Parents Miss Warning On Toddlers’ Cold Medicine

Angel Reyes III Dangerous Behavior, Dangerous Drugs

sick-child-200x299According to last month’s poll by researches at the University of Michigan, 42% of parents gave over-the-counter cough and cold medications to their children under the age of 4. Additionally, 44% gave them multi-symptom cough and cold medications. And 25% gave these toddlers decongestants. The survey comes a whopping five years after these drugs’ packages included warnings against using them in very young children.

In 2008, the Food and Drug Administration advised that these medications not be given to children under the age of 2. The previous year, an agency advisory committee had determined that children younger than 6 shouldn’t take these medications. It was even suggested that these medications didn’t help young children. The FDA said that some of the drugs might be associated with side effects and some deaths in very young patients, primarily due to overdoses.

Manufacturers followed the FDA’s advice and put warnings on their products’ boxes saying they shouldn’t be given to children under the age of four. Medications containing these warnings contain dextromethorphan, a cough suppressant, gauifenesin, an expectorant and the decongestants phenylephrine and pseudoephedrine. Medications with antihistamines warn against use in children younger than six. Major brand names of these medications include Novartis, Pfizer, Triaminic, Dimetapp and Robitussin.

The Consumer Healthcare Products Association represents makers of these over-the-counter medications. It said most cases of side effects involve children taking the meds without parental supervision. It went on to say that the drug facts panel should remain on the back of the packaging rather than the front. But of course, putting the warning on the front might mean parents would actually READ it.

In spite of these and other so-called efforts to alert parents, a study in 2010 published in the journal Child: Care, Health and Development found that about 1/3 of parents had never heard of the FDA’s recommendations. Of those who had, 1/3 planned to continue giving these meds to their children. A 2011 poll from the University of Michigan showed that 61% of parents with children 2 and younger had given them cough and cold medications. And yet another study recently published in Clinical Pediatrics found that 82% of 65 parents of children younger than 6 said they would use the medications. Almost 3/4 of those parents said they would administer the wrong dose. In fact, some parents read the instructions and just made up their own dose. So the misuse of these medications is not just the fault of the manufacturers, but some parents as well. Apparently parents become frustrated because there are not enough medications out there to help their young children, and out of desperation, use the medications designed for older children.

Zolpidem (Ambien) ER Visits On The Rise

Angel Reyes III Dangerous Drugs, In The News

ambienZolpidem is a prescription sleep medication that is sending more and more people to emergency rooms from its serious side effects. Never heard of Zolpidem? Well, I bet you’ve heard of Ambien. Zolpidem is the active ingredient in Ambien, Ambien CR, Edluar and Zolpimist. But the most common among these is Ambien.

I’ve heard countless stories of people doing some pretty crazy things on Ambien – like sleepwalking into a 7-11 while in their pajamas. I’ve also heard some horrific stories about terrible nightmares and hallucinations from taking Ambien.

According to a new federal report by the Substance Abuse and Mental Health Services Administration’s Drug Abuse Action Network (DAWN), from 2005-2010, visits to emergency rooms from the adverse side effects of Zolpidem increased by over 200 percent. The findings of this report are as follows:

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  • In 2010, there were 64,175 emergency-department visits involving zolpidem. Of these, 19,487 — or 30 percent — specifically involved adverse reactions to the sleep medication.
  • In 2005, there were just 6,111 emergency-room visits involving adverse reactions to the sleep drug. During the period 2005-2010, emergency-department visits involving adverse reactions to zolpidem rose almost 220 percent.
  • Women accounted for 68 percent of emergency-department visits related to adverse reactions to zolpidem in 2010. The differences between men and women fluctuated during the five-year period, but overall women made up a greater number of the zolpidem-related emergency visits in every year but 2008.
  • The number of emergency room visits made by women involving adverse effects of zolpidem increased by 274 percent from 2005-2010. Visits by men increased 144 percent.
  • Adults ages 45 and older accounted for 74 percent of all emergency room visits involving adverse reactions to zolpidem.
  • Patients ages 65 and older were the most common age group to seek emergency treatment for adverse reactions to zolpidem – 32 percent.
  • Patients ages 45-54 were the next largest group, accounting for 22 percent of all visits.
  • Of the total visits to emergency room visits related to adverse effects of zolpidem, 40 percent involved the sleep drug alone.
  • In 50 percent of the cases, one or more additional prescription drugs were involved.
  • The most common prescription drugs seen in combination with zolpidem’s adverse effects included narcotic pain relievers, antidepressants, anti-anxiety medications and other insomnia medications.
  • Research also has shown that older adults are at greater risk for adverse effects from sleep medications, including those containing zolpidem.

