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Pharmaceutical Products
Also, Robbins Associates, P.C., Atlanta Georgia personal injury attorneys, represents individuals who have been harmed as a result of taking the drug Rezulin for the treatment of type 2 diabetes. On March 22, 2000, the manufacturer voluntarily removed this drug from the market after the Federal Drug Administration determined that it was too dangerous for use.
Drug stores move to remove cold, diet drugs after FDA warning. November 7, 2000 Web posted at: 5:00 AM EST (1000 GMT) "We would advise our customers to check with
the pharmacist about the alternatives," she said. Dieters will need to consult doctors Over-the-counter alternatives do not exist for diet pills, however, so dieters will have to consult doctors about prescription-only alternatives, Ganley said. Whitehall-Robins Healthcare quit shipping PPA-containing Dimetapp on Monday. New liquid Dimetapp formulas lacking PPA will head for store shelves next week, with pill versions to follow. Also, some stores are selling PPA-containing versions of its Robitussin-CF product, and some are selling a new non-PPA formula, in boxes flagged with a yellow band. SmithKline Beecham Consumer Healthcare said people should not use its PPA-containing Contac 12-hour Cold Capsules, but five other Contac versions contain the safe pseudoephedrine. Risk is small, effects can be deadly Top-selling manufacturers that refused to reveal their plans include Novartis Corp., maker of PPA-containing Triaminic and Tavist-D; Bayer Corp., maker of Alka-Seltzer Plus cold medicines; and Chattem Inc., maker of Dexatrim diet pills. About 6 billion doses of PPA are sold in this country each year, mostly without prescriptions. There are a few PPA-containing prescription decongestants, and the FDA asked their makers also to stop selling them while it moves to ban prescription use as well. While the risk of a hemorrhagic stroke, or bleeding
in the brain, is very small to an individual user, these are often
deadly strokes, and survivors can be left disabled. Hemorrhagic strokes typically occur in the elderly, and are extremely rare under age 50. In the 1980s, however, medical journals cited several dozen young women who suddenly had strokes days after taking their first PPA-containing diet pill. A five-year Yale University study comparing PPA use among stroke survivors with healthy people concluded that PPA increases stroke risk for young women within three days of taking PPA-containing appetite suppressants, or within three days of taking their first-ever PPA dose for any reason. In some cases, using PPA increased stroke risk 12- to 15-fold. Nobody knows why, although first-time PPA use sometimes temporarily raises blood pressure, an effect that wanes as the body gets used to the drug. Risk was highest with the higher doses -- more than 75 milligrams daily -- that dieters typically used. The study didn't find men at risk, but the FDA cautioned
that enough men weren't studied to be sure they're OK. Cold or Diet Pills That Contain Phenylpropanolamine (PPA) The FDA has warned all Americans that they should not take cold or diet pills that contain phenylpropanolamine (PPA). PPA has been linked to a higher risk of hemorrhagic stroke among young women. The FDA also asked manufacturers to stop selling drugs that contain PPA and to replace it with a safer ingredient. Many drug stores began pulling products containing PPA from the shelves and have posted warnings about the potential dangers. The FDA is considering adding warning labels to Celebrex indicating that it may be linked to an increased risk for heart attacks. This news comes after a study showed that patients taking a similar drug called Vioxx ran four times the risk for heart attack as those taking regular pain relievers such as ibuprofen. Because both drugs are COX-2 inhibitors, the FDA would apply labels to both medications. May 25 — Ever since Celebrex and Vioxx hit the
market in 1999, consumers have been bombarded with television ads
depicting the benefits of the new arthritis drugs. Celebrex commercials
showed joyful arthritis sufferers practicing tai chi, strolling
the beach and zipping along scenic roads on tandem bicycles to the
tune of “Celebrate.” Vioxx ads had similar themes, featuring
arthritis patients pushing wheelbarrows, hammering nails and generally
living it up. No studies have been released on the heart risks associated specifically with Celebrex. Is it safe to assume that the risks posed by Vioxx are similar to those posed by Celebrex, since they’re both in the same drug category? German drug manufacturer Bayer AG pulled their popular cholesterol lowering drug, Baycol from the market. Baycol was withdrawn from the market because it has been linked to 31 US deaths from a muscle-related side effect, according to the US Food and Drug Administration. Baycol is one of an extraordinarily popular family of cholesterol-lowering drugs called "statins." Baycol was approved in the United States by the FDA in 1997. The FDA had received reports of Baycol patients experiencing severe rhabdomyolysis. Rhabdomyolysis is a condition that causes muscle-cell breakdown (atrophy) and causes muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea and vomiting. In a Reuters article the FDA claimed that in some
cases, rhabdomyolysis is so severe that patients develop failure
