August 18, 2010
Posted by: Attorney Edgar Snyder
In March of this year, the Food and Drug Administration issued a safety alert for simvastatin, the generic name of the cholesterol drug Zocor. Even though the warning was announced months ago, I know that it probably got lost in the mix of daily news for a lot of people, so I wanted to post a reminder about the possible risks associated with the medication Research has found that patients taking an 80 mg dose of simvastatin had an increased chance of developing a serious muscle condition called rhabdomyolysis versus patients taking a lower dose. Rhabdomyolysis is the rapid breakdown of muscle fibers, a process that releases byproducts into the bloodstream and may cause acute kidney failure. Here are symptoms of rhabdomyolysis to look out for if you're taking an 80 mg dose of simvastatin or Zocor: If you experience any of these symptoms, get in touch with a doctor right away. You can also visit my firm's Zocor page for more information, including what to do if you think you've been injured by a medication containing simvastatin.
July 07, 2010
Posted by: Attorney Edgar Snyder
With all of the drugs that end up with warnings or getting recalled, you may wonder how the Food and Drug Administration (FDA) makes decisions on a drug's safety. Even the FDA admits that drug laws are vague, so what makes a drug too dangerous to be sold? The FDA's basic formula is that when the risks of a drug outweigh its benefits, it should be pulled from the market. Here are the factors that go into making that determination: - How serious is the condition treated by the drug?
- How harmful are the side effects?
- How frequently do risks outweigh benefits?
- Is there a safer alternative on the market?
A recent example of this process is the FDA's investigation of Avandia. The diabetes medication is currently being considered for recall after some tests showed it may pose health risks to seniors. Though only some tests have come to this conclusion, Avandia may still be recalled because another drug, Actos, provides the same treatment without the risks. On the other hand, estrogen-progestin pills are an instance in which a potentially dangerous drug was left on the market. In 2002, researchers found more breast cancer and heart problems among women taking the pills. However, because the absolute risk of suffering one of these complications was relatively small, and because hormones are the most effective treatment for menopause symptoms, they stayed on the market. This is a complicated issue, so if you'd like more info on the FDA's process for determining drug safety, you can read this USA Today article. You can also visit my firm's website for more information on dangerous drugs.
June 30, 2010
Posted by: Attorney Edgar Snyder
Here's a dangerous drug alert that I think you should know about: Avandia, a new medicine that treats Type 2 diabetes, has been found to have health risks for older patients. A comprehensive new study of 227,571 seniors shows that those taking Avandia had a 27% higher risk of stroke, a 25% higher risk of heart failure, and a 14% higher risk of death than those taking a similar drug called Actos. Experts say that Actos is just as effective as Avandia but doesn't pose these heath risks. Doctors recommend that patients using Avandia switch to Actos. If you take Avandia, talk to your doctor about changing your medication. Never discontinue any medication without checking with your doctor. The FDA plans to meet July 13-14 to discuss pulling Avandia from the market. To read more about Avandia, check out this WebMD article.
May 04, 2010
Posted by: Attorney Edgar Snyder
Yesterday, Johnson & Johnson recalled children's and infants' cold medicines after FDA inspections found deficiencies at their manufacturing facility. The recall includes a number of popular drugs, like Tylenol and Motrin, which are staples in medicine cabinets across the country.
This may leave you with questions like what to do if you've given your child a recalled product. USA Today has an article that answers this question and more. Check it out: Children's Medicine Recall Q&A: What Parents Should Know
February 19, 2010
Posted by: Attorney Edgar Snyder
If you or someone close to you suffers from asthma, then you might be interested in an article I found on USATODAY.com. The Food and Drug Administration has issued a warning against long-term use of the drugs Advair, Symbicort, Foradil, and Serevent because they may actually cause users' asthma to get worse. For more information, check out our website's page on risky asthma drugs, as well as USA TODAY's "FDA issues warning on 4 common asthma drugs."
