Articles Posted in Unsafe Drugs

What happens when a drug that you have been prescribed by your doctor has been recalled and nobody bothered to tell you?

You’re not alone. It’s a frequent occurrence, one that has a potential quality-of-life altering impact.

Every year dozens of pharmaceutical drugs are recalled because of numerous reasons but adverse side effects and contamination seem to be the most prevalent reasons.

Who’s minding the store? Why aren’t pharmacists and doctors paying attention? It’s quite possible they are not being alerted as the two notification systems – the FDA and MedWatch have a 20 to 40 percent failure rate.

According to a new study published in the Archives of Internal Medicine, the FDA fails to effectively report as many as 40 percent or more of all Class I drug recalls. And is it only the FDA’s responsibility or are the drug manufacturers at fault too?
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Since 1550 B.C. humans have been experimenting with various forms of birth control. Over the last century, our options have come a long way since homemade fruit and wool concoctions.

In the early 1950s Researcher, Gregory Pincus, and Margaret Sanger, founder of the modern day, Planned Parenthood, began researching the use of hormones in contraceptives. Mexican chemist, Carl Djesarri created the first progesterone pill. A few years later, the first clinical trial was conducted in Massachusetts with 50 women volunteers.

Once on the market, almost half a million American women began taking the pill for therapeutic purposes, such as difficulties with their menstrual cycle. In May 1960, the FDA approved Envoid as a form of birth control.

50 Years later, women have the amount of birth control options have improved. However, although the amount of options has improved, that doesn’t necessarily mean that the new birth control options are improvements.

Consumers first learned in the 1970s that birth control pills came with side effects. As a result, the manufacturers began using a lower dose hormone, but warnings for side effects such as Stroke, DVT, Pulmonary Embolism, and Blood Clots, among others, are still named on the packaging inserts. In the 1970s, Chemists took a step to make new birth control safer than the predecessor, yet, today’s options are carrying more risks.
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21 years ago Zithromax gained FDA approval. Zithromax is a drug manufactured by Pfizer to treat common infections including respiratory infections such as bronchitis, pneumonia, and sinusitis. The five day course of treatment has made Zithromax a popular antibiotic among patients. However, as the drug marks its 21st birthday this year, a new study has come out that has some experts concerned about its safety.

The study published in a recent issue of the New England Journal of Medicine found that Zithromax users face twice the risk of sudden cardiac death as users of other types of antibiotics. Those at greatest risk of Zithromax sudden cardiac death appear to be those with pre-existing heart conditions.

While the FDA is recommending that people taking Zithromax continue to do so, it is important to know that the potential risk / benefit calculation has changed and that safer options may exist. Before you agree to treatment for your next infection, please talk to your doctor about your risks and about the potential benefits of your antibiotic options.

If you take OxyElite Pro then it is important that you be informed of potential risks before you take the supplement. While it is still legal to buy DMAA containing supplements, such as OxyElite Pro, in the United States, the United States Army has expressed concerns about the safety of DMAA and is currently doing a review to determine whether it should allow the supplements to be sold on Army bases. The review comes after the death of two servicemen who allegedly took DMAA supplements prior to their deaths.

Are OxyElite Pro Deaths common? There is simply not enough information to answer that question yet. With OxyElite Pro and Jack3d taken off market on Army bases, we know that there is a concern and we know that supplement users should be aware of the Army’s concerns and take the necessary steps to protect their own health.

When the FDA issues a warning, such as it did in June 2011 for the diabetes drug Actos, patients and their families often have lots of questions. In this post, we’ll answer three common questions about Actos and bladder cancer to provide you with some information that you can speak about with your doctor when discussing your diabetes treatment plan.

Question 1: When Did Actos Come on the Market? Actos came on the U.S. market in 1999. While other countries have taken Actos off the market for safety concerns, Actos remains on the market in the United States as of February 2012.

Question 2: Is Actos Safe? The FDA has warned patients and doctors that the use of Actos for more than one year, particularly in patients who have had or currently have bladder cancer, may be dangerous. Specifically, the prolonged use of Actos for these patients may increase the risk of developing bladder cancer.

Topamax (generic topiramate) is an anti-seizure medication that is also used to prevent migraine headaches. Off-label, Topamax is prescribed to treat mood instability, weight loss, Parkinson’s, stroke, and psychiatric disorders. Off-label means when a prescription medicine is used to treat a disease or condition for which the drug has not been approved by the FDA. While the FDA regulates how a medication can be advertised or promoted by the manufacturer, these regulations do not restrict a doctor’s ability to prescribe the medication for different conditions, in different doses, or for different lengths of time.