of the kidney or other organs, which can be fatal. "While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins,'' the FDA said. Baycol patients who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician, the FDA said. Others taking Baycol should talk to their doctors about switching to alternative medications, the agency advised. The popular and heavily advertised arthritis drugs Vioxx and Celebrex have been linked by researchers to an increase in the risk of blood, clots, heart attacks and strokes. The study from the Cleveland Clinic appeared in the Journal of the American Medical Association and was based on an analysis of previous clinical trials. Celebrex and Vioxx are projected to produce U.S. sales greater than $6 billion this year. In a study of more than 8,000 patients that compared the COX-2 inhibitor rofecoxib (Vioxx) with the traditional NSAID naproxen, the risk of cardiovascular problems, including heart attack, chest pain related to heart disease, stroke, sudden death and blood clots, was more than two times higher in the rofecoxib group than in the naproxen group. Vioxx and Celebrex are classified as and known as COX-2 inhibitors, or coxibs. COX-2 inhibitors, like older drugs such as ibuprofen and naproxen, are nonsteroidal anti-inflammatory drugs, or NSAIDs. Older NSAIDs reduce inflammation by blocking an enzyme called COX-2, but they also block another enzyme called COX-1. This enzyme helps protect the lining of the stomach, so blocking COX-1 can cause stomach irritation. COX-2 inhibitors only block COX-2, leaving the stomach-protecting COX-1 alone. The annual rates of heart attack in both the Celebrex (celecoxib) and Vioxx (rofecoxib) studies were increased compared to a review of studies containing a total of more than 48,000 patients. In those studies, 0.52% of patients taking an inactive placebo pill had a heart attack each year. The annual rate of heart attack was 0.74% for patients taking rofecoxib and 0.80% for those taking celecoxib. The researches believe that until more research is done, doctors should use caution in prescribing Vioxx and Celebrex to patients with heart disease. Rezulin Special Update On March 21, 2000 head of the FDA's center for Drug evaluation and Research stated that the "Continued use of Rezulin" posed an "unacceptable risk " to diabetes patients. At least 63 Rezulin users have died of liver failure. The total number of Rezulin related deaths is estimated to be as many as ten times higher than the reported 63 cases. For this reason, Rezulin was removed from the United States market. Doctors prescribed Rezulin to diabetics who took insulin but whose blood sugar was not well controlled. Rezulin was designed to help insulin (either your own or injected) work better, by drawing the sugar from your blood into the cells to supply energy. Rezulin was approved for diabetics who:
Rezulin was banned in England in December 1997, following the death of an American who took the drug. The drug manufacturer, Warner-Lambert successfully fought a ban on Rezulin in the U.S. for 27 months before the FDA decided to prohibit sales of Rezulin on March 21, 2000. Since this date hundreds of Rezulin related lawsuits have been filed. Before the ban, sales of Rezulin
generated Warner-Lambert $1.8 billion in revenues. At its peak,
the drug was prescribed 488,000 times in January of 1999. 63 Rezulin
users have reportedly died from use of the drug. The deaths were
caused by liver failure. The total number of deaths associated with
Rezulin is likely to exceed 63 by many times according
to experts. In September 1997, the FDA requested the recall of fenfluramine (Pondimin) and dexfenfluramine (Redux), two drugs taken with phentermine to produce a weight loss “drug cocktail.” Increasing evidence that fen-phen caused heart valve defects led the FDA to order the recall. Read the FDA press release below. Thimerosal (Mercury Poisoning from Vaccines) Thimerosal is the most common preservative that is used in vaccines and biologics that are marketed in the United States. Thimerosal is used to help prevent a vaccine from spoiling, for inactivating bacteria used to formulate several vaccines, and in preventing bacterial contamination of the final product. Several of the vaccines recommended routinely for children in the United States contain thimerosal. However, reports have surfaced linking thimerosal to mercury poisoning in infants often causing autism. On July 7, 1999, the American Academy of Pediatrics (AAP) issued with the US Public Health Service (USPHS) a joint statement alerting clinicians and the public of concern about thimerosal, a mercury-containing preservative used in some vaccines. The reason for the warning is that thimerosal contains a related mercury compound called ethyl mercury. Mercury is a toxic metal that can cause immune, sensory, neurological, motor, and behavioral dysfunctions. The Food and Drug Administration suggested that some infants, depending on which vaccines they receive and the timing of those vaccines, may be exposed to levels of ethyl mercury that could build up to exceed one of the federal guidelines established for the intake of methyl mercury. Symptoms of mercury toxicity in young children are extremely similar to those of autism. This can explain the recent increase in the numbers of children diagnosed with autism since the early 1990's. The numerous amount of children diagnosed with autism seems to directly correlate with the recommendation of both the hepatitis B and HIB vaccine to infants in the early 1990s. Autism is a neurological disorder that is characterized by impairments in language, cognitive and social development. Autism symptoms are usually encountered in the first two years of life. In the past autism was considered a rare disorder with an incidence of occurrence of approximately 1-3 per 10,000 births. More recently however, Autism is being diagnosed much more frequently with an incidence of occurrence of 20-40 per 10,000 births and reports of 1 per 150 births have been reported in several states including New Jersey and California. SEE OUR FREE CASE EVALUATION FORM
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Frequently,
drugs and medicines are at the center of toxic tort suits. The manufacturer
of a drug may be liable to a plaintiff if the drug proves to be
defective. 