Solar Biomedical Blog

Parents of infants may not have heard the FDA warnings about cough and cold products in young children less than 2 years of age issued after the 2007 findings of harm and death to infants (less than 2 years of age) who used these products.  In January 2008, manufacturers voluntarily removed over-the-counter (OTC) infant cold and cough products from the market due to safety concerns.  Later in fall of 2008, manufactures also voluntarily re-labeled these cough and cold products to state: “do not use in children under 4 years of age.”  However, there remains a concern that many parents may still be giving cough and cold products to their infants that are clearly labeled and designed for older children.  Since infant formulations of cough and cold products were voluntarily removed from the market years ago, parents who currently give these products to their infants (less than 2 years of age) may be using cough and cold products designed for older children and modifying the doses, for instance by giving half the recommended amount to the infant than what is recommended for an older child.  This can be especially dangerous as dosing adjustments cannot safely be made this way and could add to the existing risk of giving these products to young children.

 The FDA reminds all caregivers never to give a child under two years of age any kind of cough and cold product containing decongestants or antihistamines, without seeking the advice of a healthcare provider.  These cough and cold products include those that contain the decongestants ephedrine, pseudoephedrine, or phenylephrine, and the antihistamines diphenhydramine, brompheniramine, or chlorpheniramine.

 Alternatives to cough and cold medicines for infants:

 Well-informed physicians can offer parents a variety of alternative treatments for infants to help with cough and cold symptoms.  For instance, here are some commonly used recommendations:

•  A cool mist humidifier helps nasal passages shrink and allow easier breathing (do not use warm mist humidifiers as they can cause nasal passages to swell and make breathing more difficult);
• Saline nose drops or spray keep nasal passages moist and helps avoid stuffiness;
• Nasal suctioning with a bulb syringe either with or without saline nose drops, works especially well for infants less than a year old. Older children often resist its use;
• Acetaminophen or ibuprofen can be used to reduce fever, aches and pains. Parents should carefully read and follow the product’s instructions for use label;
• Drinking plenty of liquids will help the child stay well hydrated.

For more information, visit  www.fda.gov.  If you found this article helpful, please let us know with your comments.

 Many clinical research professionals such as data managers, biostatisticians, study coordinators, medical monitors, project managers, regulatory specialists, etc. often do not get a chance to meet face to face with the people they correspond with on a daily or weekly basis due to the nature of their jobs.   They usually exchange important clinical trial information via telephone or by e-mail with individuals who are conducting or monitoring the clinical trial on the front end like the investigators and clinical research associate (CRA).

 Fortunately,  with the advent of Facebook, much of this is a thing of the past.  Clinical research professionals are logging onto facebook to get a glimpse of who the person is on the other end of the conversation or e-mail.  Is this a smart business decision or is it an infringement of privacy?  We would love to hear you comments on this one.

In 2010, The Food and Drug Administration (FDA) approved many generic drugs that treat a wide variety of conditions and help consumers save money.  Significant FDA approvals of generic drugs are listed below:

• Anastrozole Tablets (1 mg)
  Used for treating early breast cancer in women who have been through menopause. Also used (in women who have been through menopause) as a first treatment of breast cancer that has spread within the breast or to other areas of the body.
• Venlafaxine Hydrochloride extended-release capsules(37.5mg, 75mg, and 150mg)
  Used for treating Major Depressive Disorder (MDD).
• Aztreonam (for Injection)
  Used for treating a wide variety of bacterial infections. It is an antibiotic that stops the growth of bacteria.
• Enoxaparin Sodium Injection
  Used for multiple purposes, including prevention of deep vein thrombosis, a potentially deadly condition that occurs when a blood clot forms in one of the body’s deep veins, usually in the legs.
• Losartan Potassium Tablets (25 mg, 50 mg, and 100 mg)
  Used to help control high blood pressure, which is also known as hypertension. It is also used to lower the risk of stroke in people who have high blood pressure and a heart condition called left ventricular hypertrophy (enlargement of the walls of the left side of the heart).

On December 29, 2009, the FDA issued a proposal to amend 21 CFR 50.25, its regulation for informed consents.  The new mandate requires that the informed consent documents for applicable drug and device clinical trials include a statement that applicable clinical trial information
has been or will be submitted to the National Institutes of Health/National Library of Medicine
(NIH/NLM) for inclusion in the statutorily required clinical trial databank,www.ClinicalTrials.gov.   This rule is  effective on March 7, 2011.    The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or  after the compliance date.

The need for this rule arises from section 801(b)(3)(A) of the Food and Drug Administration Amendments Act of 2007 (FDAAA) which promotes transparency of clinical
research to participants and patients.  It requires that the current regulations for
informed consent documents and process be changed to include a  statement that clinical trial information from the clinical investigation has been or will be submitted to www.clinicaltrials.gov.
The FDA has made the decision that revising the general informed consent section is the
appropriate step by which to fulfill the requirements of the statute, and will give the pertinent information and protection for clinical trial participants.

Several objections were made to the inclusion of this informed consent statement for various reasons. Some reviewers believed the statement  would cause confusion or anxiety to the participants.
Others believed the statement would distract the participants from focusing on the substantive issues concerning the study that would affect one’s decision to participate in the study. Some commenters insisted that the overall effect of the statement would be a reduced participation rate for prospective participants.

In response to the objections of the new informed consent element, the FDA acknowledges that additional time will be required to read and, if necessary, discuss the statement that
FDAAA mandates be included in the informed consent documents and process. The FDA does not agree, however, that the benefit of the statement to the participant is directly related to the time
it takes to read and discuss the statement. The FDA also has revised the statement to make it shorter and easier to understand by deleting those terms that could be expected to cause anxiety
and confusion. The FDA believes that in doing so it has reduced the theoretical possibility that the statement would cause some participants to abandon the study as much as possible while still
fulfilling the FDAAA mandate.

