Although the Food and Drug Administration FDA approved labeling for the antihistamine, promethazine, already contained a warning about the risk of serious breathing problems when the drug is used by children, a number of deaths in children under two years of age has prompted Emergency Alerts to both healthcare professionals and consumers to advise of a label change that contains “strengthened warnings.”

The Alert released as part of the Patient Information Sheet states that:

“Medications containing promethazine hydrochloride (HCl) should not be used for children less than two years old because of possible breathing problems.  This includes promethazine HCl in any form: syrups, suppositories, tablets, or injectables.  Cases of breathing problems, some causing death, have been reported to the FDA when the drug was used in children less than two years old.”
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By Steven DiJoseph

Taser stun guns have been at the center of an ongoing controversy for years with respect to their safety as “non-lethal” weapons. The debate has developed along two distinct lines, however.

The first is whether Tasers, even when used as instructed, are potentially deadly because of a number of pre-existing conditions suffered by many individuals or due to the location at which the shocking device attaches itself to a suspect in some situations.
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The Consumer Product Safety Commission (CPSC), in cooperation with two manufacturers, has announced voluntary recalls of the two similar backpack-type blowers that pose fir and burn riskds to users. Consumers should stop using the recalled products immediately.

RedMax Gas-Powered Backpack Blowers – These blowers (about 170,000) were manufactured in Japan and Georgia (U.S.) and imported by Komatsu Zenoah America, doing business as RedMax, of Norcross, Georgia.
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In a little over a month, Philip Morris has been handed two stunning losses on appeals involving punitive damage awards in California totaling $78 million.

Only last month, the U.S. Supreme Court has denied the Petition for  a Writ of Certiorari on behalf of tobacco giant Philip Morris USA Inc. from a final disposition of the Court of Appeal of California, Second Appellate District.

In that case, brought by a man (Richard Boeken) who died of cancer in 2002, there had originally been a $3 billion punitive damage award in 2001 that was based on a jury finding that Philip Morris was liable for negligence, misrepresentation, fraud, and the sale of a defective product.
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The Food and Drug Administration (FDA) has announced the approval of the first generic version of Bristol-Myers Squibb’s Pravachol (Pravastatin Sodium Tablets), which the agency sees as “an important step in the agency’s effort to increase the availability of lower-cost generic medications.”

Pravastatin is indicated for “the treatment of individuals with high cholesterol levels (hyperlipidemia) or who are at increased risk for atherosclerosis-related cardiac and cardiovascular events, such as heart attack and stroke in which high cholesterol levels are a factor.”
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According to a new study published in the latest issue of Circulation, Journal of the American Heart Association, even massive amounts of coffee consumed on a daily basis over many years does not increase the risk of developing coronary heart disease.

The study even found that people who drank six or more cups of coffee on a daily basis for up to two decades had a slightly lower risk of developing coronary artery disease than those who drank a cup or less each day.
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By Steven DiJoseph

Although there is no doubt that every drug has at least one side-effect, there is no way to ascertain just how many people are affected in an adverse way by any particular. To be sure, not every side-effect is life-threatening and many are relatively mild; however, since each person reacts differently to a given drug, there may be wide variances in the scope and severity of reactions.

Clinical tests are usually of limited value in this area for three reasons (at least):
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By Steven DiJoseph

For years, critics of the FDA have claimed that suffers from a number of serious operational problems that have caused it to become an ineffective guardian of the public’s wellbeing and little more than a rubberstamp for the multi-billion-dollar pharmaceutical industry.

Those who have raised their voices against what they perceive as a bloated regulatory agency rife with mismanagement, internal strife, and conflicts of interest include members of Congress, highly-respected scientists and medical experts, FDA whistleblowers, and consumer advocacy groups.

Thus, when the Government Accountability Office (GAO) was asked by Congress to examine the FDA (following the debacle surrounding the withdrawal of the COX-2 inhibitor Vioxx); few expected anything but a laundry list of criticisms. The GAO did not disappoint. In fact, its report exceeded expectations for candor.
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By Steven DiJoseph

From every indication, the current outbreak of serious fungal eye infections is going to get worse before it gets better and that is not good news for the public and certainly not an encouraging sign for Bausch & Lomb.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are anxiously searching for the source of the problem while the number of reported cases of the normally rare infection continues to increase dramatically.

Both the CDC and the FDA are continuing their examination of data from their inspection of Bausch & Lomb’s Greenville, South Carolina plant where ReNu With MoistureLoc contact lens solution if manufactured. Those agencies have stated that their analysis could take another month, however.
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By Steven DiJoseph

The ghoulish tale of stolen body parts, missing persons, diseased human tissue grafts, and the possibility that thousands of innocent patients are now at risk of developing everything from HIV/AIDS and syphilis to hepatitis B and C has become a scandal of nationwide proportions that has health officials in several states as well as the FDA and CDC extremely concerned.

Reports are now appearing that almost 100 more patients (this time in the Atlanta area) have been informed that human tissue grafts they received may have been from diseased body parts that were stolen from corpses in funeral homes and never properly screened for a wide range of serious and even life-threatening infectious diseases.
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