Topamax when taken during the first trimester of pregnancy may cause birth defects such as oral clefts.

Some women taking Topamax for seizures and preventing migraine headaches also tout that they have lost weight while on the drug. Weight loss is a side effect of Topamax. Some people are thrilled and others concerned. What is concerning is that taking Topamax while pregnant (when women don’t even know they’re pregnant yet) has devastating side effects on the unborn fetus.

Why would any doctor prescribe Topamax for weight loss?
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Topamax (generic topiramate) is an anti-seizure medication that is also used to prevent migraine headaches. Off-label, Topamax is prescribed to treat mood instability, weight loss, Parkinson’s, stroke, and psychiatric disorders. Off-label means when a prescription medicine is used to treat a disease or condition for which the drug has not been approved by the FDA. While the FDA regulates how a medication can be advertised or promoted by the manufacturer, these regulations do not restrict a doctor’s ability to prescribe the medication for different conditions, in different doses, or for different lengths of time.

Topamax when taken during the first trimester of pregnancy may cause birth defects such as oral clefts.

Some women taking Topamax for seizures and preventing migraine headaches also tout that they have lost weight while on the drug. Weight loss is a side effect of Topamax. Some people are thrilled and others concerned. What is concerning is that taking Topamax while pregnant (when women don’t even know they’re pregnant yet) has devastating side effects on the unborn fetus.

Why would any doctor prescribe Topamax for weight loss?
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During a recent meeting between the U.S. Food and Drug Administration (FDA) and two of its advisory panels, the safety of several common drugs used to treat female bone density problems was called into question. As a result, the FDA is anticipated to revise the labeling in November for medicines classified as bisphosphonates. Specific drug products include Actonel, Boniva, and Fosamax.

Women travelled from all over the country to share experiences involving injury with the FDA panels as part of the hearings on bisphosphonate dangers. Most of the stories showed similar factors, with the majority of cases involving a critical, abnormal fracture of the femur bone that occurred unexpectedly after using one of the listed bone density drugs for several years, in many instances five or more. According to statistics, over five million women and approximately 11 percent of females 55 years of age or older use these medicines to reduce bone density loss associated with pre-osteoporosis, which can also result in breaks and fractures. The current product labeling alerts users and their doctors to monitor for symptoms of pain which may be a sign of an impending fracture.

While it was concluded that heightened and clarified product warnings were necessary, it was not yet revealed what exactly that would entail. In a 45-page statement given by the FDA, the agency cited examples from data that suggest there are no documented benefits for using the drugs more than three to five years. The report also connected the problems testified by users to long term usage, which may or may not be part of the label revision.

Pregnant women using ongoing, big doses of the pharmaceutical fluconazole (brand name Diflucan) may run an increased risk of having children with birth defects, according to a new warning issued by the U.S. Food and Drug Administration (FDA).

Fluconazole is used to treat a variety of yeast infections, pertaining to the mouth, throat, vagina, and other areas, and associated with oropharyngeal and esophageal candidiasis, vaginal candidiasis, and cryptococcal meningitis. It’s also prescribed for its anti-fungal purposes to individuals undergoing radiation therapy and chemotherapy prior to a bone marrow transplant, and to those suffering meningitis due to a particular strain of yeast infection.

The FDA mandated additional product labeling and listed harmful doses of the medicine as 400 and 800 milligrams taken daily during an expecting woman’s first trimester (the first three months of pregnancy). No advisory has been given by the FDA for using low, single doses (150 milligrams or less) to treat vaginal yeast infections.

Many osteoporosis drugs will now be required to change their warning labels to reflect the risk of atypical fractures of the thigh and femur. According to a FDA alert, osteoporosis drugs, also known as bisphosphonates, have been linked to rare types of femur fractures. A “subtrochanteric” fracture is a rare fracture of the thigh that is just below the hip joint. A “diaphyseal” femur fracture is when a fracture along the long part of the thigh bone.

While it is not clear if osteoporosis drugs are a direct cause of rare femur fractures, there have been enough reports linking the drugs to these fractures to require a change on the warning labels. The drugs included in this category are Fosamax, Actonel, Boniva and Atelvia. A complete list is available on FDA’s website.

Prescription drugs are meant to improve a patient’s health and quality of life. Sadly, some drugs bring about more harm than good. In certain cases, drugs simply haven’t been tested enough for doctors to understand all of the potential side effects. Dangerous prescription drugs can cause catastrophic side effects, injuries or even death. Victims of unsafe drugs would be well-advised to contact a pharmaceutical liability attorney to examine their legal rights and options.

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