Applied Clinical Pharmacokinetics By Larry A. Bauer

                                                


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pharmacovigilance most expected Questions

                                                               

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Facts about Generic Drugs

Today, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent through 2015. Here are some facts about generic drugs:	Click image to view larger graphic.

  

 

FACT: FDA requires generic drugs to have the same quality and performance as brand name drugs.  

• 
  When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable. 

• Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs do not need to contain the same inactive ingredients as the brand name product.  

• The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured.  If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same. 

• Through review of bioequivalence data, FDA ensures that the generic product performs the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release. 

• All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products.

FACT:  Research shows that generics work just as well as brand name drugs.

• A study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts. There was no evidence that brand name heart drugs worked any better than generic heart drugs.

FACT:    FDA does not allow a 45 percent difference in the effectiveness of the generic drug product. 

• FDA recently evaluated 2,070 human studies conducted between 1996 and 2007. These studies compared the absorption of brand name and generic drugs into a person’s body. These studies were submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand name was 3.5 percent[2]. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name drug. In fact, there have been studies in which brand name drugs were compared with themselves as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison.
• Any generic drug modeled after a single, brand name drug must perform approximately the same in the body as the brand name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product.

FACT: When it comes to price, there is a big difference between generic and brand name drugs. On average, the cost of a generic drug is 80 to 85 percent lower than the brand name product.

• In 2010 alone, the use of FDA-approved generics saved $158 billion, an average of $3 billion every week.

FACT: Cheaper does not mean lower quality. 

• Generic manufacturers are able to sell their products for lower prices because they are not required to repeat the costly clinical trials of new drugs and generally do not pay for costly advertising, marketing, and promotion. In addition, multiple generic companies are often approved to market a single product; this creates competition in the market place, often resulting in lower prices.

FACT: FDA monitors adverse events reports for generic drugs.

• The monitoring of adverse events for all drug products, including generic drugs, is one aspect of the overall FDA effort to evaluate the safety of drugs after approval. Many times, reports of adverse events describe a known reaction to the active drug ingredient. 

• Reports are monitored and investigated, when appropriate. The investigations may lead to changes in how a product (brand name and generic counterparts) is used or manufactured.  

FACT:  FDA is actively engaged in making all regulated products – including generic drugs – safer.

• FDA is aware that there are reports noting that some people may experience an undesired effect when switching from brand name drug to a generic formulation or from one generic drug to another generic drug. FDA wants to understand what may cause problems with certain formulations if, in fact, they are linked to specific generic products.  

• FDA is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur. The Agency does not have the resources to perform independent clinical studies and lacks the regulatory authority to require industry to conduct such studies. FDA will continue to investigate these reports to ensure that it has all the facts about these treatment failures and will make recommendations to healthcare professionals and the public if the need arises. 

Miracles of Homoeopathic mother tinctures

In Homoeopathic Medical Science, since the discovery of the system, Original Mother Tinctures were used for the treatment, by the originator of the medical system, Dr. C.F.S. Hahnemann.

                    

This practice is still in use by the Homoeopaths, even today. Homoeopathy have a large number of Mother tinctures for use in diseases and in ailments with great success. Find here the descriptions of some Mother tinctures, which are total safe in use.

Homoeopathic mother tinctures are prepared from the following kingdoms:

• Vegetables
• Minerals
• Animals
• Imponderablias
• Nosodes

Preparations

• Dr. Hahnemann have directed, how to prepare mother tinctures, in his work “ Materia Medica Pura”
• Alcohol or distilled water, is used to prepare the mother tincture or mother solutions
• Under the Hahnemannian guidelines, Mother tinctures are prepared for treatment purposes

Prescribed doses : Q / MTs

• For Adult : 10 to 15 drops
• For New born: One drop in two spoonful, make four doses / ¼ drops
• Infants: One drop
• Children : 2 to 4 drops
• Adult children : 5 to 7 drops
• Mother tinctures should be taken on empty stomach, unless not specified
• This is a general prescribing mode of Mother tinctures

Safe Use

• Mother tinctures are totally safe in use, as  is indicated, for any disease condition
• After, remedy name “Q” or “MT” or “Mother Tincture” specifically suffix, to indicate , that the remedy is in Mother tincture form

