Category Archives: drug and pharmaceutical-law

Drug Watch: Safety Concerns Over Multaq Continue to Rise

Multaq carries a “black box warning”

Today’s post comes from guest author Edgar Romano from Pasternack Tilker Ziegler Walsh Stanton & Romano.

Multaq (also known as dronedarone) was approved by the Food & Drug Administration (“FDA”) in July of 2009 as an anti-arrhythmic drug for use in heart patients with persistent atrial fibrillation, which is the most common cardiac arrhythmia (abnormal heart rhythm), or paroxysmal (irregular heart rhythm). The drug is manufactured and marketed by Sanofi-Aventis. Multaq carries a “black box warning” which is the strongest level of warning on a prescription drug. The warning informs physicians that Multaq should not be prescribed for patients with severe congestive heart failure due to concerns that use of the drug might worsen patients’ heart failure symptoms or increase their chance of dying. In the few short years that Multaq has been sold by Sanofi-Aventis, the heart drug has been in the news quite a bit, but not because of its wonderful benefits for patients. Instead, there is growing evidence that the drug is dangerous which has led to a great deal of fear for patients and apprehension among prescribing physicians:

  • Early 2010– The FDA warned of possible problems with the development of congestive heart failure in patients taking Multaq.
  • Spring 2010 – The FDA warned of a possible link between Multaq and a potentially fatal Continue reading

What Expecting Parents Need To Know About Topamax

Topamax has been linked to an increased risk of birth defects

Today’s post comes from guest author Brenda Fulmer from Pasternack Tilker Ziegler Walsh Stanton & Romano.

Topamax, also known as topiramate, was originally approved by the Food & Drug Administration (FDA) for the treatment of seizures in epileptic patients. However, it is often prescribed “off-label” for weight loss, chronic pain, headaches, alcoholism, bulimia, and psychiatric conditions. Off-label use of medications is controversial, but not illegal.

A drug company is only permitted to market its drugs for uses that are part of the warning label and for indications for which the FDA has approved the drug after reviewing available safety data. Many pharmaceutical manufacturers, however, have faced civil and criminal penalties over the last decade for also promoting their drugs for uses for which they have not been approved by the FDA and for which they have failed to provide adequate safety information. Many physicians are unaware of the lack of safety data to support a number of off-label uses of medications, which has resulted in harm to patients.

Recently, Topamax has been linked to birth defects in children. Continue reading

Drug Watch: Darvon and Darvocet Deadly Side Effects

Today’s post comes from guest author Brenda Fulmer from Pasternack Tilker Ziegler Walsh Stanton & Romano.

Darvon and Darvocet, the branded versions of the prescription medication also known as propoxyphene, have been used for decades to treat mild to moderate pain. These drugs have been taken by millions of patients who suffered from arthritis, back injuries, trauma, surgery, and other painful conditions. These drugs have been the “go-to” painkillers for a number of primary care physicians and ER doctors for years.

Their widespread use, however, has given patients and doctors a false sense of safety. Darvon and Darvocet, which most recently have only been sold as propoxyphene by generic manufacturers, were finally recalled and pulled from the market in late 2010, after a number of patients suffered injuries or died as a result of their ingestion of the drugs.

Since propoxyphene was first launched in 1957, the Food and Drug Administration (“FDA”) has received more than 2,100 reports of serious problems relating to use of the medications, including the following:

  • Cardiac arrest;
  • Death;
  • Overdose; and
  • Suicide.

Since the FDA may only receive reports for less than 1% of adverse drug reactions, and the safety issues associated with Darvon and Darvocet have not been well publicized prior to 2010, it is likely that tens of thousands Continue reading