The consumer advocacy group Public Citizen has recently petitioned the FDA to recall the fungal medication ketoconazole due to concerns over an increased risk of liver damage. In their statement to the FDA, Public Citizen made the following claims:

• The risk of liver damage far outweighs the “questionable” benefits of this drug
• The FDA sent an internal memo in 2013 that classified the risks associated with ketoconazole as intolerable
• Back in 1983, the FDA had issued a black box warning, the highest safety concern they have, due to the potential for fatal liver damage

As recently as 2013, the FDA had issued a safety notice that limited the number of approved uses of ketoconazole on the product’s labeling due to the risk of liver damage, adrenal gland dysfunction, and a high risk of dangerous interactions with other drugs. Even with regards to the remaining approved uses of the drug – treatment of five different fungal infections – the FDA urged that ketoconazole only be used as a last resort. Ketoconazole has already been taken off the market in Europe due to these safety concerns.

The FDA is currently reviewing the Public Citizen petition and will hopefully make a decision shortly.

If you’ve suffered serious liver damage due to taking one of the generic forms of ketoconazole, you may be entitled to recover compensation for your damages. The pharmaceutical injury lawyers at Golomb & Honik have decades of experience handling these complex cases. They have the vast resources to take on the high powered legal teams employed by pharmaceutical companies, and they’ve earned lucrative verdicts and settlements on behalf of many drug injury victims.

Please contact Golomb & Honik using the form at the left side of the page or call 855-889-5389 today to schedule your free drug injury consultation. We serve clients nationwide from our offices in Philadelphia, Pennsylvania.

A new proposed rule that will allow generic drug makers to update their own safety warnings on labels has been delayed until the fall of 2015. The new rule has been labeled as “controversial” because it would give the makers of generic drugs the ability independently update safety warnings. This is currently something that only brand-name drug makers are allowed to do prior to receiving permission from the United States Food and Drug Administration (FDA).

An article that was recently published on the Wall Street Journal’s website makes the following comments:

• There are concerns that generic drug labeling might be insufficient to warn patients about the risks associated with certain generic medications
• Generic drug manufacturers are not required to run tests that prove their medications are exactly the same as the brand-name variety

When it comes to brand-name and generic drugs, there are many concerns about warning labels. The complexity and controversy surrounding this particular issue is the reason for the FDA’s delay in finalizing the new rule.

At Golomb & Honik, our lawyers are highly experienced in helping pharmaceutical injury victims. We know the complex laws that govern these cases, and we have the vast resources necessary to battle large pharmaceutical companies in court to recover the compensation you deserve.

If you’ve been injured due to the consumption of a generic drug, please contact Golomb & Honik today to schedule a free consultation. We serve clients nationwide from our offices in Philadelphia.

The U.S. Food and Drug Administration (FDA) recently announced that it may be dangerous to take certain vitamins and/or dietary supplements while also taking certain medications. The FDA’s announcement, which was published on October 27 and titled Mixing Medications and Dietary Supplements Can Endanger Your Health, stresses the fact that dietary supplements have the potential to either increase or decrease the absorption, effectiveness and metabolism of other prescription and over-the-counter medications that are taken simultaneously.

If you are currently taking prescription and/or over-the-counter medications, and you also regularly take vitamins or dietary supplements, your medication may not be working properly. In fact, mixing dietary supplements with certain medications could have catastrophic results. The warning issued by the FDA states that the herbal supplement ginkgo biloba and Vitamin E (which are both known as blood thinners) can increase a person’s risk of internal bleeding or stroke if they are combined with the prescription blood thinner warafin or aspirin.

The manufacturers of prescription medications and vitamin supplements have a responsibility to clearly list the risks associated with drug interactions on their labels. If you’ve suffered an injury from mixing vitamin supplements and prescription medications, you may be entitled to recover compensation for your damages. The pharmaceutical injury lawyers at Golomb & Honik will fight aggressively to protect your rights every step of the way.