Fast actions

• Mother tinctures have very fast actions
• Being prepared in Alcohol, the molecules of the ingredient of herbs etc , absorbed by the stomach and intestines quickly
• Action of the medicine starts within 3 to 4 minutes
• These actions remains for several hours

Alternations of Mother Tinctures         

• Mother tinctures can be given in alternation.
• To cover the several disease conditions, MTs are prescribed single , two, three and even more in alternation.
• Today Homoeopaths, mixes Mother tinctures according to the need of patient’s complaints, which could be 2 to 10 in numbers.
• Mother Tinctures are sure-shot prescribing for disease conditions and never fails.

Advantages of mother tincture

• It is used in most cases of emergency or acute cases where homeopathic physician require enough time to take out indicated medicine. (Blood pressure, acute stone pain, dysmenorrhoea, acute abdomen)
• It is used as a palliative medicine for many cases.
• It has very fast actions as compare to medicines
• Its action starts within 3-4 minutes and last for several hours.
• Mother tinctures are prepared from alcohol so as it is readily absorbed in stomach and intestine.
• It is a very safe type as it has lowest potency than any other medicine. It is a less diluted tincture.
• It is very sure indication with lesser reaction and failure
• It also helps patient in weaning period of their medication.It helps them to minimize withdrawal symptoms and keep them permanently away from addictions.Eg-lobelia inflate helps them to wean asthmatic medication as it provides support to lung function.
• Mother tincture is also indicated in bruises as a cold compressor.
• It is helpful in preparation of many homeopathic tonics and external application along with proper homeopathic medicine internally.( according to aphorism no 284. Many of mother tinctures like cantharis, calendula are used as first aid in many external causes like burns, injuries along with internal medicines. )
• Mother tinctures like arnica Q, jaborandi Q, and camphor Q are also used to prepare hair oil for special care of hair along with internal use of homeopathic medicine.
• Mother tincture like calendula are used as an antiseptic in wounds cases, it is called as homeopathic “disinfectant” and it is mostly used with good results.
• There are numerous numbers of mother tinctures (no limitation) so as to select according to each individual case.
• It is useful in any disease if it depends upon symptom similarity.

Disadvantage

• Mother tinctures have chances of emerging new pathological symptoms as they are in crude form.
• Long use of mother tinctures containing plant enzymes, poisonous alkaloids, glycolides and other phyto chemical ingredients are dangerous to health.
• Mother tinctures are not permanent solution for any complaint; they are only for temporary and emergency use.
• Mother tincture are not capable to pass complete pure energy to activate dearrange vital force as it contains drug molecules of original drug and it is not fully diluted.
• If our selections of mother tinctures are not similar to disease symptom then it considers as anti homeopathy.

Books written by Indian authors on medical teaching and training

                                     

A list of Books written by Indian Authors in Medical Education

• Verma K, D’Monte B, Adkoli BV, Nayar U, (eds). Inquiry Driven Strategies for innovation in Medical Education. New Delhi: AIIMS, 1991.
• Verma K, Nayar U, Adkoli BV (eds). Inquiry Driven Strategies for innovation in Medical Education: Curricular Reforms. New Delhi: AIIMS, 1995.

[These two books are mainly the collective contribution by the Indian Consortium of Medical Colleges (AIIMS, New Delhi, JIPMER Pondicherry, CMC Vellore and IMS-BHU, Varanasi, in collaboration with the Dept of Medical Education, University of Illinois, Chicago, USA)  under a WHO Project “Inquiry-driven Strategies for innovations in Medical Education”  (1989 – 1995). Hard copy is  available for display only at CMET, AIIMS. For pdf request contact Dr KK Deepak, Prof in-charge, KL Wig CMET, AIIMS, kkdeepak@gmail.com or Mr Yogesh Kumar yogesh.anju@gmail.com ]

• Khosla PK, Angra SK, Talwar D. (eds.) Community Ophthalmology – An Indian Perspective, New Delhi: Current Scientific Literature, 1992

• Khosla PK, Garg SP, Talwar D. (eds.) Assessment Strategies in Ophthalmology. New Delhi : Ideal Impression, 1993