December 07, 2009
Posted by: Attorney Edgar Snyder
At my law firm, we represent people who have been seriously injured due to the devastating side effects of prescription medications. That's why I was happy to hear that the FDA has taken unprecedented action to protect consumer safety by requiring risk management plans for an entire class of drugs – painkillers.
A survey conducted in 2007 found that 5.2 million people in the United States reported using prescription painkillers inappropriately, and the drugs are responsible for hundreds of fatal overdoses each year. In an effort to reduce these numbers, the FDA sent letters to 16 companies in February telling them to create risk management plans for their medications. The plans can include educational campaigns, safety labeling, and certification requirements for doctors. Pharmaceutical executives presented their plans last Friday, but the FDA said they weren't specific enough and required more work. The companies that attended the meeting manufacture 24 opioid drugs, including morphine, oxycodone, and methadone. They make generic pills as well as brand name products like Johnson & Johnson's Duragesic patch and Purdue Pharma's extended-release OxyContin. The FDA has issued a number of warnings about prescription pain pills in recent years with little effect. Hopefully, this new approach will generate a more successful result – the problem is too big and too dangerous to continue to ignore.
September 25, 2009
Posted by: Attorney Edgar Snyder
If you have children, check your medicine cabinets. Twenty-one Tylenol children’s liquid medications have been recalled due to possible contamination. Bacteria was found in an inactive ingredient that isn’t used in any final product, but was produced at the same time as these products. McNeil Consumer Healthcare, Tylenol’s manufacturer, says that the risk posed by the products is low, but that concerned parents and caregivers should contact their child’s healthcare provider. The affected medicine was manufactured between April 2008 and June 2008.
September 16, 2009
Posted by: Attorney Edgar Snyder
It seems like almost every drug now comes with a long list of safety warnings, and many people trust that if a medication has potential side effects, they are mentioned on drug labels and in advertisements. Sometimes, however, this isn't the case, and manufacturers mislead consumers. This is precisely what's being alleged against the manufacturer of popular birth control pills YAZ and Yasmin. Lawsuits filed against Bayer Healthcare Pharmaceuticals claim that the company didn't warn patients about the risks associated with the oral contraceptives while simultaneously exaggerating their benefits. Women taking YAZ and Yasmin have suffered from side effects like gallbladder problems, strokes, and Deep Vein Thrombosis (DVT), just to name a few. It's sad to think that people are under the impression they are taking something safe, while in reality the medications could be doing great harm to their health. It's frightening that women who were otherwise healthy were deceived and suffered from the serious side effects of YAZ and Yasmin. Consumers have a right be made fully aware of all potential risks associated with every drug on the market. I'm sure a lot of you have seen the YAZ ad that features corrections to Bayer's original commericals for YAZ – that's the other component to this story that I think is significant. The FDA didn't just tell Bayer to adjust the drug labeling, the agency also ordered the company to redo its commercial advertisements and correct any misrepresentations. As a frequent advertiser, I understand how important it is to make sure that you are completely accurate and forthright in your messages, and was glad to learn that this level of accountability was being enforced by the FDA. If you'd like to learn more, you can visit my firm's YAZ and Yasmin page.
