PA Law Blogs » FDA Recalls

Actos Taken Off the Market

Michael Monheit — Mon, 17 Oct 2011 17:58:31 +0000

Actos Taken Off Markets for Increased Bladder Cancer Risk.

The medication Actos, (pioglitazone) and all pioglitazone-containing medications have been removed from the market in France and Germany since June, 2011. This action was taken after a French government-funded study in France found a link between Actos and bladder cancer.

In response to the French results as well as a study conducted in the United States at Kaiser Permanente in Northern California, (which showed Actos increased the risk for bladder cancer 40%) the FDA, while not removing Actos from the market, has issued new safety warnings.

Actos Taken Off of International Markets
The FDA is now warning the public that using Actos for more than one year may be associated with an increased risk of bladder cancer. It recommends that healthcare professionals should not use Actos or pioglitazone-containing medications in patients with active bladder cancer and that Actos and pioglitazone-containing medications be used with caution in patients with a prior history of bladder cancer.

It remains to be seen if Actos and other pioglitazone-containing medications will be removed from the market in the United States as it was in France and Germany. In the meantime, do not stop taking any medications without a physician’s direction and be sure to discuss any concerns you may have with your physician.

Topamax use expanded greatly in 2004, which is a good reason for even more vigilance by the manufacturer

Jim Ronca — Fri, 01 Apr 2011 15:30:25 +0000

Originally Topamax (also known as topiramate) was approved for prevention of seizures, a potentially life threatening condition.

In 2004, Topamax was approved by the FDA for prevention of migraine headaches. While migraine headaches may be very painful and temporarily disabling, they are not life threatening. Migraine headaches also affect many more people than seizures.

So when Topamax was approved for migraine prevention, sales went way up and many more people were exposed to this drug, including women of child bearing age.

Because it was known that Topamax had been associated with major fetal malformations when given to laboratory animals, extra caution should have been applied in determining whether Topamax use during pregnancy would result in birth defects.

In 2008, a program in Great Britain to register pregnant women and analyze the relationship between certain medications and birth defects saw a troubling trend toward increased risk of cleft lip , cleft palate and other major malformations in the babies of women who took Topamax during the first trimester. While there weren’t enough cases in the United Kingdom’s registry to prove the connection, the increased risk was significant. And this was based on data that certainly was assembled before the publication date.

Might the greater number of pregnant women exposed in the United States resulted in a clearer picture and an earlier warning?

We don’t know at this point and certainly litigation concerning this point and the review of internal documents by experienced lawyers will bring the evidence to light. If the British data questioned Topamax in 2008, and showed the rate of cleft palate or cleft lip at 11 times the background rate, shouldn’t some warning bells have gone off before the FDA changed the warning in March 2011.

Three to four years had gone by and likely hundreds of babies exposed to Topamax while still in the womb. What are your thoughts on this??

Cleft Palate Advocacy Groups Work Together for a Better World

Michael Monheit — Wed, 30 Mar 2011 11:06:10 +0000

The Oscar-winning film, “The King’s Speech” demonstrates how long-term speech therapy can change lives, not only for patients but for their families too.

People have long been misinformed that a single cleft palate surgery fixes the problem.

That is so not the case.

The Canadian based Transforming Faces Worldwide and the European Cleft Organization are escalating the cleft care management dialogue to include greater needs of children born with cleft defects. While most of that care is available to children in developed nations, children in third world countries can only hope.

While much has been achieved in providing children with reconstructive surgery, there is still much more to be done so these children are able to eat, speak, perform at school and live a normal life.

Both organizations envision treatment that doesn’t start and stop with surgery but encourages extensive follow-up care.

Hyland’s Teething Tablets Recalled

Michael Monheit — Tue, 26 Oct 2010 22:53:20 +0000

On October 23, the U.S. Food and Drug Administration (FDA) announced the recall of Hyland’s Teething Tablets because the tablets may pose a serious risk to children. The tablets contain small amounts of a substance by the name of belladonna that can cause a child serious harm in large doses. In laboratory testing and analysis, the FDA found that the tablets contained inconsistent amounts of the harmful substance, which triggered the recall.

The FDA has received several reports similar to symptoms of belladonna toxicity in regards to children and the Hyland’s Teething Tablets, and have also received alarming reports of children who were able to consume more tablets than is recommended because there is not a child resistant cap on the tablet containers.

The FDA recommends that consumers immediately stop using Hyland’s Teething Tablets and dispose of any Tablets they currently possess.

If your child shows symptoms similar to toxicity, which include difficulty breathing, excessive sleepiness, weak muscles, seizures, flushing of the skin, constipation or difficulty urinating after taking Hyland’s Teething Tablet, consult a healthcare professional immediately.