• Sethuraman K.R, Objective Structured Clinical Examination, Jaypee Brothers, New Delhi, 1993

• Sharma SD, Kacker SK, Adkoli BV   In: Sajid AW, Mc Guire CH et al (eds).  International Handbook of Medical Education. Westport, Connecticut. London: Greenwood Press, 1994, pp207-230. [Though this is a book chapter, this is a position paper, useful for in tracing  early development of  medical education in India. ]

• Rita Sood et al (eds). Assessment in Medical Education –Trends and Tools, L.Wig Centre for Medical Education and Technology, All India Institute of Medical Sciences, New Delhi, 1995. [This is very good primer to understand basic concepts in assessment.  pdf version available: Contact person Dr Rita Sood ritasood@gmail.com ]

• Srinivasa D.K., Ananthakrishnan N, Sethuraman K.R, Santosh Kumar. (eds.) Medical Education: Principles & Practice, (Revised Edition), National Teacher Training Centre, Jawaharlal Institute of Medical Education and Research, (JIPMER), Pondicherry, First edition 1995. Revised edition is available.
• Ananthakrishnan N, Sethuraman K.R, Santosh Kumar. (eds.) Medical Education: Principles & Practice , Volume II –Trainers’ Manual, National Teacher Training Centre, Jawaharlal Institute of Medical Education and Research, (JIPMER), Pondicherry, 1997 [Sr No. 8 and 9 are excellent compendium of content of the NTTC Courses conducted by  NTTC, JIPMER Pondicherry]

• Sethuraman K.R. (ed) Developing Clinical Skills – Proceedings of a Workshop. JIPMER, Pondicherry, 1995 [ A useful collection of clinical skills categorized systematically]
• Bali R.K. (ed) Faculty Resource Development for Dental Education in Health Sciences, Asian Pacific Dental Federation: Commission on Dental Education, 1997 [This is useful book for dental profession educators]
• Sethuraman K.R. Trick or Treat. The Society of EQUIP, Pondicherry, 2000 [Interesting reading on medical ethics]
• Sood R. (ed) Postgraduate Training – Key Issues, Indian College of Physicians, Academic Wing of Association of Physicians of India, New Delhi, 2002 [Recommended for PG Teachers]

• Shekar K.S., Srinivas D.K. (eds.) What is not taught in Medical Colleges! Rajiv Gandhi University of Health Sciences, Bangalore.2011 Contact person: rguhsjps@gmail.com [A must read book for all those interested in a holistic approach to medical education]

• Singh T., Anshu (eds.) Principles of Assessment in Medical Education 2012 New Delhi Jaypee Brothers Medical Publishers (P) Ltd. [Excellent resource for assessment in medical education]

• Singh T., Gupta P., Singh D.(eds.) Principles of Medical Education, Fourth edition IAP National Publication House, Gwalior, JAYPEE Brothers, 2013 [Excellent primer in medical education, reads well]

• Bhuiyan P.S.,Rege N.N., Supe A.N. (eds) The Art of teaching medical students. 2nd 2002. Medical Education Technology Cell, Seth G.S. Medical College & K.E. M. Hospital, Parel, Mumbai. [Latest edition of this book is expected soon. Contact person: Dr Pritha Bhuiyan, drprithabhuiyan@yahoo.com ]

Useful materials for Behavior Change Communication (BCC) / Information Education and Communication (IEC)

                                                                                                                           

What is IEC?

Information, Education and Communication (IEC) in health programmes aims to increase awareness, change attitudes and bring about a change in specific behaviours – effectively utilised for creating awareness about Homeopathy among the public.

IEC means sharing information and ideas in a way that is culturally sensitive and acceptable to the community, using appropriate channels, messages and methods. It is therefore broader than developing health education materials, because it includes the process of communication and building social networks for communicating information.

IEC interventions should involve the active participation of the target audience and adopt channels, methods and techniques that are familiar to their world view.

Health information can be communicated through many channels to increase awareness and assess the knowledge of different populations about various issues, products and behaviours.

Channels might include interpersonal communication (such as individual discussions, counselling sessions or group discussions and community meetings and events) or mass media communication (such as radio, television and other forms of one-way communication, such as brochures, leaflets and posters, visual and audio visual presentations and some forms of electronic communication).

