Johnson & Johnson Eyes New Oversight Panel in Light of Topamax Side Effects

Trenton, NJJohnson & Johnson, which has dealt with a number of recalls and heavy criticism over Topamax side effects and other products with quality control issues in recent years, reportedly plans to create a new oversight panel.

According to The Associated Press, the strategy is part of a number of recommendations made by a special committee of the pharmaceutical giant's board of directors in a report filed with the US District Court in Trenton, New Jersey.

The court is reportedly overseeing lawsuits from shareholders that accuse the company of breaching its fiduciary duty by allowing the recalls and other charges to occur, according to the news source.

Some of the claims made against Johnson & Johnson include that the company marketed its medications for uses that were not approved by the US Food and Drug Administration and had lax quality control standards at some of its manufacturing plants.

The special committee of the board of directors, in their 127-page report, wrote that there were no signs that the company's compliance monitoring system would be prone to failure. Additionally, the committee said when problems popped up, they were properly dealt with by the company.

The committee members also recommended that the company should not continue pursuing the shareholder lawsuits, but rather move to have the litigation dismissed, according to the news provider.

The recommendations are a direct result of the compliance issues and recalls Johnson & Johnson has endured recently. Last year, for instance, subsidiaries of the company agreed to pay $81 million over allegations that it illegally promoted the anti-epileptic drug Topamax—whose generic name is topiramate—for psychiatric use. Drug regulators had only reportedly cleared Topamax for treating epilepsy and migraines, the news source said.

Some Topamax side effects that have been publicized in studies include birth defects such as cleft lip or cleft palate, according to the FDA. More common side effects can include headache, drowsiness and mood swings, according to the National Center for Biotechnology Information.

Additionally, Johnson & Johnson has issued more than 25 product recalls since September 2009, with products like Tylenol, Risperdal, Prezista and Topamax headlining the list. A number of these recalls came as a result of a musty odor emanating from the bottles.

More serious recall reasons, however, included pieces of metal contaminating liquid medicines and some products having incorrect amounts of the active ingredient, the news source said.