In January of this year, the Food and Drug Administration issued a Zolpidem safety alert and announced it would require drug makers to cut in half the recommended dosages of medications containing zolpidem for women. The agency also recommended lowering the dosages for men, and urged medical professionals to warn all patients taking zolpidem about potential side effects. Sleep medications that contain zolpidem should be prescribed on a short-term basis only in severe cases of sleep disorders.

Big Pharma has once again created a monster with medications containing zolpidem. And as usual, rather than treating the problem, American doctors prescribe these pills to alleviate the symptoms.

Drug Research Company Caught Red-Handed. Now What?

Angel Reyes III Dangerous Drugs

drugs-blog-post-april20131-300x199Cetero Research, a Houston-based firm that researched safety and effectiveness for drug companies throughout the world got busted.  On May 3, 2010, agents from the FDA (Food and Drug Administration) visited the firm to investigate a former employee’s claim that the company fraudulently manipulated records and test data. The lead agent, Patrick Stone, explained the severity of the situation to Cetero’s president, Chinna Pamidi, who admitted to Stone that the allegations were correct.  According to Stone, Pamidi literally said, “You got us.”

File boxes containting five years of data from approximately 1,400 drug trials were evaluated. Based on these records and other tell-tale evidence, the FDA announced that the lab’s violations were so blatantly “egragious” and of a “pervasive nature,” the research conducted between April 2005 and August 2009 was most likely worthless.

So what does this mean to consumers?  It means that around 100 drugs, including chemotherapy compounds and addictive prescription painkillers were approved for sale in this country based partly on Cetero’s fraudulent tests.  Most of these drugs were generics of name-brand drugs.  Astoundingly, Cetero scientists had not even run tests on whether the ingredients in the generics were the same as the originals.  These drug tests included ones for seemingly harmless generics such as ibuprofen gelatin capsules, which were sold by one of the country’s largest grocery store chains for months before the FDA was assured they were safe.

Agent Stone expected the FDA to rapidly alert patients and doctors. However, in its usual fashion, the agency was not only slow to act, it didn’t publicly announce anything. Instead, it quietly “handled” the matter. No drugs were pulled off the market.  What’s more amazing is that even now, some of these drugs are still on the market even though the FDA has absolutely no idea of their safety or effectiveness.

But wait, there’s more!  On two separate occasions, the FDA announced it was making drug makers reanalyze, repeat or audit Cetero’s research.  They even gave them deadlines to report their findings back to the agency.  However, both times, the agency allowed some of these manufacturers to extend their deadlines, while other companies simply removed their drugs from the market.

It is now April 2013 – three years after the initial “drug bust,” (so to speak).  The FDA has finished reviewing only 21 of the 53 submissions.  This means that many consumers of over-the-counter drugs or patients prescribed more serious drugs are taking them to this very day.

Believe it or not, the FDA is refusing to disclose the names of the drugs it’s evaluating, claiming that in doing so, it would expose “confidential commercial information.  The agency defended its handling of the situation.  In fact, Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, said “It is non-trivial to have to redo all this, to withdraw drugs, to alarm the public and the providers for a large range of drugs.  “There are consequences. To repeat the studies requires human experimentation, and that is not totally without risk.”  She also said that the potential for harm from drugs tested by Cetera was “quite low” as confirmed by the fact that there were no problems with drugs the agency had reviewed.  (Remember, the number of drugs reviewed was less than half of those submitted.)

Woodcock added that an agency risk assessment found the potential for harm from drugs tested by Cetero to be “quite low,” as “confirmed” by the fact that no problems have been found in the drugs the agency has finished reviewing.

Many experts say the FDA is refusing to meet its public obligations by not disclosing its findings of the 21 completed reviews.  David Kessler, who headed the FDA from 1990 to 1997 and is now a professor at the University of California said,  “If there are problems with the scientific studies, as there have been in this case, then the FDA’s review of those problems needs to be transparent.  FDA may be right here, but if it wants public confidence, they should be transparent. Otherwise it’s just a black box.”

So what does Stone, the former FDA investigator have to say?  “They could have done more.  They should have done more.”  That’s an understatement, to say the least.  He also said that there are thousands of bioequivalence studies done each year, each generating thousands of pages of paper records.  According to Stone, “Do you really think we’re going to look at 100 percent of them? We’re going to look at maybe 5 percent if we’re lucky.  Sometimes 1 percent.”  I admire his candor, but am abhorred by this and so many other blatant mishaps involving dangerous drugs and medical devices by the FDA.  Is it incompetence or is the FDA in bed with the drug companies?  That’s another story.  All I know is that it’s time for some real changes to how Big Pharma and the FDA conduct their business.