Please contribute by sending your materials to Mijjumaniyar@gmail.com

WHO says 57% allopathic doctors in India don’t have true medical degree

                        

A new report from the World Health Organisation (WHO) makes even this poor statistic look worse, given it points out that of the allopathic doctors in the country, more than half (57%) did not have a medical degree. (Reuters)

Also, since AYUSH (Ayurveda, Yoga, Unani, Siddha, Homoeopathy) doctors tend to be better qualified than allopathic ones—according to WHO, 53% of AYUSH doctors had degrees in their respective fields as compared to 43% for allopathic ones– the government would be better off if it were to expand its AYUSH programme.

Published on July 4, the study titled The Health Workforce In India describes the “nature of health workforce inequalities” in the country and provides much needed insight into the many challenges faced by India.

Here are its most important conclusions

1. For a population of 1.02 billion in 2001, there were just 20 lakh health workers in the country. Of these, 39.6% were doctors, 30.5% were nurses and midwives, and a meagre 1.2% dentists.
2. Of all doctors, 77.2% were allopathic and 22.8% were ayurvedic, homeopathic or unani (AYUSH). Other categories of health workers were pharmacists, ancillary health professionals, and traditional and faith healers – they comprised 28.8% of the total health workforce.
3. Shockingly, 31.4% of these allopathic doctors were educated only up to secondary school level and a massive 57.3% did not even have a medical qualification. Among nurses and midwives, 67.1% received education only up to secondary school level.
4. As many as 73 districts in the country had no nurses with a medical qualification.
5. Of all health workers, 59.2% were based in urban areas (home to just 27.8% of the population) and only 40.8% were based in rural areas (home to 72.2% of India’s population.)
6. The education level and medical qualification of urban doctors was much higher than that of rural doctors. While 83.4% of urban allopathic doctors received educated higher than secondary school level, only 45.9% of rural allopathic doctors were as educated.
7. This urban-rural divide was one of the most important highlights of the study. Of the 30 districts with lowest density of allopathic doctors, half were in north-eastern states and the remainder are in central states – including Uttar Pradesh, Bihar and Madhya Pradesh. Of the 30 districts with the highest density of allopathic doctors, more than half were in state capitals including seven in Delhi itself.
8. The case was the same for nurses – their density was at its lowest in districts of Bihar, Uttar Pradesh and Jharkhand and at its best in state capitals or in the national capital. Seven districts of Kerala were among the 30 with highest density of nurses.
9. These gaps sharpened in the area of medical qualifications – while 58.4% urban allopathic doctors were appropriately qualified, only a meagre 18.8% of rural allopathic doctors had a medical qualification.
10. The study also revealed a stark gender divide – of all health workers only 38% were female. The highest number of female health workers was found in Kerala (64.5%) and Meghalaya (64.2%), while states with the lowest female health workers were Uttar Pradesh (19.9%) and Bihar (22.3%).
11. Despite a majority of doctors being male, they were largely less educated than female doctors. Among allopathic doctors, only 37.7% male doctors were medically qualified as compared to 67.2% females.
12. For some states, fraction of AYUSH doctors was much higher than the rest – 41.7% in Tripura, 40.5% in Orissa and 38.1% in Kerala.
13. The study pointed to a general lack of dental healthcare in the country. Of the 593 districts in the country, 58 districts had no dentists at all, while 88 districts had no dentists with more than secondary schooling. 175 districts had no dentists with a medical qualificatio

Colorectal Cancer: What You Should Know

Last year in the United States, more than 136,000 people were diagnosed with—and more than 50,000 died from—colorectal cancer, according to the National Cancer Institute. It is the second leading cause of cancer-related deaths in the United States, striking some groups more often than others. The toll this disease takes on minorities is especially high, said Jonca Bull, M.D., director of FDA’s Office of Minority Health. Populations with limited access to screening and early treatment die much more often from the disease—African Americans, Hispanics, and American Indians and Alaska Natives. But there is a way of confronting this hazard, she added: “Early detection, referral, and treatment can significantly reduce disparities in deaths from colorectal cancer.