July 06, 2009
Posted by: Attorney Edgar Snyder
Many of us take painkillers without even thinking about it. However, recent FDA warnings of liver damage may make you think twice. While some recommendations have been made to take the prescription drugs Vicodin and Percocet off the shelves, other experts advise targeting acetaminophen specifically by lowering its recommended daily dosage. Acetaminophen is the main component in Vicodin and Percocet as well as in extra-strength Tylenol and Excedrin. The FDA has found a connection between acetaminophen and accidental liver damage. Between 1998 and 2003, acetaminophen damage was the primary cause of acute liver failure in 22 U.S. specialty medical centers, according to an FDA study. A recent MSNBC article detailed the answers to some common questions surrounding acetaminophen. Here's some of that information that you may find useful: Q: What's the harm in taking Tylenol? Everyone uses it. A: There's no doubt it is extremely common for pain relief. According to the Journal of the American Medical Association, a 2002 study found that between 16 and 20 percent of U.S. adults use analgesics like acetaminophen and ibuprofen in any given week. The problem is that too many individuals don't consider the correct dosage amounts for the painkiller, sometimes taking 10-12 pills within 24 hours. The correct dosage is currently 4 grams of acetaminophen per day, which equals eight 500-milligram Extra Strength Tylenol. Q: Don't I have to take a lot of pills for it to have health consequences? A: No, which is one of the reasons why the FDA wants to lower the dosage recommendation of acetaminophen – even just a small amount over the recommended level can result in liver damage. The level at which damage can occur is believed to be between 5 and 7.5 grams a day, which is only an extra two to seven 500-milligram pills a day. Continue this mild overuse for days or months, or combine it with alcohol, and liver damage and even death are definite possibilities. Q: What's the story behind Percocet and Vicodin? A: These two drugs are safe if taken as prescribed by doctors, but unintentional overdoses occur when people don't know or disregard a doctor's direction. According to the FDA, prescription drugs are connected to about 60 percent of acetaminophen-related deaths. Q: How do I know if I have liver damage from acetaminophen? A: Look for the following symptoms: low fever with stomach pain, loss of appetite, or nausea; dark-colored urine and clay-colored stools; and jaundice, which is the yellowing of the skin or eyes. If left untreated, liver damage can led to liver failure, the need for a liver transplant, or death. Keep in mind that liver damage can begin with an initial phase which is followed by a period of apparent improvement. Don't take acetaminophen during that period, even if it seems as though you are recovering. When the third, most serious phase takes its course, and if you've worsened your condition by taking acetaminophen during that second phase, future recovery may be impossible. Q: What is the safe dosage of acetaminophen? A: The FDA is still determining this – it may be between 2 and 3 grams per day. In any case, it's best to decrease the strength of the pills you take as soon as possible. It's also important to remember that acetaminophen can be in prescription drugs like Percocet and Vicodin as well as over-the-counter medications like NyQuil. Take these into account when determining your daily intake of acetaminophen.
May 27, 2009
Posted by: Attorney Edgar Snyder
Hydroxycut, the popular diet drug, has been recalled, once again highlighting the need for stronger dietary supplement regulations. I think this is a topic that deserves serious discussion, since the popularity of weight loss products and other nutritional supplements continues to grow. Dangerous supplements have been in the news a lot lately – since December alone, 70 brands of pills that illegally include prescription-drug ingredients have been identified by the FDA, and consumers have been warned about their dangers. The FDA received 23 reports of adverse events like heart problems and liver damage that were linked to Hydroxycut. While 23 reports might not seem like a lot, it's impossible for the FDA to know the true extent of the problem since the agency has to depend on customers and drug manufacturers to report adverse reactions. There are a number of other shortcomings in the regulatory system. Not only do manufacturers sometimes fail to list every ingredient on product packaging, but the FDA doesn't have enough authority to test products or claims made by supplement manufacturers. In addition, many dietary supplements don't even have to be approved by the FDA's safety standards. Finally, only after consumers or physicians file reports to the FDA can the agency act. Even after that, the FDA must show a "significant or unreasonable risk of illness or injury" before testing the product and the claims in question. It seems pretty obvious that the laws should be changed to protect consumers from unsafe products and false claims. Until then, please be cautious and seek as much information as possible, preferably from sources other than the manufacturer, like a physician or pharmacist.
May 12, 2009
Posted by: Attorney Edgar Snyder
There's an interesting article in the New York Times about the dangers that drugs like aspirin and ibuprofen pose to the elderly. According to the article, the risks are so great that an expert panel for the American Geriatrics Society said it's better for adults 75 years and older to take opiates like codeine and morphine for chronic, persistent pain. To learn more click here.
