of tending to the needs of these people," said Sancristóval. "Based on our experience in Caquetá, we can say that offering mental health care with limited resources in conflict contexts is possible and that this care can effectively improve patients' conditions."

Source:
Doctors Without Borders