Screening saves lives

Colorectal cancer usually starts from polyps or other precancerous growths in the rectum or the colon (large intestine). People with precancerous growths or signs of colorectal cancer don’t always show symptoms. That’s why screening is important—doctors can see and remove growths or suspicious tissue before they become cancerous.

Your risk for colorectal cancer increases if you:

• Smoke
• Have a history of inflammatory bowel disease, ulcerative colitis, or Crohn’s disease
• Have a family history of colorectal cancer
• Have a personal history of colorectal cancer or colon polyps
• Have certain genetic syndromes (for example, Lynch or FAP)
• Have diabetes

You should see your doctor also if you have any of these symptoms, even though they do not necessarily indicate colorectal cancer:

• A change in bowel habits (for example, diarrhea, constipation, feeling that the bowel does not empty all the way)
• Bright or dark blood in stool
• Stools narrower than usual
• Frequent gas pains, bloating, fullness, or cramps
• Weight loss for no known reason
• Feeling very tired
• Vomiting

When and how should I get screened?

You should begin getting screened at age 50 if you are at average risk of developing colorectal cancer. However, some people at higher risk for colon cancer may need to be screened earlier and some may need to undergo more frequent screening. Discuss with your doctor the best strategy for you. Here are several options:

• A colonoscopy— A doctor uses this thin tube with a light and lens to look inside the rectum and colon for growths, other abnormal tissue, or cancer. You will need to prepare for the test and will be sedated during it.
  Routine screening: every 10 years.
• Flexible sigmoidoscopy—A doctor uses a thin tube with a light and lens to look inside the rectum and lower third of the colon for growths, other abnormal areas tissues, or cancer. This thin tube may also include a tool for removing abnormal tissue for examination. You will need to prepare for the test.
  Routine screening: every 5 years.
• Fecal blood test (gFOBTor FIT test)—Using an at-home kit from your physician, you take a sample of your stool and return it to a lab, where it is checked for hidden blood, sometimes a sign of cancer. If blood is found, you will need a colonoscopy to find out why.
  Routine screening: once a year.
• Stool DNA test —Using an at-home kit from your physician, you take a sample of your stool and return it to a lab, where it is checked for blood as well as for genetic changes sometimes found in cancer and precancer cells. If the test is positive, you will need a colonoscopy.
  Routine screening: every 3 years.
• Computed tomography colonography or “virtual colonoscopy”—An X-ray imaging procedure that produces 2D and 3D views of the colon from the rectum to the lower end of the small intestine as well as some visualization of the small bowel. The colon will be gently and temporarily inflated with air through a thin tube tip placed in the rectum. You will need to prepare for the test.
  Routine screening: every 5 years.

Remember to ask your doctor about colorectal cancer screening.

“Regular screening, beginning at age 50, is the key to preventing colorectal cancer,” said Alberto Gutierrez, Ph.D., an FDA expert on screening devices. “People at higher risk of developing colorectal cancer should begin screening at a younger age, and may need to be tested more frequently. Currently, individuals have several options for testing based on their risks and preferences. You should talk with your doctor to determine which screening program is right for you

What’s the good news?

More people who get the disease are surviving or are surviving longer with the help of screening, surgery and/or drugs approved for the treatment of patients with colorectal cancer. Because not all populations react the same way to every treatment, scientists are also developing “companion diagnostics,” tests to determine, for example, if a mutation in a particular gene found in tumors will render a drug effective, ineffective, or even harmful among certain groups.

Researchers study new ways to prevent, treat, and manage the disease. Patients who want to know about clinical trials—research studies that involve people—may want to discuss this option with those close to them and with their doctor.

How can I reduce my risk?

A number of factors may put you at risk for colorectal cancer: your age, medical history, race or ethnicity. But you can reduce that risk. Here’s how:

• Exercise regularly and vigorously
• Maintain a healthy diet (high in vegetables and fruits; low in red and processed meats)
• Maintain a healthy weight
• Limit the amount of alcohol you drink
• Don’t smoke and avoid second-hand smoke

Mercury Poisoning Linked to Skin Products

These skin creams manufactured in other countries are among the products found in recent years to contain mercury. Get hi-res images of these productson Flickr.