In 2009, the FDA issued a qualitative explanation of the expected benefits of the proposed rule to
clinical trial participants:

1) The rule would increase the transparency of clinical trials by increasing participant and patient
awareness of the existence of the clinical trials databank (www.clinicaltrials.gov) and those trials
that are registered in the databank;

2) By helping to create a system of checks and balances through which participants,
patients, and health care providers are encouraged to check whether information about a trial of interest is registered in the databank, it would provide greater accountability of clinical
trial investigators for outcomes and adverse events, thereby raising confidence in the validity of the
research process;
3)It would encourage physicians and patients to obtain more information in order to
make more educated treatment decisions.

The FDA has not tried to quantify these benefits, but believes that the overall impact of the rule on public health would be positive.

The cost of incorporating the new rule into the informed consent documents is expected to be very small. The new statement would only need to be written once per protocol and is estimated to take about 5 minutes. The total costs  of the final rule to both industry and the clinical trial
participant population are estimated to range from $3.14 million to $5.46 million annually. This equates to $611 to $1,061 per trial protocol, or about $2.95 to $3.05 per clinical trial participant.

FOR FURTHER INFORMATION CONTACT:
Jarilyn Dupont, Office of Policy, Office
of Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4248, Silver Spring,
MD 20993–0002, 301–796–4830.

References:   Federal Register, / Vol. 76, No. 2 / Tuesday, January 4, 2011 / Rules and Regulations, pp 256 – 270.

With the recent rise of counterfeit medicines being sold on the internet, the FDA offers the following tips how to purchase safe drugs on line:

• Only purchase from state-licensed pharmacy websites that are located in America.
• Don’t buy from websites that don’t require a prescription for the drugs you want to purchase.
• Don’t buy from websites that will prescribe a medicine for the first time without a physical exam by your physician or by answering an online questionnaire.
• Contact your state board of pharmacy or the National Association of Boards of Pharmacy to find out if an online pharmacy has a legal pharmacy license and meets state quality requirements.
• Check for privacy and security policies that are easy to find and understand.
• Do not provide personal information—such as a social security number, credit card information, or medical or health history—unless you feel like the website will keep your information safe and secure.
• Use websites that have a licensed pharmacist to answer your question.
• Read everything on the website to make sure that it will not sell your personal information, unless you agree.

To learn more about protecting yourself against a wide range of bogus health products that includes counterfeit drugs, see FDA’s Consumer Update, “FDA 101: Health Fraud Awareness.”

Counterfeit drugs are fake or copycat products that can be difficult to identify.

The deliberate and fraudulent practice of counterfeiting can apply to both brand name and generic products, where the identity of the source is often mislabeled in a way that suggests it is the authentic approved product.

Counterfeit drugs may

• be contaminated
• not help the condition or disease the medicine is intended to treat
• lead to dangerous side effects
• contain the wrong active ingredient
• be made with the wrong amounts of ingredients
• contain no active ingredients at all or contain too much of an active ingredient
• be packaged in phony packaging that looks legitimate

For example, counterfeit versions of the FDA-approved weight loss drug Xenical, which contains the active ingredient orlistat, recently were obtained by three consumers from two different websites.

Laboratory analysis showed that the capsules that the consumers received contained the wrong active ingredient, sibutramine.

Sibutramine is the active ingredient of a different medicine called Meridia, a prescription drug also approved by FDA to help obese people lose weight and maintain weight loss. In addition, sibutramine is classified as a controlled substance by the Drug Enforcement Administration because of its potential for abuse and misuse.

Using medicine that contains an active ingredient that wasn’t prescribed by your licensed health care provider may be harmful.

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.

For more information on this topic, visit FDA’s Web page on Counterfeit Medicine⁶.

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.

For example, FDA purchased and analyzed several products that were represented online as Tamiflu (oseltamivir). One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets. When analyzed by FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir.

FDA also became aware of a number of people who placed orders over the Internet for one of the following products:

• Ambien (zolpidem tartrate)
• Xanax (alprazolam)
• Lexapro (escitalopram oxalate)
• Ativan (lorazepam)

Instead of receiving the drug they ordered, several customers received products containing what was identified as foreign versions of Haldol (haloperidol), a powerful anti-psychotic drug. As a result, these customers needed emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms, and muscle stiffness—all problems that can occur with haloperidol.

Other websites sell counterfeit drugs that may look exactly like real FDA-approved medicines, but their quality and safety are unknown.

Signs of a trustworthy website

• It’s located in the United States.
• It’s licensed by the state board of pharmacy where the website is operating. A list of these boards is available at the website of the National Association of Boards of Pharmacy.
• It has a licensed pharmacist available to answer your questions.
• It requires a prescription for prescription medicines from your doctor or another health care professional who is licensed to prescribe medicines.
• It provides contact information and allows you to talk to a person if you have problems or questions.

Another way to check on a website is to look for the National Association of Boards of Pharmacy’s (NABP) Verified Internet Pharmacy Practice Sites™ Seal, also known as the VIPPS® Seal.

This seal means that the Internet pharmacy is safe to use because it has met state licensure requirements, as well as other NABP criteria. Visit the VIPPS website to find legitimate pharmacies that carry the VIPPS® seal.

Welcome to the Solar Biomedical Clinical Research blog where we provide frequent  updates on the hot topics in clinical research.