If you or your child has been injured by a dangerous drug, it would be wise to contact a skilled Pennsylvania dangerous drug attorney. Compensation may be available for any injuries you may have suffered.

Anemia Drugs Recalled by Amgen and Johnson & Johnson

Michael Monheit — Thu, 30 Sep 2010 22:09:07 +0000

As a medical condition that causes iron deficiency and depletes a person of healthy red blood cells, anemia is serious and typically requires prescription medication to help treat symptoms. While anemic patients trust that the medications they are prescribed are safe, recent problems with Amgen and Johnson & Johnson anemia drugs have shown that manufacturers may overlook potentially dangerous contamination or severe side effects.

The New York Times reports that Amgen and Johnson & Johnson are recalling different lots of the anemia drugs, Epogen and Procrit, due to the chance that thin, glass flakes may be present in the drugs’ vials. While Amgen has not received any complaints or reports of problems that can be “directly attributed to” the glass particles that have been found in its product, the company stated that the particles could lead to clots and other problems if the drugs are administered through intravenous infusion. The drug manufacturer also said that if Epogen was injected under the skin, the small particles may cause lumps or immune system reactions.

Moreover, evidence has continued to accumulate linking the overuse of these anemia drugs to heart attacks, strokes, or the worsening of cancer. Even though the Food and Drug Administration has included additional warning labels for these drugs, the agency will conduct another advisory committee meeting to evaluate the most recent data regarding possible risks for patients with kidney disease.

Patients who suffer serious side effects or worsened medical conditions from a contaminated pharmaceutical product may be able to hold negligent drug manufacturers liable with the help of a drug recall attorney. This may also apply if a patient suffers harm due to improper warning labels on a pharmaceutical product.

FDA Announces Gadolinium-Based MRI Contrast Agent Warning

Michael Monheit — Mon, 13 Sep 2010 23:42:58 +0000

The Food and Drug Administration (FDA) has announced a change in the labeling of gadolinium-based contrast agents used in magnetic resonance imaging (MRI) scans. Although these agents are used to enhance the quality of images from the scan, they have been linked to causing nephrogenic systemic fibrosis (NSF), which causes hardening of the skin and tissue growth on joints, eyes, and internal organs, in patients with weakened kidney function. There is no known cure for this medical condition, which can be deadly in some cases. Moreover, no reports have been made for NSF in patients with normal kidney function.

An Associated Press report mentions that even though a warning label already exists cautioning physicians and/or radiologists about screening patients for kidney problems, the new FDA warning label is the strongest that the agency can administer. Five gadolinium-based contrast agents have been approved for use since 1988 by the FDA. Bayer Bayer Healthcare’s Magnevist, General Electric Healthcare’s Omniscan and Covidien’s Optimark are the three agents that pose the most risk to patients with kidney ailments.

MRI scans give doctors information about patients’ medical conditions so that appropriate treatment can be provided. However, the improper administration of contrast agents for MRIs puts patients at extreme risk. Those who have suffered NSF due to a medical professional’s oversight may wish to seek legal guidance and learn more about their legal options.

Read more about the drug safety alert here.

FDA Widening McNeil Drug Recall Investigation

Michael Monheit — Tue, 29 Jun 2010 00:01:23 +0000

The U.S. Food and Drug Administration (FDA) is investigating reports of at least 775 cases of adverse side effects from drugs that were recalled by McNeil. According to a Fox News report, these serious side effects included death. FDA officials are investigating seven fatalities since the May 1 recall of a number of children’s medications manufactured by McNeil. But so far, no definite associations have been made. Congress is expected to look further into this investigation.

The recalled drugs were manufactured at the company’s plant in Fort Washington, reports a www.myfoxphilly.com article. Federal officials are saying that the “adverse events” and side effects do seem to be connected to the recall. McNeil is a division of Johnson & Johnson.

All drugs have some side effect or another. However, a defective or contaminated drug can potentially create severe reactions that may lead to fatality. Victims who have been seriously injured as a result of a drug manufacturing defect, design flaw, or inaccurate warning label may be able to receive compensation for their losses. Product liability attorneys in Philadelphia strive to protect consumer rights in defective product or dangerous drug cases.

Drug Contamination Leads to FDA Recall

Michael Monheit — Fri, 21 May 2010 18:36:58 +0000

Pharmaceutical drugs have the power to cure or mitigate the symptoms of many illnesses and chronic diseases. They can result in a tremendous improvement of quality of life. However, quality control is a crucial part of drug manufacturing. The chemicals and ingredients that go into these medications are potent and must be combined with precision. When drugs become contaminated because of the introduction of foreign substances, the consequences can be catastrophic or even fatal.