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Signs and Symptoms of Mercury Poisoning

• irritability
• shyness
• tremors
• changes in vision or hearing
• memory problems
• depression
• numbness and tingling in hands, feet or around mouth

Source: Agency for Toxic Substances and Disease Registry

Federal health officials are warning consumers not to use skin creams, beauty and antiseptic soaps, or lotions that might contain mercury.

The products are marketed as skin lighteners and anti-aging treatments that remove age spots, freckles, blemishes and wrinkles, says Gary Coody, national health fraud coordinator in the Food and Drug Administration’s Office of Regulatory Affairs. Adolescents also may use these products as acne treatments, adds Coody. Products with this toxic metal have been found in at least seven states.

The products are manufactured abroad and sold illegally in the United States—often in shops in Latino, Asian, African or Middle Eastern neighborhoods and online. Consumers may also have bought them in another country and brought them back to the U.S. for personal use.

“If you have a product that matches these descriptions (and others listed below), stop using it immediately,” says Coody.

“Even though these products are promoted as cosmetics, they also may be unapproved new drugs under the law,” says Linda Katz, M.D., director of FDA’s Office of Cosmetics and Colors. FDA does not allow mercury in drugs or in cosmetics, except under very specific conditions, which these products do not meet.

“Sellers and distributors should not market these illegal products and may be subject to enforcement action, which could include seizure of the products and other legal sanctions,” says attorney Brad Pace, J.D., of the Heath Fraud and Consumer Outreach Branch within FDA’s Center for Drug Evaluation and Research

Dangers of Mercury

“Exposure to mercury can have serious health consequences,” says Charles Lee, M.D., a senior medical advisor at FDA. “It can damage the kidneys and the nervous system, and interfere with the development of the brain in unborn children and very young children.”

You don’t have to use the product yourself to be affected, says FDA toxicologist Mike Bolger, Ph.D. “People—particularly children—can get mercury in their bodies from breathing in mercury vapors if a member of the household uses a skin cream containing mercury.” Infants and small children can ingest mercury if they touch their parents who have used these products, get cream on their hands and then put their hands and fingers into their mouth, which they are prone to do, adds Bolger.

How to Protect Yourself

• Check the label of any skin lightening, anti-aging or other skin product you use. If you see the words “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or “mercury,” stop using the product immediately.
• If there is no label or no ingredients are listed, do not use the product. Federal law requires that ingredients be listed on the label of any cosmetic or drug.
• Don’t use products labeled in languages other than English unless English labeling is also provided.
• If you suspect you have been using a product with mercury, stop using it immediately. Thoroughly wash your hands and any other parts of your body that have come in contact with the product. Contact your health care professional or a medical care clinic for advice.
• If you have questions, call your health care professional or the Poison Center  at 1-800-222-1222; it is open 24 hours a day.
• Before throwing out a product that may contain mercury, seal it in a plastic bag or leak-proof container. Check with your local environmental, health or solid waste agency for disposal instructions. Some communities have special collections or other options for disposing of household hazardous waste

Tracking Skin Products Containing Mercury

Investigations in the past few years by FDA and state health officials have turned up more than 35 products that contain unacceptable levels of mercury. FDA continues to add mercury-containing skin products to its import alerts, which authorize the agency’s field staff to refuse admission of shipments of these products.

But this is only a partial solution, says Coody. “Many of these products are coming into the country through channels we can’t easily track, such as international mail and personal baggage. That’s why it’s so important for consumers and sellers to know about the dangers of possible mercury poisoning associated with the use of these skin products.”

Texas health officials say samples of face cream they tested contained mercury up to 131,000 times the allowable level. And a teenager in southern Texas who used a mercury-containing skin cream was recently hospitalized for mercury poisoning.

In Northern California, a 39-year old woman had more than 100 times the average amount of mercury in her urine and had symptoms of mercury poisoning, according to the California Department of Public Health. For three years, the woman and her husband had been using an unlabeled mercury-containing face cream that was brought into the U.S. from Mexico by a relative. Several other family members who did not use the cream, including a four-year-old child, also had elevated levels of mercury in their bodies.

Virginia, Maryland, and New York have also seen cases of elevated mercury levels in people exposed to skin products containing mercury. In Minnesota, 11 of 27 imported skin products taken from store shelves contained mercury . Photos of some illegal mercury-containing products are shown here