May 08, 2009
Posted by: Attorney Edgar Snyder
The FDA has issued an important warning on dangerous side effects that two topical testosterone gels can have on children. The agency made the announcement after receiving reports that some children suffered serious reactions following accidental secondary exposure (coming into contact with someone who had used the medication) to AndroGel 1% and Testim 1%. Among other things, the FDA is requiring the two medications to carry warnings on their labels. For more details, you can check out the FDA's website.
March 05, 2009
Posted by: Attorney Edgar Snyder
The Supreme Court issued an important ruling yesterday. Diana Levine, a musician, lost an arm to gangrene after a drug was improperly injected into one of her arteries, and the Court upheld the $6.7 million awarded to her by a Vermont jury. Because of the Court's decision, consumers retain the right to sue drug makers for injuries suffered from medications, even if the safety warnings on the drug's label have been approved by the FDA. Click here to read the Wall Street Journal article that details this victory.
February 20, 2009
Posted by: Attorney Edgar Snyder
The health industry is a huge market in this country, especially when it comes to weight loss – about $1.7 billion was spent on weight loss pills in 2007. However, you should be aware that when you're taking these pills, even if they're labeled "natural," you might be getting more than you bargained for – undisclosed harmful drugs. The FDA has found that dozens of weight loss supplements, mostly imported from China, have unlisted pharmaceutical ingredients. To help protect consumers, the agency has created a list of weight loss supplements that contain undisclosed dangerous drugs, including StarCaps, Sliminate, Superslim, and Slip Up. Some of the supplements were sold at retailers like the Vitamin Shoppe and GNC before being recalled. Web sites like 911healthshop.com and fastdietusa.com continue to sell a lot of brands which are cited on the FDA warning list, however. Undeclared, active pharmaceutical ingredients are illegal and can cause problems like seizures, high blood pressure, or have dangerous interactions with other medications. Please make sure to check the FDA's list before you purchase or use any weight loss supplements. You also check out my firm's website for more info on dangerous drugs.
February 28, 2008
Posted by: Attorney Edgar Snyder
Last week I wrote about the dangers of Chantix, the antismoking drug that comes with a long list of dangerous side effects. This week, I want to focus on the most deadly side effect of this stop-smoking medication: suicide. At the beginning of this month, the Food and Drug Administration warned patients about nearly 40 reported suicides and over 400 cases of suicidal behavior linked to Chantix. Shortly after, New York Magazine printed an account of one man’s struggle with the deadly side effects of Chantix as they entered his mind. With no previous history of depression or mental illness, this man experienced some heavy side effects from the stop-smoking drug: "I began to wonder how I had succeeded in fooling myself that my life had any sort of value at all… Maybe I should just go downstairs and leap in front of a tour bus. Or launch my head through the computer screen…" According to the drug’s manufacturer, Pfizer, and the FDA, this man isn’t the only one who has felt suicidal after taking this antismoking drug. If you are trying to stop smoking, make sure you talk to your doctor about the side effects of Chantix. If you are already taking the drug, make sure to consult with your physician and find out if you may be at serious risk for suicidality.
February 21, 2008
Posted by: Attorney Edgar Snyder
It’s no secret that smoking cigarettes can take a serious toll on your health. There are many benefits to cutting nicotine and tobacco out of your life. But you might find that the risks outweigh the benefits if you’re trying to stop smoking by taking Chantix. Chantix is a prescription antismoking drug that has been in the news recently thanks to its dangerous side effects. At the top of the side effects list is “suicidality” – that means Chantix patients may experience suicidal thoughts and behaviors. Anxiety, aggressiveness, and unusually vivid dreams have also been reported by patients as well. Most drug companies set out to make medication that helps people get better. But Chantix wasn’t fully tested in its clinical trials and now the prescription patients are the ones who suffer for that mistake. While I applaud anyone who attempts to quit smoking, be careful if you decide to use Chantix to kick the habit – the side effects may be more than you bargained for.
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