The most recent FDA recall involves Sagent Pharmaceuticals’ metronidazole injection, USP 500mg / 100mL, manufactured by Claris Lifesciences and distributed by Sagent. The recall follows the discovery of non-sterility in two lots of metronidazole injection. This product defect involving the contamination of the antimicrobial drug that is administered intravenously to patients has the potential to result in infections. Based on a US Recall News report, the infections, in turn, could be lethal particularly in patients with compromised immune systems.

It is well-known that almost all drugs have potential side effects. But when serious injuries or fatalities occur as the result of negligence on the part of the drug manufacturer, injured victims or their families have a right to compensation and may want to contact a skilled Philadelphia, PA product liability attorney.

FDA to Decide on Approval of Prostate Cancer Vaccine

Deborah Forrister — Thu, 29 Apr 2010 17:41:57 +0000

Vaccine and various other pharmaceutical manufacturers must conduct several tests and invest a substantial amount of money and time before the U.S. Food and Drug Administration (FDA) approves their product for patient and consumer use. A prostate-cancer vaccine, Provenge, has been 20 years in the making. If approved by the FDA, Provenge would represent a milestone in therapeutic cancer vaccine science and development. But are potential dangerous side effects ruled-out?

According to the Nature Publishing Group, the FDA is scheduled to make a decision regarding Provenge’s approval by May 1. Interestingly, some vaccines have received license to be used in other countries; however, no vaccines have been allowed on the U.S. market. Based on the article, a university of Pittsburgh School of Medicine immunologist stated that an FDA-approved vaccine “would legitimize the field” and provide prospective new treatment for male patients with highly developed prostate cancer.

The functionality of Provenge relies on being custom-made for each particular patient by harvesting one of his immune cells and exposing them to a cancer-related protein called prostatic acid phosphatase. When the vaccine is given to the patient, the exposed cells are supposed to initiate an immune assault on tumor cells.

For officials, consumers and vaccine injury lawyers who may be questioning the safety of the vaccine, others hope that Provenge will help lower the amount of prostate cancer deaths, which amounted to over 28,000 men in the United States in 2008, according to the article. One of the main concerns with any new vaccine or drug is making sure that it will not create any potential or new health problems due to an undetected manufacturing or design flaw. Similarly, manufacturers are responsible for conducting a wide scope of clinical trials to ensure that any potential side effects are identified and outweigh the risk of not taking the product.

FDA Warning Letters – Drug Contamination and Manufacturing Defects

Deborah Forrister — Mon, 19 Apr 2010 16:58:38 +0000

When a drug manufacturing company issues its second pharmaceutical recall within a span of six months, a real solution to prevent manufacturing defects and contamination must be established. The first step in making sure that such reform takes place is not only through a recall, but also an FDA warning letter, which is supposed to kick a drug manufacturing company into high-gear solution decision-making.

As a Business Week report mentions, after Hospira Inc. announced a recall for Propofol and Liposyn for the second time on April 1, 2010 since six months ago, the U.S. Food and Drug Administration issued a warning letter on April 12. As two vital drugs that were sold to medical professionals and hospitals, Propofol (an anesthetic agent) and Liposyn (an intravenous nutritional product) were contaminated with particulates from the manufacturing process. Hospira recalled both of these products in October 2009 due to equipment failure at the Clayton, North Carolina manufacturing facility. Apparently, as the FDA was examining the Clayton plant in January and February, agency officials also reviewed Hospira’s Rocky Mount, North Carolina plant. It was at this second location where the FDA discovered a malfunction to authorize the processes utilized in manufacture.

While pharmaceutical products should be designed and manufactured to help people, some consumers are left to wonder whether the timeframe of these processes is cut-down in order to boost profits. If a drug maker rushes through significant elements of the manufacturing process, mistakes can be made, and flaws or defects may be left overlooked until innocent people suffer as a result. Fortunately, in the case of Propofol and Liposyn, no reports of patients experiencing serious side effects or injury have been reported at this time.

In instances where a drug company or individual breaches FDA rules, before resulting to more extreme measures, the FDA first works with the company or individual in reviewing manufacturing operations and establishing ways for regulations to be better implemented. Especially when the same two products have experienced two different issues that have prompted recalls, the FDA will also issue warning letters that are meant to encourage a drug manufacturer (or any other manufacturer or seller of medical devices, food, cosmetics, or various other products) to make and follow voluntary solutions to the issue.