Wednesday, July 24, 2019

Valsartan News

A  report published as a research letter in Circulation: Cardiovascular Quality Outcomes, mapped out patterns in valsartan-associated adverse events (AEs) reported to the FDA’s Adverse Events Reporting System (FAERS). Investigators focused on reports to FAERS from January 1, 2017, to December 31, 2018, and calculated a reporting odds ratio (ROR), which captures the proportion of all reported adverse events (AEs) that were said to be neoplasms. 

The letter notes that the number of AERS reports has increased from 1.9 in June 2019, just prior to the recall, to 15.4 in July and 18.2 in August before beginning to decline. 

Read more here:

What the report fails to note is that many doctors did not link any cancer to the recalled lots. Could the cancer be the culprit? Adverse event reports are  helpful but under used. Helps keep companies on their toes (in our opinion).

Thursday, July 18, 2019

What Are the Potential Claims and Injuries Associated with TDF Drugs?

News on TDF drugs: 
TDF drugs are used to treat HIV/AIDS. The drug clinically known as tenofovir disoproxil fumarate (or TDF) was approved as an oral HIV treatment in 2001. It is an antiretroviral, which basically disrupts the progression of the HIV virus at the cellular level. The drugmaker, Gilead Sciences, markets TDF in combination with other drugs under the popular brand name, Truvada, as well as other brand names, such as Atripla, Complera, Stribild, Symfi-Lo, Cimduo and Viread. Unfortunately, studies have shown that taking TDF drugs can cause severe kidney and bone injuries.
The drugmaker has already  been sued. The lawsuits allege that Gilead knew that TDF drugs had to be given in high doses to be effective, which meant it could damage the kidneys and bones. Yet the company failed to adequately disclose those dangers in the medicine’s label.
Gilead is alleged to have developed a much safer HIV treatment compound, tenofovir alafemanide fumarate (or TAF). However, it is alleged that Gilead purposefully delayed the introduction of the safer TAF drugs, despite Gilead’s knowledge of the injuries being caused by the TDF drugs, in order to reap extended profits from Gilead’s drug patents on the TDF drugs (at the height of usage, Gilead’s TDF drugs were earning over $10 billion in annual sales). Complaints go on to assert that, after Gilead purposefully delayed the development of its TAF drugs, Gilead did eventually market TAF in combination with other drugs, under the brand names Genyova, Odefsey, Descovy and Biktarvy. But, by that time, there had already been thousands of reports of severe kidney and bone injuries from TDF drug therapy.
We are investigating these claims. Reach us anytime.