Please contact Golomb & Honik, today to schedule a free pharmaceutical injury consultation. We serve clients nationwide from our offices in Philadelphia.

If you recently purchased Assured brand naproxen sodium at Dollar Tree or through the Dollar Tree website, you may have inadvertently purchased ibuprofen. Due to a packaging error, 11,640 boxes were mistakenly filled with the wrong softgel pills. The mistake and recall was announced via a press release issued by the U.S. Food and Drug Administration (FDA) on October 20, 2014. The press release states that the drug repackaging company Contract Packaging Resources is voluntarily recalling all boxes that were sold to unsuspecting customers.

The details of the product recall are as follows:

• Boxes were labeled as: Assured™ brand Naproxen Sodium Tablets 220mg, 15 count (Lot #FH4102A) [SKU #122368/UPC #639277223685]
• However, the boxes actually contained Ibuprofen softgels in 200mg strength

This is a potentially dangerous drug situation because some people are allergic to ibuprofen or have been advised to avoid ibuprofen due to medical conditions. Allergic reactions to ibuprofen can be serious and in the most severe cases can result in death.

If you erroneously purchased the mislabeled naproxen sodium at Dollar Tree and you suffered injuries because of the packaging error, you may be entitled to recover compensation for your damages. The lawyers at Golomb & Honik have decades of experience handling pharmaceutical injury cases, and we will fight aggressively to hold the negligent drug manufacturer accountable.

Please contact Golomb & Honik today to schedule your free consultation. We serve clients nationwide from our offices in Philadelphia.

When your child is sick, you want to trust that the medicine you give them is safe and effective. But when pharmaceutical companies fail to adequately label their products, the consequences can be severe.

The United States Food and Drug Administration (FDA) recently released draft guidelines intended to make children’s cold medicines safer. The new guidelines specifically address acetaminophen, sold under the brand name Tylenol and innumerable other generic marks.

The new guidance is intended to make parents more acutely aware of the dangers of acetaminophen overdose, which can cause liver damage and even death. According to the FDA, recommended doses for children have been easy for parents to confuse due to inadequate labeling.

The proposed guidelines would clarify labels on children’s medications that include acetaminophen. Noteworthy, however, is that the recommendations are completely voluntary for pharmaceutical companies.

If your child has been injured due to inadequate labeling on children’s cold medicines, you may be entitled to recover compensation for your child’s damages. The dangerous drug attorneys at Golomb & Honik have the extensive experience and vast resources necessary to take on large pharmaceutical companies, and we’ll make sure your rights are protected every step of the way.

Please contact Golomb & Honik today to arrange a complimentary case evaluation. We serve clients nationwide from our offices in Philadelphia.

Pharmaceuticals save countless lives every year, and there’s no question that society has benefitted greatly from the increased quality of life and lifespan that modern medicine offers. However, drug companies too often take advantage of consumers by prioritizing profits over product safety. Simply put, this is unacceptable, and these pharmaceutical companies must be held accountable for the damages caused by their actions.

Takeda Pharmaceuticals, manufacturer of the diabetes medication Actos is currently the focus of numerous pharmaceutical injury lawsuits because of the drug’s link to bladder cancer. In fact, the Food and Drug Administration (FDA) has warned consumers that using Actos for more than a year may be associated with a heightened risk of developing cancer.

Unfortunately, once the association between the Actos and bladder cancer was discovered, Takeda continued to market the product without adequately warning patients and doctors of the increased risk of cancer. According to a recent article in Bloomberg, executives at Tadeka were aware of the risks as early as 2004 but failed to issue any warnings until 2011 in order to keep raking in billions of dollars in profits.

The attorneys at Golomb & Honik are experienced dangerous drug attorneys and have years of experience litigating against even the largest pharmaceutical corporations. If you’ve suffered an injury due to taking Actos, we can help you recover the compensation you deserve.

Please contact Golomb & Honik today to arrange your complimentary Actos case evaluation. We serve clients nationwide from our offices in Philadelphia.